Advancing the Quality of Clinical Trial Enterprise

Advancing the Quality of Clinical Trial Enterprise

Evidence that substantial numbers of trials do not contribute meaningful information to the evidence base raises both ethical and scientific concerns. Participants assume the risks and burdens of a study, while mistakenly believing that they are contributing to medical progress. At the same time, these non-informative trials divert participants, researchers, and other resources from more valuable trials, potentially making it more difficult to reach enrollment targets.

Although others have identified the conduct of non-informative trials as a significant problem, there has been less progress in defining, studying, and attempting to reduce their frequency and thus improve the quality of the medical evidence base. This program focuses on efforts to improve the efficiency and quality of clinical trials, with the overall objective of optimizing the impact of each trial participant and informing key medical and policy decisions. In addition, we build on the established foundation of trial reporting to ClinicalTrials.gov with the aims of improving the timeliness and quality of reports, as well as increasing the use of data from ClinicalTrials.gov by the research enterprise.

Objectives

Develop “best practices” for the conduct of landscape analyses that enable researchers and other oversight entities to understand what is already known, and what is currently being investigated, about their research question
Analyze large samples of informed consent forms in order to establish better (and worse) practices, and to start to develop tools that might help researchers to write future consent forms
Increase use of data from ClinicalTrials.gov to inform research decisions

key Milestones

April 2023: Co-authored article “How to limit uninfomative trials: Results from a Delphi working group”
April 2022: Co-authored article “Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis”
February 2022: Co-authored article “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing”
November 2021: Co-authored article “Characterization of Informed Consent Forms Posted on ClinicalTrials.gov”
October 2021: Co-authored article “Monitoring the Pediatric Clinical Trials Enterprise”
May 2021: Co-authored article “Trial Reporting and the Clinical Trials Enterprise”
April 2021: Served on NASEM committee which released a report on genomic epidemiology data infrastructure; co-authored article “Lack of harmonization of coronavirus disease ordinal scales”
January 2021: Contributed to article “Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response”
December 2020: Co-authored letter to the editor “Lack of harmonization of coronavirus disease ordinal scales”
April 2020: Co-authored white paper “Diagnostic Testing for COVID-19 Considering False Positive and False Negative Results”
March 2020: Co-authored article “Time for NIH to lead on data sharing”
January 2020: Co-authored article “Issues in the registration of database studies”

Project leadership & STAFF

Deborah Zarin, MD, Program Director, Advancing the Clinical Trial Enterprise, MRCT Center
Barbara E. Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center

Project Resources

Training & Education

TRAINING MODULES

MRCT Center Virtual Training

View all MRCT Center virtual training modules here:

Training Modules

Training & Education

The skills and experience of investigators and study staff, research ethics boards, and regulators vary widely across the globe. To meet the demands of the changing regulatory and ethics landscape, regulators, ethics committees, Investigators, and site staff need continuous learning and discussion of emerging issues in clinical research. Training and capacity building is one of the core strengths of the MRCT Center.

Long-standing history in capacity building

The MRCT Center has a long-standing history of developing ethics and regulatory skills in both high and low- and middle-income countries. The MRCT Center has been endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as a training associate and designated as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence. Over the past decade, our capacity building efforts have trained more than 10,000 participants from over 100 countries and spanned from data monitoring committees, pharmacovigilance and safety, clinical research professional competency, good clinical practice and multi-regional clinical trials, to research ethics.

Approach to capacity building and training

Since 2020, the MRCT Center has leveraged technical capabilities to develop both virtual and sustainable online training.

In-person or in-country training: in-person / in-country dynamic training using a training model in which we partner with a local collaborator (e.g., academic leader, regulator, institution) to identify the appropriate topics that are of highest need and select the trainees for the course

Online, recorded training modules: available free of charge on an MRCT Center portal within the Mass General Brigham Office of Continuing Professional Development website.

Virtual training: live, interactive training sessions delivered virtually, in collaboration with an in-country partner

View all MRCT Center virtual training modules HERE

Areas of Expertise:

The MRCT Center has expertise in the following areas:

ICH Guidelines: As a Training Associate of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the MRCT Center is working with ICH to develop a series of training modules:
- General Considerations for Clinical Trials E8(R1): The E8(R1) Introductory Overview Video is available on the ICH Training Library website. A series of in-depth training modules for ICH E8(R1) with case studies and interactive learning activities is in development.
- Good Clinical Practice E6(R3): The MRCT Center is working closely with the E6(R3) Expert Working Group (EWG) to develop a series of in-depth training modules for the revised Good Clinical Practice (GCP) guidelines. The first set of modules will be released in mid-2025.
- General Principles for Planning and Design of Multi-Regional Clinical Trials E17: A landscape analysis of implementation issues with ICH E17 is in development.
Clinical Research and Ethics: The MRCT Center is building capacity for research ethics committees (RECs) across Africa and worldwide. Our work aims to harmonize the clinical trial application review process and build a robust, competent, and efficient system for the ethics review of clinical research. The online, on-demand training course entitled “Ethics and Review of Interventional Clinical Research” is freely available on the WHO Academy. Development for the second course in the series “Ethics and Review of Interventional Clinical Research” is ongoing and anticipated to be available in the fall of 2025.
Clinical Research Design and Conduct: The MRCT Center designed a curriculum to introduce the audience to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real-world evidence. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local regional context. Example: Virtual clinical research training in Indonesia.
Data Monitoring Committee Training: Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program to engage motivated individuals to become Data Monitoring Committee (DMC) champions within their home country and to participate in DMCs for multi-regional clinical trials. Example: Virtual DSMC Training in the Philippines.
Health Literacy: Online, virtual, and in-person capacity building activities provide research professionals with practical guidance and tools to integrate health literacy best practices into their roles. For Example: IRB Health Literacy in Clinical Research online training.
Representation in Clinical Research: The MRCT Center training is intended to aid attendees in improving their ability to enroll underrepresented participants in clinical research and develop mechanisms for ongoing sustainability of representative populations in clinical research. For more information: Equity by Design 6-part virtual training course.
Causality Training: This training enables clinicians and ethics committee members to follow best practice procedures in determining causality for participant injuries or illnesses occurring in the course of a clinical trial. Example: Causality Assessment Workshop in Gurgeon, India.

OBJECTIVES

Improve regulatory capacity to provide a unified standard for conducting and oversight of clinical trials
Improve capacity of those planning and reviewing clinical trials to conduct effective multi-regional trials
Improve capacity of those planning, reviewing, and conducting clinical trials to ultimately lead to participant safety

project Leadership & sTAFF

Barbara Bierer, MD. Faculty Director, MRCT Center
Sarah White, MPH. Executive Director, MRCT Center
Carmen Aldinger, PhD, MPH, PMP. Senior Administrative and Training Manager, MRCT Center
Chloe de Campos, BS. Graphics and Information Design Specialist, MRCT Center
Lauren Otterman, MBE. Project Manager, MRCT Center

Project Resources

Impact of Privacy Laws on Clinical Research

Impact of Privacy Laws on Clinical Research

The MRCT Center remains at the forefront of analyzing and understanding the impact of the GDPR and other privacy laws that impact clinical research data and biospecimen sharing. The patchwork of privacy laws that apply to the processing of personal data and in some cases restrict the transfer of such data across national boundaries impedes the progress of science and public health and the use of personal data for secondary research.

The European Union’s General Data Protection Regulation (GDPR) took effect on May 25, 2018. The regulation governs the processing of personal data of individuals located in any member state of the European Economic Area (EEA) or personal data processed in the context of an entity’s establishment located in an EEA member state. Following “Brexit,” the United Kingdom has enacted national legislation, commonly referred to as the UK GDPR, that is substantially similar to GDPR. Under both GDPR and UK GDPR, personal data are defined broadly as “any information relating to an identified or identifiable natural person (“data subject”); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural, or social identity of that natural person. The GDPR had an immediate impact on clinical research generally and multi-regional clinical trials specifically.

In addition to the GDPR, recent years have seen a growing number of sector-specific and omnibus state privacy laws in the U.S., such as the CCPA/CPRA and recently-passed data privacy legislation in Colorado, Utah and Virginia, as well as Florida’s Protecting DNA Privacy Act. Also of note, China enacted an omnibus data privacy law known as the Personal Information Protection Law (“PIPL”), which took effect in 2021, Brazil’s General Data Protection Law (“LGPD”) became subject to enforcement in 2021, and India’s Digital Personal Data Protection Act (“DPDP Act”) was enacted in 2023. The MRCT Center continues to monitor the development of these laws and suggests strategies to help the research community comply with such laws, including through advocacy with relevant public authorities and industry stakeholders.

Contact Information: mrct@bwh.harvard.edu

objectives

Identify, explain, and discuss key problems that the GDPR and other privacy laws have introduced for the for the domestic and global research community on clinical research, biobanking, and data banking, as well as big data research.
Highlight the major challenges and ambiguities that privacy laws present for regulators, industry, academia, IRBs/research ethics committees, and researchers.
Engage with the European Commission and EDPB to explore potential solutions.
Share preferred operational practices in each of these areas.
Identify where further guidance or explanations (e.g., FAQs) would be helpful.

key milestones

November 2024: MRCT Center submitted public comments to the U.S. Department of Justice’s proposed rule “Provisions pertaining to preventing access to U.S. sensitive personal data and government-related data by countries of concern or covered persons”
October 2024: MRCT Center Research, Development, & Regulatory Roundtable discussed limitations on sharing data with China and other countries of concern
December 2023: MRCT Center Research, Development, & Regulatory Roundtable discussed developments over the past year, including adoption of the EU-US Data Privacy Framework
During 2023: Convened experts in the field to assess the ongoing and evolving impact of privacy laws on clinical research and data sharing
December 2022: MRCT Center Research, Development, & Regulatory Roundtable hosted a one-day conference on GDPR and privacy laws in other geographies (China, India, Japan, and South Africa). Dr. Francis Collins, Senior Advisor to the President (Acting) and Former Director of the National Institutes of Health, delivered the keynote address. The five sessions included panelists from academia, pharmaceutical companies, and regulatory bodies.
February 2022: MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy”
October 2021: Co-authored “Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data,” Journal of Law and the Biosciences
September 2021: MRCT Center comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
April 2021: MRCT Center comments in response to European Data Protection Board questions on research and GDPR.
October 2020: Co-authored an article in Science Magazine entitled “How to Fix the GDPR’s Frustration of Global Biomedical Research.” The article received significant attention and has been provided as a briefing material to members of the Biden administration seeking to understand international data sharing issues.
May 2020: David Peloquin participated in a webinar organized by ISC that was a follow-up to the November 2019 Brussels conference and discussed the MRCT Center’s comments submitted to the European Commission in April 2020.
April 2020: MRCT Center submitted comments to the European Commission outlining the challenges that GDPR has created for the research community along with potential solutions in response to the European Commission’s call for comments on GDPR.
March 2020: Co-authored an article in the European Journal of Human Genetics entitled “Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data” discussing the challenges of GDPR for secondary research and biobanking activities.
November 2019: MRCT Center and Ropes & Gray LLP co-organized ISC Seminar on Challenges for Health Research arising from GDPR in Brussels, Belgium.
May 2019: Mark Barnes attended a meeting with the Irish Data Protection Commission to discuss the challenges the GDPR poses to the research community.
February 2019: Mark Barnes and colleagues at Ropes & Gray co-authored an article discussing the challenges in the EDPB’s February 2019 opinion on the intersection of the GDPR and the EU Clinical Trials Regulation.
January 2019: MRCT Center sent a letter to the EDPB commenting on the EDPB’s November 2018 draft guidance on the territorial scope of the GDPR.
July 30, 2018: Application of the GDPR to Research: Legal, Practical and Strategic Implications: The MRCT Center convened over 110 representatives from academia, industry, and government. The conference explored the impact of the EU GDPR on human subjects’ research, biobanking and data banking, and big data research. A letter summarizing the findings was sent to the European Commission Directorate-General for Research and Innovation with a copy to EMA, NIH, and others.

PRoject leadership & Staff

Mark Barnes, JD, LLM, Faculty Co-Director, MRCT Center
Barbara E. Bierer, MD, Faculty Director, MRCT Center
David Peloquin, JD, Ropes & Gray LLP

Project Resources

Proactive Safety Surveillance: A Global Approach

Proactive Safety Surveillance: A Global Approach

Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders. Safety data are collected and analyzed not only throughout product development but also after approval, through analysis of observational data and/or designated studies. Post-market surveillance more closely represents the real-world setting, and some adverse events only manifest after regulatory approval and adoption as a result of wider dissemination to patients.

Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. A limited number of surveillance systems have utilized innovative analytical and statistical techniques, including data mining, machine learning and artificial intelligence to interrogate real-world data. While these approaches are important and complementary, they fail to harness the full power of cooperation across stakeholders and systems to realize global inclusivity in safety surveillance.

Convened by the MRCT Center in collaboration with others, the Proactive Safety Surveillance initiative (PSS) aims to improve upon current safety surveillance systems by creating a global, cooperative model for a more proactive, predictive safety surveillance system. A partnership with expert stakeholders will aid the selection, evaluation, and adaptation of new technologies, methodologies, and insights to support the medical determination and validity of safety signals. Such a system would also highlight the importance of a thorough benefit and risk analysis and provide better data for the global community. While inevitably challenging, we believe exploration of such a system holds the promise of increasing the timely detection, validation, and communication of important safety information.

OBJECTIVES

Create a framework for an international approach to proactive drug and device safety surveillance, validation, and communication
Engage diverse and international representatives to examine the ethical, social, and political challenges of a global, proactive safety surveillance system
Develop a governance model for the initiative that is respectful of sovereign authorities and differing international laws and regulations
Develop one or more examples of pilot projects appropriate to test the advantages and limitations of a global proactive safety surveillance system

Key Milestones

December 2019: Core Team Conference
September 2019: Methodological Comparison Meeting
May 2019: Visioning Session
Jan – April 2019: Project Core Team established

Program Leadership & STAFF

Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
Paul Bleicher, MD, PhD, Principal, Evident Health Strategies
Paul Chang, MD, Chief Safety Officer, Johnson & Johnson
William Crown, PhD, Distinguished Research Scientist, Brandeis University
David Madigan, PhD, Provost and Senior Vice President for Academic Affairs, Northeastern University
Sandra Morris, PhD, Vice President Strategy Realization, Johnson & Johnson
Frank Rockhold, PhD, Professor, Duke University
Joseph Ross, MD, Associate Professor of Medicine, Yale School of Medicine
Patrick Ryan, PhD, Vice President of Observational Health Data Analytics, Janssen Research and Development
Jodi Segal, MD, Professor, Johns Hopkins School of Medicine
Paul Stang, PhD, Vice-President Global Epidemiology, Johnson & Johnson
Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson
Sarah White, MPH, Executive Director, MRCT Center

Project Resources

Promoting Global Clinical Research in Children

Promoting Global Clinical Research in Children

Critical to the health of a population is the development and administration of safe and effective therapeutic products for children. Global innovation in pediatric drug development lags behind adult product development due to myriad practical challenges of executing multi-national clinical trials, regulatory challenges of working across jurisdictions, and ethical challenges of enrolling children in research. As a consequence, pediatric patients are often prescribed therapeutic products for which safety or efficacy information for those age groups and/or those indications is inadequate.

Medicines—including drugs, biologics and devices—must be more frequently, rigorously, and carefully evaluated for safety and efficacy in the global pediatric population. This vision depends, in part, on identifying and overcoming existing barriers to conducting multi-regional pediatric trials, and then motivating their enrollment, conduct, and completion.

In pursuit of the goal to further harmonize approaches and offer tools to regulate and facilitate pediatric research around the globe, the MRCT Center convened a workgroup in 2019 of diverse stakeholders from academia, industry, regulatory agencies, not-for-profit organizations, trial networks, patients and patient advocacy organizations, and existing pediatric research initiatives. With our workgroup activities now complete, we are focused on disseminating our findings and continuing to actively engage in various international projects.

We offer a comprehensive suite of resources tailored for stakeholders who are directly involved or have an interest in pediatric clinical research. This includes our Including Young People in Research toolkit, our Guiding Principles, and a curated selection of pediatric-focused webinars, complete with recordings and summaries.

In 2024, we released a comprehensive interactive webpage to summarize the work and link to key deliverables.

Objectives

To identify the challenges related to decision making for individual children that impede the conduct of transnational pediatric clinical trials, including issues related to assent, consent, and inclusion of the voice of young people.
To address the lack of consensus and awareness on key issues around benefit and risk considerations that create barriers to and inefficiencies in transnational research with children.
To define and address the operational barriers to conducting transnational pediatric trials and propose solutions, including the promotion of a model of global pediatric regulatory cooperation.

Key Milestones

November 2024: Published Engaging children and adolescents in the design and conduct of paediatric research
October 2024: Successfully hosted a 2-day workshop, “Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact,” in Washington, DC
January 2024: A comprehensive interactive overview of the Pediatrics project and key deliverables was released.
March 2023: Released the Including Young People in Research toolkit.
March 2023: Hosted the fifth in the 5-part webinar series, Informing the Future.
November 2022: Hosted the fourth in the 5-part webinar series, Facilitating Pediatric Medicines Development: Models of Global Cooperation
June 2022: Hosted the third in the 5-part webinar series, Assent and Consent in the Field: Culture, Context, and Respect
April 2022: Release of 3 additional pediatric educational brochures for young people contemplating participation in a clinical trial; these proudly carry the iCAN Seal of Approval
February 2022: Hosted the second in the 5-part webinar series, Time to Listen: Hearing from Young People in Clinical Research
October 2021: Hosted the first in the 5-part webinar series, Advancing international Pediatric Clinical Research: Informing the future form COVID-19 Lessons Learned.
July 2021: Panel discussion at DIA-Pediatric engagement in research: Young people have a voice
March 2021: Dissemination of “Biobank” comic book, a collaboration of Boston Children’s Hospital, Harvard Catalyst and Precision Link
February 2021: Project focus pivots to deliverable preparation
January 2021: Received an FDA R13 scientific conference grant to support a series of meetings, “Global Cooperation to Promote Clinical Research in Children” to be hosted virtually during 2021-2022
December 2020: Panel Discussion at MRCT Center Annual Meeting–Emerging Issues in Global Pediatric Clinical Trials: Perspectives on patient/family/caregiver engagement
November 2020: Released “Assent to Consent” flyer which earned the iCAN (International Children’s Advisory Network) “Seal of Approval”
January 2020: Core leadership team in-person meetings
October 2019: Project launch with first work group meeting of diverse stakeholders

Project Leadership & Staff

Barbara E. Bierer, MD. Faculty Director, MRCT Center
Steven Joffe, MD, MPH. Chief, Division of Medical Ethics, Perelman School of Medicine at the University of Pennsylvania
Dominik Karres, MD, CPM. Paediatric Medicines Office, Scientific Evidence Generation Department, European Medicines Agency
Robert “Skip” Nelson, MD, PhD. Senior Director, Pediatric Drug Development, Johnson & Johnson
Lisa Koppelman, MSW, LICSW, MPH. Program and Team Director, MRCT Center
Trevor Baker, MS. Program Manager, MRCT Center
Lauren Otterman, MBHL. Project Manager, MRCT Center
Ava Glazier, MPH Candidate. Research Assistant, MRCT Center

Project Resources

Real World Evidence

Real World Evidence

Derived from data sources such as electronic health records, claims data, registries, and mobile devices, real world evidence (RWE) has the potential to bring innovative products to patients more quickly. Unlike randomized controlled trials (RCTs), which may not be representative of a general population due to strict inclusion and exclusion criteria, RWE may more closely identify how an investigational product will perform in a general population. To address the absence of widely accepted best practices for utilizing RWE, the MRCT Center collaborated with Duke-Margolis Center for Health Policy to define a framework to establish best practices for utilizing RWE for regulatory decision-making.

The MRCT Center also worked with OptumLabs to investigate sources of variability in RWE analysis as applied to replication (emulation) of RCTs. Conceptualized by the MRCT Center and OptumLabs, the Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) Project aimed to understand the sources of variation in design, approach, methodologies, statistical analyses, and decision-making using real world evidence (RWE, specifically claims and EHR data) to emulate phase 3 clinical trials. First, RWE is used to replicate published clinical trials, using and analyzing data limited explicitly to the eligibility criteria of the trial. Later, the aperture of inclusion is broadened to determine any change in effect size by the broader population.

The OPERAND project convened a technical expert panel (TEP) comprising key stakeholders from industry, academia, and regulators, to consider the principles behind, the methodology to draw upon, and the appropriate utilization of, observational data in regulatory review and approval and comparative effectiveness research.

Brown University and Harvard Pilgrim Health Institute, were selected to replicate two trials:

(1) the ROCKET trial for atrial fibrillation, a multicenter, randomized, double-blind, double-dummy, event-driven trial that was conducted at 1178 participating sites in 45 countries) and
(2) the Lead-2 trial for Type 2 Diabetes control, a multi-center, randomized, double-blind, parallel assignment of 1091 participants conducted at 190 study sites across 4 continents).

The project helped validate the use of observational data to complement evidence from RCTs and used empirical data to understand methodologies and sources of variability.

Objectives

To develop empirical data to understand data quality – and the limitations of RWD – from various data sources (e.g., Claims, EHR) and the assumptions necessary to use such data for replication
To determine whether and how the addition of EHR to Claims data improves sensitivity and utility of data, and thus RWE utility
Following replication, to determine how RWE informs understanding of effectiveness for on-label indications in approved populations
To advance regulatory decision-making through RWE

key milestones

February 2021: Presentation about OPERAND at FDA/Duke Margolis virtual workshop Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses
January 2021: With William Crown, co-authored Real-World Evidence: Understanding Sources of Variability Through Empirical Analysis, in Value in Health
December 2019: Duke-Margolis released Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
November 2019: Duke Margolis released Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
September 2019: Duke-Margolis released Determining Real-World Data’s Fitness for Use and The Role of Reliability
June 2019: Grants announced for two academic institutions to replicate two clinical trials using real world data
August 2017: Launched Project OPERAND and held first conference call with the Technical Expert Panel (TEP)
March 2017: Started collaborating with Duke-Margolis Center for Health Policy to develop a framework for real world evidence for regulatory decision-making

Project leadership & Staff

Barbara Bierer, MD. Faculty Director, MRCT Center
William Crown, PhD. Chief Scientific Officer, Brandeis University (formerly Optum Labs)
Hayat Ahmed, MSc., Program Manager

Project Resources

For Patients and Participants

Patients & Participants Resources

The MRCT Center has developed resources with, and for, patients and participants.

Resources for the community of patients, participants and caregivers include:

A Participant Bill of Rights
Research Information for Young People
A Clinical Research Glossary to explain research concepts in plain language
Information to Guide Decision Making Around Receiving Individual Research Results
A Tool for Figuring out Research Costs and Payments
Covid-19 flyers to introduce research within the context of the pandemic
Toolkit “Including Young People in Research“

The MRCT Center welcomes patients, participants, advocates, and family members who have experience related to clinical trials to volunteer in our workgroups and towards our efforts. Please contact MRCT@bwh.harvard.edu. Please include a few sentences about your experience in clinical research.

Participant Bill of Rights

For people who want to learn more about what to expect when deciding whether to join a clinical research study.

LEARN MORE

Research Information for Young People

Informative brochures explaining clinical research and a series of International Children’s Advisory Network (iCAN) videos featuring young people from all over the world sharing their experiences of participating in clinical research.

Time to Listen: Hearing from Young People in Clinical Research – PART 2 ›

In a proof of concept concluding video, the same 3 young people watch excepts of adults presenting at an international webinar on elevating the voices of […]

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Assent to Consent ›

This brochure explains what happens when a child participating in research becomes a legal adult and is asked to consent to continue participation.

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What Happens at the End of a Research Study? ›

This brochure explains what happens after your last study visit with researchers and how they might use information they collected from you.

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What is Clinical Research? ›

This brochure defines clinical research and the difference between research and medical care.

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Sharing Your Information (Data) In Research ›

This brochure explains what data is and how researchers use your data in a study.

Learn More ›

What is Assent? ›

This brochure defines assent and what young people should consider before providing research assent.

Learn More ›

What Is a Focus Group & Why Should I Join One? ›

This brochure explains what a focus group is and what you can expect if you join one.

Learn More ›

Sensitive Information In Research ›

This brochure explains why researchers might ask you questions about sensitive topics and how they protect your privacy.

Learn More ›

Prioritizing Young People’s Voices in Clinical Research Part 1 ›

Youth share their experiences receiving medical care and healthcare, and express what they believe researchers should ask young people about clinical […]

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Prioritizing Young People’s Voices in Clinical Research Part 2 ›

Youth share their preferences on what doctors have communicated to and with them, and on decision making related to participation in clinical research.

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Prioritizing Young People’s Voices in Clinical Research Part 3 ›

Youth share what they believe researchers should tell young people about clinical trials and research. They further share their ideas on what motivates […]

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Time to listen: Hearing from Young People in Clinical Research – Part 1 ›

Young people share their experience in clinical research, including: what it is like when a doctor or researcher talks to them as a child […]

Learn More ›

Clinical Research Glossary

Learn more about words commonly used in
clinical research.

EXPLORE GLOSSARY

Individual Return of Results

A guide to help participants decide if they wish to receive individual results from a research study.

LEARN MORE

Costs and Payments

A list of questions for patients, participants and caregivers to ask study teams about research study costs and payments.

LEARN MORE

“Including Young People in Research” Toolkit

A toolkit to facilitate and support those wishing to engage and include children and adolescents in research and research-related activities.

VIEW TOOLKIT

Advancing the Quality of Clinical Trial Enterprise

Objectives

key Milestones

Project leadership & STAFF

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TRAINING MODULES

MRCT Center Virtual Training

Training & Education

OBJECTIVES

project Leadership & sTAFF

Project Resources

Training

Training

Public Comments

Proceedings

MRCT Sponsor Resource

Presentation

Training

Training

Annual Report

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MRCT Sponsor Resource