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• Louisiana Affordable Trademarks and Copyrights
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• Minnesota Affordable Trademarks and Copyrights
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• Mississippi Affordable Trademarks and Copyrights
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What happens at a Criminal Preliminary Exam (Examination)?

January 15, 2021 - Categories: Legal Articles

In a felony criminal case, one of the hearings is a Preliminary Examination.

What is the Purpose of a Preliminary Examination (aka "Prelim Exam" or "Preliminary Exam")

A preliminary examination is like a "mini-trial" in that it is an evidentiary hearing, but the reason for it is not to find guilt or innocence of the Defendant, but rather for the State (i.e. State's Attorney, Prosecuting Attorney, etc) to present evidence to the Judge, and convince the Judge, that there is at least "probable cause" that a crime was committed, and that the Defendant committed it. 

If the State cannot prove at least probable cause, then the Judge must dismiss the case, and it is over.

If the State CAN prove at least probable cause, it does NOT mean that the Defendant is proven guilty; it only means that the case will not be dismissed, and instead will proceed to the next steps in the case of: Binding over to Circuit Court, Arraignment at Circuit Court, Pretrial, Negotiation, Entry of Plea deal or Trial, and then either Sentencing (if a plea deal was entered, or if found guilty at Trial) or Dismissal (if Defendant was found not guilty at trial). 

What does it mean to prove "Probable Cause"?

Proving at least "probable cause" is a very low standard of proof. The state only needs to show evidence establishing probable cause, which is a "reasonable ground for supposing that a charge is well-founded".

In other words, the State must only show evidence to give the Judge a reasonable basis for believing that a crime committed and a reasonable basis that the Defendant committed it.

Because the preliminary examination is not to actually prove guilt or innocence, probable cause is a very low and easy standard for the State to meet. 

What is the difference between "Probable Cause" and "Guilty beyond a reasonable doubt?"

"Probable Cause" is the standard that the State must meet at a preliminary examination. This differs markedly from the standard of "Guilty beyond a reasonable doubt" that the State must meet at a regular Trial. 

At a regular trial, the State must show enough evidence to convince a unanimous jury that the Defendant committed the crime "beyond any reasonable doubt." 

The "Guilt beyond Reasonable Doubt" standard means that the State must essentially prove first that, looking at all of the evidence from both sides, there is no reasonable alternative explanation other than that: 1) a criminal act was committed; 2) the Defendant committed the act; and 3) the Defendant did not have a legal reason that allowed him/her to commit it (e.g. self-defense).

Conversely, the Defense at a TRIAL can win by giving enough evidence to create at least one or more alternative reasonable explanations as to what occurred, leading the jury to believe that it is reasonably possible that:  1) a criminal act was NOT committed; 2) OR that one was committed, but the Defendant did not commit the act (i.e. someone else did); or 3) the Defendant committed the act, but had a legal reason that allowed him/her to commit the act (e.g. self-defense).

Thus, at a trial, the State has a much more difficult job because they have a higher standard of proof (beyond any reasonable doubt), and because they must convince all 12 jurors (or whatever the number), unanimously, that the charged crime was committed and that the Defendant committed it beyond any reasonable doubt.

In a Preliminary Exam, however, the Prosecution has a much easier job because they have a lower standard of proof (probable cause, i.e. any reasonable basis that a crime was committed and that the Defendant committed it, without actually proving he/she did), and because they must only convince one judge (not all jurors) of that reasonable basis for proceeding.

As a result, very few cases get dismissed, and nearly all of them move on the next phase of the criminal process.

Does the Defendant get to prove his defense at a Preliminary Exam?

Unfortunately, the Defense is limited as to what it wise to do at a Preliminary Examination. Certainly, the Defendant could testify, but that is usually not a good idea.

The reason a Defense Attorney does not usually have a Defendant testify at a preliminary examination is because 1) the chances of success are so low of prevailing at this point in the criminal process; and 2) the risks are high of the Defendant saying something under oath, even some random minor fact, that could later be challenged at trial to undermine his/her credibility. Therefore, the risks are usually not worth the possible reward of a dismissed case.

On the other hand, the Defense could present other witnesses who can testify on behalf of the Defendant, and these can be very helpful. For example, if another witness can testify that the Defendant was with them in an entirely different location at the time the crime occurred, and the judge believes that witness, this can eliminate all probable cause.

The Defense can also provide text messages or other documents to remove probable cause. For example, if the Defense has text messages from the alleged victim which prove that the crime was not committed, then this can be enough to overcome probable cause, leading to dismissal.

On the other hand, if the case is merely "he-said, she-said," and you have the alleged victim testifying that the Defendant committed the crime, and there are no other documents or witnesses by the Defense to prove otherwise, then it is not usually worth it to have the Defendant testify "no I didn't" because in a he-said/she-said scenario, the alleged victim's testimony, even if contradicted, is enough to provide a reasonable basis for the charges continuing forward. It may not be enough to convince a jury of 12 at a later trial that the Defendant committed the crime, but it is more than enough evidence at a prelim examination.

So what's the point of a Defendant proceeding with a preliminary exam?

Because of the low rate of success for the Defendant at a prelim exam, some attorneys will advise the client to "waive" their right to a prelim exam and to proceed to the next phase of the case. And in some cases, this is good advice.

However, in this attorney's opinion, most of time a preliminary exam should NOT be waived, because there are still benefits, as follows:

1) If there are other witnesses to testify on the Defendant's behalf, they should be brought, and may help get the case dismissed.

2) The Defense Attorney will have the opportunity to cross-examine the alleged victim and/or witnesses for the State, thus hopefully causing them to say something under oath that can be immediately challeged with contradictory statements they made, contradictory evidence at hand, or later under oath at trial.

3) The preliminary examination allows the Defense to get a more fuller picture of the witness statements and evidence that is available, and the State's position on what the evidence shows, which helps the Defense to prepare for trial later, or to have a better idea of how strong/weak the State's case will be.

4) The preliminary exam allows you to lock in the State witnesses' testimony, and then later if those witnesses testify differently at trial, you can point out the contradictions in testimony under oath, thus causing the jury to find the witness(es) less credible at trial.

5) If the Defendant is out on bond, and wants to delay the case as long as possible, this is one more hearing that will cause the case to take longer.

For these reasons, it is often a good idea to have a Preliminary Examination. 

However, it is important for the Defendant to realize that the chance of "success" and "dismissal" after a Preliminary Examination is very low, should not be expected under any circumstances, and it is not the place for the Defense to put on their full case of evidence, testimony, and defenses. That will come later at trial. 

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MENU Steps in the Federal Criminal Process

• Investigation
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After many weeks or months of preparation, the prosecutor is ready for the most important part of his job: the trial. The trial is a structured process where the facts of a case are presented to a jury, and they decide if the defendant is guilty or not guilty of the charge offered. During trial, the prosecutor uses witnesses and evidence to prove to the jury that the defendant committed the crime(s). The defendant, represented by an attorney, also tells his side of the story using witnesses and evidence.

In a trial, the judge — the impartial person in charge of the trial — decides what evidence can be shown to the jury. A judge is similar to a referee in a game, they are not there to play for one side or the other but to make sure the entire process is played fairly.

Jury Selection

At trial, one of the first things a prosecutor and defense attorney must do is the selection of jurors for the case. Jurors are selected to listen to the facts of the case and to determine if the defendant committed the crime. Twelve jurors are selected randomly from the jury pool (also called the “venire”), a list of potential jurors compiled from voter registration records of people living in the Federal district.

When selecting the jury, the prosecutor and defense attorney may not discriminate against any group of people. For example, the judge will not allow them to select only men or only women. A jury should represent all types of people, races, and cultures. Both lawyers are allowed to ask questions about their potential biases and may excuse jurors from service. Each side is allowed to excuse certain potential jurors without providing a reason by using a limited number of “peremptory challenges.”

Opening Statements

Opening statements allow the prosecutor and the defense attorney to briefly tell their account of the events. These statements usually are short like an outline and do not involve witnesses or evidence. The prosecutor makes an opening statement first because the Government has the burden of proving that the defendant committed the crime.

Presentment of Cases

Witness Examination Following opening statements, the prosecutor begins direct examination of his first witness. This is the prosecutor’s initial step in attempting to prove the case, and it can last from a few minutes to several days. During direct examination, the prosecutor can introduce evidence such as a weapon or something from the crime scene.

Following the prosecutor’s examination of a witness, the defense attorney has an opportunity to cross examine or ask questions to the same witness. The purpose of cross examination is to create doubt as to the credibility of the witness.

After the defense attorney cross examines the witness, the prosecutor asks the witness final questions to clarify any confusing testimony for the jury. This is called redirect examination. Once the process of direct examination, cross examination, and redirect of all the witnesses is complete, the prosecutor rests his case. After the prosecutor rests, no more witnesses can be called to the stand or evidence introduced by the government.

After the Government rests, the defense has the opportunity to present witnesses and evidence to the jury. The defense also has the option of not having the defendant testify. There is no burden upon the defendant to prove that they are innocent. It is the government's responsibility to prove the defendant committed the crime as detailed in the indictment. The fact that a defendant did not testify may not be considered by the jury as proof that the defendant committed the crime. The defense may also waive his case. If the defense does not put on any evidence, the jury cannot assume that the defendant is guilty simply because they did not put on a defense. The decision to put on a defense is solely up to the defendant and the defense attorney. However, the defense will usually present its own version of the case.

Objections During direct or cross examination, either attorney can make an objection to a question or a piece of evidence to the judge. For example, a prosecutor or defense attorney may object to the wide range of the direct examination because it is beyond the knowledge of the witness, the attorney may be arguing with the witness rather than asking questions, or the witness may be talking about things irrelevant to the case.

Common objections include:

• Hearsay – Statement by a witness who did not see or hear the incident in question but learned about it through secondhand information such as another’s statement, a newspaper, or a document.
• Relevance – Testimony and evidence presented at trial must be relevant to the case.

The judge decides the outcome of an objection, sometimes after allowing attorneys on both sides to comment before making a ruling. The judge either “sustains” the objection so that the action stops, or they “overrule” the objection and allows the action to continue.

Closing Arguments After the defense’s direct testimony and cross examination by the prosecutor of all the witnesses, the defense rests, and the prosecutor and defense attorney prepare for closing arguments.

Closing arguments are the final opportunity for the prosecutor and the defense attorney to talk to the jury. These arguments allow both attorneys to summarize the testimony and evidence, and ask the jury to return a verdict of guilty or not guilty.

Jury Instructions

Following the closing arguments, the judge “charges the jury,” or informs them of the appropriate law and of what they must do to reach a verdict.

Jury Deliberations & Announcement of the Verdict

After being charged, the jury goes into deliberation, the process of deciding whether a defendant is guilty or not guilty. During this process, no one associated with the trial can contact the jury without the judges and lawyers. If the jury has a question on the law, they must write a note to the judge, which the judge will read in court with all parties present. In federal criminal trials, the jury must reach a unanimous decision in order to convict the defendant.

After they reach an agreement on a verdict, they notify the judge, the lawyers, and the defendant in open court. Everyone is present in court for the reading of the verdict. The United States Marshals Service is present during trial to protect the judge and prosecutors from potential harm. If the defendant is found not guilty, they are usually free to go home.

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Sequential, Multiple Assignment, Randomized Trial Designs

• 1 Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor
• 2 Survey Research Center, Institute for Social Research, University of Michigan, Ann Arbor
• 3 Department of Statistics, University of Michigan, Ann Arbor
• JAMA Guide to Statistics and Methods Collider Bias Mathias J. Holmberg, MD, MPH, PhD; Lars W. Andersen, MD, MPH, PhD, DMSc JAMA
• Special Communication Reporting of Factorial Randomized Trials Brennan C. Kahan, PhD; Sophie S. Hall, PhD; Elaine M. Beller, MAppStat; Megan Birchenall, BSc; An-Wen Chan, MD, DPhil; Diana Elbourne, PhD; Paul Little, MD; John Fletcher, MPH; Robert M. Golub, MD; Beatriz Goulao, PhD; Sally Hopewell, DPhil; Nazrul Islam, PhD; Merrick Zwarenstein, MBBCh, PhD; Edmund Juszczak, MSc; Alan A. Montgomery, PhD JAMA
• Original Investigation Comparison of Teleintegrated Care and Telereferral Care for Treating Complex Psychiatric Disorders in Primary Care John C. Fortney, PhD; Amy M. Bauer, MS, MD; Joseph M. Cerimele, MPH, MD; Jeffrey M. Pyne, MD; Paul Pfeiffer, MD; Patrick J. Heagerty, PhD; Matt Hawrilenko, PhD; Melissa J. Zielinski, PhD; Debra Kaysen, PhD; Deborah J. Bowen, PhD; Danna L. Moore, PhD; Lori Ferro, MHA; Karla Metzger, MSW; Stephanie Shushan, MHA; Erin Hafer, MPH; John Paul Nolan, AAS; Gregory W. Dalack, MD; Jürgen Unützer, MPH, MD JAMA Psychiatry

An adaptive intervention is a set of diagnostic, preventive, therapeutic, or engagement strategies that are used in stages, and the selection of the intervention at each stage is based on defined decision rules. At the beginning of each stage in care, treatment may be changed by the clinician to suit the needs of the patient. Typical adaptations include intensifying an ongoing treatment or adding or switching to another treatment. These decisions are made in response to changes in the patient’s status, such as a patient’s early response to, or engagement with, a prior treatment. The patient experiences an adaptive intervention as a sequence of personalized treatments.

Read More About

Kidwell KM , Almirall D. Sequential, Multiple Assignment, Randomized Trial Designs. JAMA. 2023;329(4):336–337. doi:10.1001/jama.2022.24324

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• Published: 14 September 2024

Datopotamab–deruxtecan plus durvalumab in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial

• Rebecca A. Shatsky 1   na1 ,
• Meghna S. Trivedi 2   na1 ,
• Christina Yau 3 ,
• Rita Nanda   ORCID: orcid.org/0000-0001-5248-0876 4 ,
• Hope S. Rugo   ORCID: orcid.org/0000-0001-6710-4814 3 ,
• Marie Davidian 5 ,
• Butch Tsiatis 5 ,
• Anne M. Wallace 1 ,
• A. Jo Chien 3 ,
• Erica Stringer-Reasor 6 ,
• Judy C. Boughey   ORCID: orcid.org/0000-0003-3820-3228 7 ,
• Coral Omene 8 , 9 ,
• Mariya Rozenblit 10 ,
• Kevin Kalinsky   ORCID: orcid.org/0000-0002-3113-7902 11 ,
• Anthony D. Elias 12 ,
• Christos Vaklavas   ORCID: orcid.org/0000-0002-9919-2748 13 ,
• Heather Beckwith 14 ,
• Nicole Williams 15 ,
• Mili Arora 16 ,
• Chaitali Nangia 17 ,
• Evanthia T. Roussos Torres   ORCID: orcid.org/0000-0002-0740-5102 18 ,
• Brittani Thomas 19 ,
• Kathy S. Albain 20 ,
• Amy S. Clark 21 ,
• Carla Falkson 22 ,
• Dawn L. Hershman 2 ,
• Claudine Isaacs   ORCID: orcid.org/0000-0002-9646-1260 23 ,
• Alexandra Thomas   ORCID: orcid.org/0000-0001-9022-2229 24 ,
• Jennifer Tseng 25 ,
• Amy Sanford 26 ,
• Kay Yeung 1 ,
• Sarah Boles 1 ,
• Yunni Yi Chen 3 ,
• Laura Huppert 3 ,
• Nusrat Jahan 6 ,
• Catherine Parker 6 ,
• Karthik Giridhar 7 ,
• Frederick M. Howard 4 ,
• M. Michele Blackwood 8 ,
• Tara Sanft 10 ,
• Natsuko Onishi   ORCID: orcid.org/0000-0003-4495-9187 3 ,
• Adam L. Asare 3 , 27 ,
• Philip Beineke 27 ,
• Peter Norwood 27 ,
• Lamorna Brown-Swigart   ORCID: orcid.org/0000-0003-2076-5177 3 ,
• Gillian L. Hirst   ORCID: orcid.org/0000-0002-4502-0035 3 ,
• Jeffrey B. Matthews 3 ,
• Brian Moore 24 ,
• W. Fraser Symmans   ORCID: orcid.org/0000-0002-1526-184X 28 ,
• Elissa Price 3 ,
• Diane Heditsian 3 ,
• Barbara LeStage 3 ,
• Jane Perlmutter 29 ,
• Paula Pohlmann   ORCID: orcid.org/0000-0001-7914-5162 28 ,
• Angela DeMichele   ORCID: orcid.org/0000-0003-1297-4251 21 ,
• Douglas Yee   ORCID: orcid.org/0000-0002-3387-4009 14 ,
• Laura J. van ’t Veer   ORCID: orcid.org/0000-0002-9838-8298 3 ,
• Nola M. Hylton 3 &
• Laura J. Esserman   ORCID: orcid.org/0000-0001-9202-4568 3  

Nature Medicine ( 2024 ) Cite this article

3 Altmetric

Metrics details

• Breast cancer
• Clinical trial design

Sequential adaptive trial designs can help accomplish the goals of personalized medicine, optimizing outcomes and avoiding unnecessary toxicity. Here we describe the results of incorporating a promising antibody–drug conjugate, datopotamab–deruxtecan (Dato-DXd) in combination with programmed cell death-ligand 1 inhibitor, durvalumab, as the first sequence of therapy in the I-SPY2.2 phase 2 neoadjuvant sequential multiple assignment randomization trial for high-risk stage 2/3 breast cancer. The trial includes three blocks of treatment, with initial randomization to different experimental agent(s) (block A), followed by a taxane-based regimen tailored to tumor subtype (block B), followed by doxorubicin–cyclophosphamide (block C). Subtype-specific algorithms based on magnetic resonance imaging volume change and core biopsy guide treatment redirection after each block, including the option of early surgical resection in patients predicted to have a high likelihood of pathologic complete response, which is the primary endpoint assessed when resection occurs. There are two primary efficacy analyses: after block A and across all blocks for six prespecified HER2-negative subtypes (defined by hormone receptor status and/or response-predictive subtypes). In total, 106 patients were treated with Dato-DXd/durvalumab in block A. In the immune-positive subtype, Dato-DXd/durvalumab exceeded the prespecified threshold for success (graduated) after block A; and across all blocks, pathologic complete response rates were equivalent to the rate expected for the standard of care (79%), but 54% achieved that result after Dato-DXd/durvalumab alone (block A) and 92% without doxorubicin–cyclophosphamide (after blocks A + B). The treatment strategy across all blocks graduated in the hormone-negative/immune-negative subtype. No new toxicities were observed. Stomatitis was the most common side effect in block A. No patients receiving block A treatment alone had adrenal insufficiency. Dato-DXd/durvalumab is a promising therapy combination that can eliminate standard chemotherapy in many patients, particularly the immune-positive subtype.

ClinicalTrials.gov registration: NCT01042379 .

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Data availability

De-identified participant-level data and/or clinical specimens are made available to members of the research community upon approval of the I-SPY Data Access and Publications Committee. Details of the application and review process are available at https://www.quantumleaphealth.org/for-investigators/clinicians-proposal-submissions/ . I-SPY aims to make complete patient-level clinical datasets available for public access within 6 months of publication, as the data are complex and require significant annotation to ensure their usability.

Code availability

The statistical code used in this clinical trial is available to other investigators upon approval of the I-SPY Data Access and Publications Committee. Investigators interested in accessing the code may complete an application at https://www.quantumleaphealth.org/for-investigators/clinicians-proposal-submissions/ and include a brief description of the intended use. Access to the code may be granted upon approval of the request, subject to compliance with ethical guidelines and applicable institutional and regulatory requirements.

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Acknowledgements

Research reported in this paper was supported by the NCI of the National Institutes of Health (NIH) under award numbers P01CA210961 and U01CA225427 (to L.J.E. and N.M.H.). We acknowledge the generous support of the study sponsors and operations management, QLHC (2013 to present) and the Foundation for the NIH (2010 to 2012; to L.J.E.). We sincerely appreciate the ongoing support for the I-SPY2.2 trial from the Safeway Foundation, the William K. Bowes, Jr. Foundation, Give Breast Cancer the Boot and QLHC (all to L.J.E.) and the Breast Cancer Research Foundation (to L.J.E. and L.J.v.V.). We thank all the patients who volunteered to participate in I-SPY2. AstraZeneca provided funds and study drugs (datopotamab–deruxtecan and durvalumab). With the exception of QLHC, the funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. We thank D. Wolf and J. Gibbs and the I-SPY patient advocates for all their important contributions to this work.

Author information

These authors contributed equally: Rebecca A. Shatsky, Meghna S. Trivedi.

Authors and Affiliations

University of California San Diego, San Diego, CA, USA

Rebecca A. Shatsky, Anne M. Wallace, Kay Yeung & Sarah Boles

Columbia University, New York, NY, USA

Meghna S. Trivedi & Dawn L. Hershman

University of California San Francisco, San Francisco, CA, USA

Christina Yau, Hope S. Rugo, A. Jo Chien, Yunni Yi Chen, Laura Huppert, Wen Li, Natsuko Onishi, Adam L. Asare, Lamorna Brown-Swigart, Gillian L. Hirst, Jeffrey B. Matthews, Elissa Price, Diane Heditsian, Barbara LeStage, Laura J. van ’t Veer, Nola M. Hylton & Laura J. Esserman

University of Chicago, Chicago, IL, USA

Rita Nanda & Frederick M. Howard

North Carolina State University, Raleigh, NC, USA

Marie Davidian & Butch Tsiatis

University of Alabama at Birmingham, Birmingham, AL, USA

Erica Stringer-Reasor, Nusrat Jahan & Catherine Parker

The Mayo Clinic, Rochester, MN, USA

Judy C. Boughey & Karthik Giridhar

Cooperman Barnabas Medical Center, New Brunswick, NJ, USA

Coral Omene & M. Michele Blackwood

Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA

Coral Omene

Yale University, New Haven, CT, USA

Mariya Rozenblit & Tara Sanft

Emory University, Atlanta, GA, USA

Kevin Kalinsky

University of Colorado, Denver, CO, USA

Anthony D. Elias

University of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA

Christos Vaklavas

University of Minnesota, Minneapolis, MN, USA

Heather Beckwith & Douglas Yee

The Ohio State University, Columbus, OH, USA

Nicole Williams

University of California Davis, Davis, CA, USA

HOAG Family Cancer Institute, Newport Beach, CA, USA

Chaitali Nangia

University of Southern California, Los Angeles, CA, USA

Evanthia T. Roussos Torres

Sparrow Health System, Lansing, MI, USA

Brittani Thomas

Loyola University Chicago Stritch School of Medicine, Chicago, IL, USA

Kathy S. Albain

University of Pennsylvania, Philadelphia, PA, USA

Amy S. Clark & Angela DeMichele

University of Rochester Medical Center, Rochester, NY, USA

Carla Falkson

Lombardi Comprehensive Cancer Center Georgetown University, Washington, DC, USA

Claudine Isaacs

Wake Forest University, Winston-Salem, NC, USA

Alexandra Thomas & Brian Moore

City of Hope Orange County Lennar Foundation Cancer Center, Irvine, CA, USA

Jennifer Tseng

Sanford Health, Sioux Falls, SD, USA

Amy Sanford

Quantum Leap Healthcare Collaborative, San Francisco, CA, USA

Adam L. Asare, Philip Beineke & Peter Norwood

University of Texas MD Anderson Cancer Center, Houston, TX, USA

W. Fraser Symmans & Paula Pohlmann

The Gemini Group, Ann Arbor, MI, USA

Jane Perlmutter

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Contributions

Arm chaperone: R.A.S. and M.S.T. contributed equally to this work. Leadership: C.Y., H.S.R., R.N., B.M., J.P., P.P., A.D.M., D.Y., L.J.v.V., N.M.H. and L.J.E. Study design: C.Y., M.D., B. Tsiatis, A.D.M., D.Y., L.J.v.V., N.M.H. and L.J.E. Formal analysis: C.Y. and P.N. Enrolled patients: R.A.S., M.S.T., H.S.R., R.N., A.M.W., A.J.C., E.S.-R., J.C.B., C.O., M.R., K.K., A.D.E., C.V., H.B., N.W., M.A., C.N., E.T.R.T., B. Thomas, K.S.A., A.S.C., C.F., D.L.H., C.I., A.T., J.T., A.S., K.Y., S.B., Y.Y.C., L.H., N.J., C.P., K.G., F.M.H., M.M.B., T.S., A.D.M., D.Y. and L.J.E. Lab studies: L.B.-S., G.L.H. and L.J.v.V. Imaging/pathology: W.L., N.O., W.F.S. and N.M.H. Data management: A.L.A. and P.B. Administrative: G.L.H. and J.B.M. First draft: R.A.S., M.S.T., C.Y., P.N., J.B.M. and L.J.E. Editing and review: R.A.S., M.S.T., C.Y., H.S.R., R.N., M.D., B. Tsiatis, A.M.W., A.J.C., E.S.-R., J.C.B., C.O., M.R., K.K., A.D.E., C.V., H.B., N.W., M.A., C.N., E.T.R.T., B. Thomas, K.S.A., A.S.C., C.F., D.L.H., C.I., A.T., J.T., A.S., K.Y., S.B., Y.Y.C., L.H., N.J., C.P., K.G., F.M.H., M.M.B., T.S., W.L., N.O., A.L.A., P.B., P.N., L.B.-S., G.L.H., J.B.M., B.M., W.F.S., E.P., D.H., B.L.S., J.P., P.P., A.D.M., D.Y., L.J.v.V., N.M.H. and L.J.E.

Corresponding author

Correspondence to Laura J. Esserman .

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Competing interests.

R.A.S. reports institutional research funding from OBI Pharma, QLHC, AstraZeneca and Gilead; serves on AstraZeneca and Stemline Advisory Boards and Gilead Speaker’s Bureau; and has a consultancy role with QLHC. M.S.T. reports institutional research funding from Lilly, Gilead Sciences, Phoenix Molecular Designs, AstraZeneca, Regeneron, Merck and Novartis. C.Y. reports institutional research grant from NCI/NIH; salary support and travel reimbursement from QLHC; US patent titled, ‘Breast cancer response prediction subtypes’ (no. 18/174,491); and University of California Inventor Share. R.N. reports research funding from Arvinas, AstraZeneca, BMS, Corcept Therapeutics, Genentech/Roche, Gilead, GSK, Merck, Novartis, OBI Pharma, OncoSec, Pfizer, Relay, Seattle Genetics, Sun Pharma and Taiho Oncology and advisory roles with AstraZeneca, BeyondSpring, Daiichi Sankyo, Exact Sciences, Fujifilm, GE, Gilead, Guardant Health, Infinity, iTeos, Merck, Moderna, Novartis, OBI, OncoSec, Pfizer, Sanofi, Seagen and Stemline. H.S.R. reports institutional research support from AstraZeneca, Daiichi Sankyo, F. Hoffmann-La Roche AG/Genentech, Gilead Sciences, Lilly, Merck & Co., Novartis Pharmaceuticals Corporation, Pfizer, Stemline Therapeutics, OBI Pharma, Ambrx and Greenwich Pharma and has advisory and consulting roles with Chugai, Puma, Sanofi, Napo and Mylan. M.D. reports research grants from NIH/NCI and NIH/NIA, and contracts from PCORI. A.J.C. reports institutional research funding from Merck, Amgen, Puma, Seagen, Pfizer and Olema and has advisory roles with AstraZeneca and Genentech. E.S.-R. reports grants from V Foundation, NIH and Susan G. Komen; institutional research funding from GSK, Seagen, Pfizer and Lilly; and consulting and honoraria from Novartis, Merck, Seagen, AstraZeneca and Lilly; is a Cancer Awareness Network Board member and receives support from ASCO and NCCN. J.C.B. reports institutional research funding from Eli Lilly and SymBioSis, participation on the Data Safety Monitoring Committee of Cairn Surgical and honoraria from PER, PeerView, OncLive, EndoMag and UpToDate. C.O. reports consulting fees from AstraZeneca, Guardant Health and Jazz Pharmaceuticals. K.K. reports advisory and consultant roles for Eli Lilly, Pfizer, Novartis, AstraZeneca, Daiichi Sankyo, Puma, 4D Pharma, OncoSec, Immunomedics, Merck, Seagen, Mersana, Menarini Silicon Biosystems, Myovant, Takeda, Biotheranostics, Regor, Gilead, Prelude Therapeutics, RayzeBio, eFFECTOR Therapeutics and Cullinan Oncology and reports institutional research funding from Genentech/Roche, Novartis, Eli Lilly, AstraZeneca, Daiichi Sankyo and Ascentage. A.D.E. reports support from Scorpion, Infinity and Deciphera. C.V. reports institutional research funding from Pfizer, Seagen, H3 Biomedicine/Eisai, AstraZeneca and CytomX; research funding to their previous institution from Genentech, Roche, Pfizer, Incyte, Pharmacyclics, Novartis, TRACON Pharmaceuticals, Innocrin Pharmaceuticals, Zymeworks and H3 Biomedicine; advisory and consulting roles with Guidepoint, Novartis, Seagen, Daiichi Sankyo, AstraZeneca and Cardinal Health; unpaid consulting with Genentech; and participation in non-CME activity with Gilead and AstraZeneca. N.W. reports participation on Gilead’s Advisory Board and honoraria from OncLive, NCCN and Total Health Conferencing. K.S.A. reports institutional research funding from AstraZeneca, Daiichi Sankyo, Seattle Genetics, QLHC and the IDSM committee at Seattle Genetics. A.S.C. reports institutional research funding from Novartis and Lilly. C.F. reports honoraria from Curio Science and OncLive and institutional research funding from Eli Lily. C.I. reports institutional research funding from Tesaro/GSK, Seattle Genetics, Pfizer, AstraZeneca, BMS, Genentech, Novartis and Regeneron; consultancy roles with AstraZeneca, Genentech, Gilead, ION, Merck, Medscape, MJH Holdings, Novartis, Pfizer, Puma and Seagen; and royalties from Wolters Kluwer (UpToDate) and McGraw Hill (Goodman and Gilman). A.T. owns stock at Johnson & Johnson, Gilead, Bristol Myers Squibb; reports participation on Pfizer’s Advisory Board: AstraZeneca; reports institutional research funding from Merck and Sanofi; and has royalties from UpToDate. J.T. serves as institutional principal investigator for clinical trial with Intuitive Surgical and is the Editor Lead for ABS, CGSO, SCORE, Breast Education Committee Track Leader, ASCO SESAP 19 and Breast Co-Chair, ACS. K.Y. received research support unrelated to this work and paid to the institution from Pfizer, Gilead, Seagen, Dantari Pharmaceuticals, Treadwell Therapeutics and Relay Therapeutics and support from American Cancer Society IRG grant (no. IRG-19-230-48-IRG), UC San Diego Moores Cancer Center, Specialized Cancer Center support grant NIH/NCI (P30CA023100) and Curebound Discovery Award (2023, 2024). L.H. reports advisory and consultancy roles with Pfizer, and AstraZeneca. K.G. reports participation in advisory boards with honoraria to the institution from AstraZeneca, Novartis, Puma Biotechnologies, Eli Lilly, Gilead, Exact Sciences, NeoGenomics and TerSera Therapeutics. F.M.H. reports consultancy for Novartis. T.S. reports honoraria from Hologic. A.L.A., P.B. and P.N. are employees of QLHC. G.L.H. reports an institutional research grant from NIH (1R01CA255442). W.F.S. reports shares in IONIS Pharmaceuticals and Eiger Biopharmaceuticals; received consulting fees from AstraZeneca; is a cofounder with equity in Delphi Diagnostics; and issued patents for: (1) a method to calculate residual cancer burden, and (2) genomic signature to measure sensitivity to endocrine therapy. J.P. reports honoraria from Methods in Clinical Research (Faculty SCION Workshop) and support from ASCO and Advocate Scholarship; AACR (SSP Program); and VIVLI, U Wisc SPORE (EAB), QuantumLEAD (COVID DSMB), PCORI; is a reviewer; and is an I-SPY advocate lead. P.P. reports institutional research funding from Genentech/Roche, Fabre-Kramer, Advanced Cancer Therapeutics, Caris Centers of Excellence, Pfizer, Pieris Pharmaceuticals, Cascadian Therapeutics, Bolt, Byondis, Seagen, Orum Therapeutics and Carisma Therapeutics; consulting fees from Personalized Cancer Therapy, OncoPlex Diagnostics, Immunonet BioSciences, Pfizer, HERON, Puma Biotechnology, Sirtex, Caris Life Sciences, Juniper, Bolt Biotherapeutics and AbbVie; honoraria from Dava Oncology, OncLive/MJH Life Sciences, Frontiers (Publisher), SABCS and ASCO; Speakers’ Bureau: Genentech/Roche (past); and US patent no. 8,486,413, US patent no. 8,501,417, US patent no. 9,023,362 and US patent no. 9,745,377; and uncompensated roles with Pfizer, Seagen and Jazz. A.D.M. reports institutional research funding from Novartis, Pfizer, Genentech and NeoGenomics and is a program chair of the Scientific Advisory Committee, ASCO. D.Y. reports research funding from NIH/NCI: P30CA 077598, P01CA234228-01 and R01CA251600; consulting fees from Martell Diagnostics; and honoraria and travel for speaking at the ‘International Breast Cancer Conference’. L.J.v.V. is a founding advisor and shareholder of Exai Bio and is a part-time employee and owns stock in Agendia. N.M.H. reports institutional research funding from NIH. L.J.E. reports funding from Merck & Co., participation on an advisory board for Blue Cross Blue Shield, and personal fees from UpToDate and is an unpaid board member of QLHC. All other authors declare no competing interests.

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Shatsky, R.A., Trivedi, M.S., Yau, C. et al. Datopotamab–deruxtecan plus durvalumab in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial. Nat Med (2024). https://doi.org/10.1038/s41591-024-03267-1

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NIH Definition of a Clinical Trial

A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial. to one or more interventions interventions An "intervention" is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. health-related biomedical or behavioral outcomes. A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.   

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Baltimore County Police corporal acquitted on assault, use of force charges

Small executed a ‘textbook use of force,’ the officer’s attorney said.

A Baltimore County Police officer who pepper-sprayed a shackled and handcuffed man in the back of a patrol vehicle multiple times and later held him by the hair has been acquitted of second-degree assault and other charges, a judge ruled Wednesday.

Circuit Judge Paul E. Alpert issued his decision at the end of a seven-day bench trial for Cpl. Zachary Small, a 20-year veteran of the Baltimore County Police Department.

Read more coverage of the case against Baltimore County Police Cpl. Zachary Small

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Trial begins for Baltimore County cop accused of pepper spraying man in patrol car

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‘You asked for it’: Baltimore County cop accused of pepper spraying man in patrol car

The judge found the force that he used was reasonable under the circumstances.

Small, 52, testified that he used force against Justin Russell on Sept. 27, 2023, to gain compliance and carry out legitimate law enforcement objectives. The interaction was captured on multiple body cameras, which featured prominently in the trial. Small had been also charged with reckless endangerment, misconduct in office and violating Maryland’s Use of Force Statute.

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“We don’t believe this case should have ever been brought,” Small’s attorney, Brian Thompson, told The Baltimore Banner.

Russell had been convicted of armed robbery and armed carjacking, Thompson said. He had escaped from custody and had refused to cooperate, Thompson said.

Small executed a “textbook use of force,” Thompson said, warning Russell repeatedly and using de-escalation techniques. He tried to get Russell back in the car repeatedly and ultimately did so without injuring him, Thompson said.

Thompson also said there were 15 or so officers that were obligated to intervene if they saw improper use of force, Thompson said. None of them did, Thompson said.

“This is an officer with 20 plus years of experience who’s relying on his training and his instincts,” said Patrick Seidel, a defense attorney in the case. “And it turned out he was right.”

Baltimore County Police arrested Russell in Towson that morning but agreed to take him to Johns Hopkins Hospital to receive treatment for an unrelated gunshot injury to his hand. He escaped, but Baltimore Police a short time later recaptured him.

Law enforcement preparing to take him to the Woodlawn Precinct for booking and processing when he started banging on the inside of the patrol vehicle. Russell shouted through the window that the temperature inside the cruiser was too hot and later testified that he felt like he was going to die.

Small fired at least seven shots of pepper spray directly into his face, according to the indictment.

Body camera footage shows Small later pulled Russell out of the vehicle, threw him to the ground and then held him by his hair for about 30 seconds. That’s while Russell repeatedly asked for help and stated that he could not breathe.

Thompson said he expects Small’s suspension will be lifted but does not know yet when or if Small will return to the force.

”If he is going back after going through what he went through, I don’t know,” he said.

During closing arguments Wednesday, Assistant State’s Attorney Kimberly Rothwell asked the judge to “believe your own eyes” in viewing officers’ body camera footage.

“Some things are just common sense,” she said.

Rothwell argued Russell was already under police control — handcuffed, shackled and belted into the back of a police cruiser — when Small pepper-sprayed him inside of the vehicle while the windows were rolled up. She pointed to comments made by some of Small’s superior officers, who testified they did not believe he had acted according to county policy.

Russell testified that some of his hair was yanked from his scalp later during the exchange when Small had grabbed his locks and pulled his head back, a detail that Rothwell argued constituted serious injury. Russell was already complying with police directives, she said, when Small pulled him to his feet partially by grasping his hoodie.

Meanwhile, defense attorney Brian Thompson called the prosecution “political” and said Small shouldn’t have been charged at all. He called out city state’s attorneys for stopping short of prosecuting officers in their own jurisdiction. City Sgt. Christopher Mumey was the highest-ranking officer on the scene, Thompson said, but was not charged for failing to intervene as three other Baltimore County officers were.

Defense attorneys argued Small’s actions were in line with county police training and included several warnings as de-escalation tactics. Russell had already escaped custody once, they said, and posed a safety risk to himself and to officers. His claims about not being able to breathe were a lie, they said.

The defense played audio from a phone call Russell allegedly placed from jail in the days following the incident. In the recording Russell could be heard saying he “would have straight popped him and got out of there, but it would have been a man hunt for me.” The audio was referenced during the trial but played for the first time during closing arguments.

Small’s superior officers did not review all available body camera footage before they determined his actions were inappropriate, Thompson said. Russell had failed to comply with orders, was physically aggressive and posed a risk of destruction to the police cruiser when he banged on the glass, he said.

The defense also pointed to a moment captured on camera later at the county precinct. An officer asked Russell whether he had any major health complaints beside the pepper spray. Russell replied no and mentioned an older injury to his hand from an unrelated gunshot wound.

Three other Baltimore County police officers, Justin Graham-Moore, Jacob Roos and Thomas Desmond, remain charged with misconduct in office.

They’re accused of failing to intervene as required under the Maryland Police Accountability Act of 2021, a reform passed in the wake of the murder of George Floyd that requires officers to “prevent or terminate” a use of force beyond what’s authorized under the law. The provision went into effect on July 1, 2022.

Baltimore Banner reporter Dylan Segelbaum contributed to this report.

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What is a Trial Brief and can I see a sample?

Below is an example of a Trial Brief, an external document that paralegals create. You can also click on the sample at the bottom of the page.

Sample Trial Brief

The top of the Trial Brief needs to include the case style. The case style identifies the relevant information about the case such as the court’s name, the names of the parties, the docket number or case number that was assigned by the clerk of court, and the title of the document. For example:

IN THE CIRCUIT COURT OF THE FIRST JUDICIAL CIRCUIT

IN AND FOR JOHNSON COUNTY, ALABAMA

IN RE: THE MARRIAGE OF                                    CASE NO.: 12-1234-DR-001234

JOHN DOE,                                                                DIVISION: Family

            Husband,

            Wife.

______________________________/

PETITIONER/HUSBAND’S TRIAL BRIEF

• INTRODUCTORY STATEMENT

The party filing the Trial Brief would make a brief introductory statement simply stating why the Trial Brief is being filed.

• QUESTION(S) PRESENTED: ISSUES(S)

This section will address the legal issue(s) in the brief. The issue is the legal question to be answered by the court. The issue should include the rule of law (which law applies, how a law applies, or whether a law applies), the legal question, and the key facts. When you are reading the issue, ask yourself, “What legal question, about what law, involving what facts, is being argued about in the case?” If you have more than one issue, make sure you list them in the same order that you will discuss them in your argument section.

• STATEMENT OF FACTS

In order to save the judge time reading all the pleadings filed in a case to determine what the case is about, include a statement of facts. Make your client look favorable by using descriptive words to emphasize the facts that support your position. If you are stating facts that are not favorable to your client, word them in such a way that is less noticeable. You can present the facts in chronological order or by topic. Do not argue your case in this section. You will argue the case later in the Trial Brief. You can use your client’s name when stating the facts. Present your client in a way that will help the judge begin to form good impressions and draw conclusions about your client. Win the judge over!

The argument section of the Trial Brief is the most important section. This is where you analyze the law that supports your client’s position and describe why and how the law supports the position of your client.

When presenting the cases and statutes to make your argument, make sure the favorable cases and statutes stand out and discuss how they apply to your client’s case. You also should include the unfavorable cases and statutes showing why they are different and how they should not apply to your client’s case.

Do not just summarize your cases and statutes. Analyze and apply them to your client’s case so the judge will see how the cases should be used to rule in your client’s favor. If you use the I ssue, R ule, A nalysis/Application, and C onclusion (IRAC) approach, you will be sure you are analyzing the issue. For example:

• Issue – identify the issue(s) raised by the facts of the client’s case
• Rule – identify the law(s) that controls the issue(s)
• Analysis – how does the rule of law apply to the issue(s)
• Conclusion – a summary of the legal analysis

Case Law (if needed)

Application of the law to the issue being addressed

Discussion of the opposing party’s position

• You can use Roman numerals or other identifying numbering.
• You may center the header on the page or left justify it.
• The Trial Brief is a persuasive document; attempt to make even your headers persuasive.
• If you need to, you can also use subheadings; these usually use capital letters of the alphabet for identification.
• Your citations should also appear in the body of the Trial Brief. Use The Bluebook method of citation.
• Never use first person when writing.
• Focus on the parties, referring to them by name or using their titles, such as husband or wife.

The conclusion section of your Trial Brief is a request for what action you want the judge to take. This section should be very brief. Summarize the highlights of your argument. You do not have to include any citations in this section. At the very end, reiterate what you are asking the court to do. This section could be as short as one sentence, but no more than a half a page .

• SIGNATURE AND DATE

The end of your brief is similar to what you would see at the end of a letter. For example:

                                                                                    Respectfully submitted,

Dated: ____________________                                ____________________________________

                                                                                    Attorney So and So

                                                                                    Attorneys for (Husband or Wife)

                                                                                    Name of Husband or Wife

                                                                                    Attorney’s Street Address

                                                                                    Attorney’s City, State and Zip

                                                                                    Attorney’s Bar No.:

CERTIFICATE OF SERVICE

Anytime you file anything with the court, you must verify that all parties have received copies. The Certificate of Service is placed at the very end of a pleading and states that a copy has been served on all parties. You must also include how it was served, such as by mail, efiling portal, email, or by hand delivery. For example:

            I HEREBY CERTIFY that the foregoing document was served via (U.S. Mail, hand delivery, through the efiling portal, or email) to the attorney for the (Wife or Husband), attorney’s name, attorney’s address, attorney’s email, this ____ day of Month, Year.

You may want to include exhibits for the court to review, such as deposition transcripts, answers to interrogatories, affidavits, and other documents. Fully describe each exhibit within your Trial Brief and then labeled at the end of the brief. Never insert exhibits in the middle of your Trial Brief. 

Links & Files

• Trial_Brief_FAQ_2020.docx
• Justice Studies and Paralegal Studies
• Last Updated May 28, 2020
• Views 53842
• Answered By Kerry Louvier

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