Resources

• Publication

Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions

• Publication

An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity

• Publication

Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct

• Publication

Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions

• Public Comments

Draft Guidance: Considerations for Including Biopsies in Clinical Trials

• Public Comments

Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

• Public Comments

Public Comments submitted: “Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons”

• Publication

Declaration of Helsinki – Revisions for the 21st century

• Public Comments

Public Comments submitted: “Request for Information on the National Institutes of Health Draft Public Access Policy”

• Publication

The PubPeer conundrum: Administrative challenges in research misconduct proceedings

• Public Comments

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

• Public Comments

Public Comments submitted: “Declaration of Helsinki Public Comment Period Two”

• Publication

The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, by Carl Elliott. New York: W.W. Norton & Company, 2024

• Publication

Proposed Increases in Government Authority Over Research Misconduct Proceedings

• Public Comments

Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

• Public Comments

Public Comments on Declaration of Helsinki: Phase 1

• Publication

Deprioritization of Ongoing Clinical Trials

• Publication

Defining “recklessness” in research misconduct proceedings

• Publication

The Unresolved Challenge of Triage

• Publication

Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research 

• Publication

Bringing data monitoring committee charters into the sunlight

• Publication

Returning Individual Research Results from Digital Phenotyping in Psychiatry

• Publication

Data sharing in the context of community-engaged research partnerships

• Publication

Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

• Publication

Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials

• Publication

Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed

• Publication

Ensuring the Scientific Value and Feasibility of Clinical Trials

• Annual Report

2022 MRCT Center Annual Report

• Publication

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies

• Proceedings

MRCT Center 2022 Annual Meeting Proceedings

• MRCT Sponsor Resource
• Presentation

MRCT Center 2022 Annual Meeting Slides

• Publication

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

• Publication

Ethical Challenges in Clinical Research During the COVID-19 Pandemic

• Publication

Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinate multinational study

• Publication

The proportion of randomized controlled trials that inform clinical practice

• Publication

Approach For Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis

• Meeting Summary

Limited English Proficiency and Translation of Study Materials

• Presentation

Big Ideas and Ethics in the Big Easy

• Publication

Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis, published in Clinical and Translational Report

• Presentation

Future of Clinical Trial Data Sharing Slides Day 1

• Publication

Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing in Clinical Therapeutics

• Public Comments

The MRCT Center Submitted Public Comments to the National Institutes of Health (NIH)

• Podcast

Drug Researchers Refuse To Follow The Law. The Government Isn’t Stopping Them

• Publication

Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response

• Annual Report

2021 MRCT Center Impact Report

• Publication

Demystifying Schrems II for the cross-border transfer of clinical research data

• Public Comments

MRCT Center submits comments to National Institutes of Health (NIH) on Developing Consent Language for Future Use of Data and Biospecimens

• Publication

Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov

• Publication

Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

• Publication

Navigating the ethics of remote research data collection

• Publication

Online Research Participant Communication: Balancing Benefits and Risks

• Publication

Trial Reporting and the Clinical Trials Enterprise

• Publication

Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care

• Public Comments

EDPB Stakeholder event on the application of the GDPR to the processing of personal data for scientific research purposes

• Meeting Summary

Ethical Challenges in Community Engagement

• Publication

Justice, diversity, and research ethics review

• Publication

A Descriptive-Multivariate Analysis of Community Knowledge, Confidence, and Trust in COVID-19 Clinical Trials among Healthcare Workers in Uganda

• Publication

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

• Annual Report

2020 MRCT Center Impact Report

• Publication

Real-World Evidence: Understanding Sources of Variability Through Empirical Analysis

• Publication

Lack of harmonization of coronavirus disease ordinal scales

• Publication

On measuring attitudes about payment for research

• Meeting Summary

Artificial Intelligence in Clinical Research Meeting Summary

• Publication

Critics say new NIH policy on scientific data sharing falls short

• Publication

How to fix the GDPR’s frustration of global biomedical research

• Public Comments

Comments to European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers

• Public Comments

Comments to the European Commission on the Challenges that GDPR Raises for Research

• Public Comments

Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)

• Publication

Diagnostic Testing for COVID-19: Considering False Positive and False Negative Results by Deborah A. Zarin, MD, MRCT Center Program Director and Joseph Lau, MD

• Meeting Summary

Pragmatic Clinical Trials and Real-World Evidence

• Publication

Time for NIH to lead on data sharing

• Publication

Disruptive and Avoidable: GDPR Challenges to Secondary Use of Data

• Meeting Summary

Early Termination of Clinical Trials

• Publication

Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov

• Presentation

Data Safety Monitoring Board Training Videos

• Public Comments

Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance

• Publication

Committing to the Inclusion of Diverse Populations in Clinical Research

• Meeting Summary

Ethical Challenges in Adaptive and Platform Trials

• Annual Report

2019 MRCT Center Impact Report

• MRCT Sponsor Resource
• Presentation

MRCT Center 2019 Annual Meeting Slides

• Publication

10-Year Update on Study Results Submitted to ClinicalTrials.gov

• Publication

The Culture of Trial Results Reporting at Academic Medical Centers

• Presentation

Ethics of Payment in Clinical Research

• Publication

Trial Effort: Deborah Zarin on Clinical Decision Making and Building a Database for Clinical Trial Results

• Publication

Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey

• Publication

Harms From Uninformative Clinical Trials

• Publication

Relocation of Study Participants for Rare and Ultra-Rare Disease Trials: Ethics and Operations

• Publication

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence

• Publication

Credit Data Generators For Data Reuse

• Publication

Social Media as an Ethical Tool for Retention in Clinical Trials

• Publication

Scientific Merit Predicates Ethical Review of Clinical Research

• Meeting Summary

Impact of Mobile Technologies on Clinical Research

• Publication

Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered

• Meeting Summary

Impact of Social Media on Clinical Trial Integrity

• Public Comments

Comments to EDPB on the Guidelines on the Territorial Scope of the GDPR

• Other

Harmonized Governance Tools for Data Sharing Info Sheet

• Other

Research, Development, and Regulatory Roundtable Info Sheet

• Other

Bioethics Collaborative Info Sheet 2018

• Proceedings

Data Anonymization – A Key Enabler for Clinical Data Sharing

• Annual Report

2018 MRCT Center Impact Report

• MRCT Sponsor Resource

MRCT Center 2018 Annual Meeting Slides

• Framework

Data Contributor Agreement

• Framework
• MRCT Sponsor Resource

Data Use Agreement

• MRCT Sponsor Resource
• Tools

Data Use Agreement Word Document

• Framework

Data Sharing Plain Language Informed Consent Form Section

• MRCT Sponsor Resource
• Tools

Data Sharing Plain Language Informed Consent Form Section Word Document

• Meeting Summary

Return of Individual Results to Research Participants and Axes of Communication

• Publication

Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study

• Proceedings

Implementing A System to Enable Credit for Data Sharing

• Publication

Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials

• Publication

On Scarcity and the Value of Clinical Trials

• Meeting Summary

Enabling Informed Selection of Clinical Trials

• Publication

A Framework for Ethical Payment to Research Participant

• Annual Report

2017 MRCT Center Progress Report

• Tools

Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians and Institutional Review Boards

• MRCT Sponsor Resource
• Presentation

MRCT Center 2017 Annual Meeting Slides

• Other

Bioethics Collaborative Info Sheet 2017

• Presentation

Advancing Data Sharing: Data Collection As a Key Component

• Publication

What Do Revised U.S. Rules Mean for Human Research

• MRCT Sponsor Resource
• Presentation

Guiding Principles for Clinical Trials 2017

• Other

About Vivli Info Sheet

• Publication

Data Authorship as an Incentive to Data Sharing

• Publication

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

• Publication

HHS Finalizes Comprehensive Revisions to the Common Rule

• Presentation

Clinical Trial Data Sharing

• Annual Report

2016 MRCT Center Impact Report

• Other

Introducing Vivli

• MRCT Sponsor Resource
• Presentation

MRCT Center 2016 Annual Meeting Slides

• MRCT Sponsor Resource
• Presentation

MRCT Center 2016 Annual Meeting Slides

• Presentation

CDISC International Interchange

• Publication

Responsibilities of Data Monitoring Committees: Consensus Recommendations

• Publication

A Global, Neutral Platform for Sharing Trial Data

• Publication

When clinical trials compete: prioritizing study recruitment

• Presentation

A Vision from the MRCT Center to Promote Clinical Trial Data Sharing

• Presentation

Global Data Sharing and Transparency Initiatives

• Presentation

Future of Clinical Trial Data Sharing Transparency Slides Day 2

• Proceedings

Future of Clinical Trial Data Sharing Transparency

• Presentation

Webinar for India Regulatory Update

• Presentation

Towards Streamlined Consent Processes and Participant Understanding

• Presentation

Responsible Clinical Trial Data Sharing

• Presentation

MRCT Center 2015 Annual Meeting Data Sharing Slides

• Annual Report

2015 MRCT Center Progress Report

• MRCT Sponsor Resource
• Presentation

MRCT Center 2015 Annual Meeting Slides

• Presentation

FDLI Webinar Data Sharing Slides

• MRCT Sponsor Resource
• Presentation

DMC Training in South Africa

• Presentation

Data Sharing Roundtable

• Presentation

Clinical Data Transparency Solutions for Sharing Participant Level Data

• Presentation

DIA Clinical Trial Data Sharing

• Public Comments

Scientific Data – Editorial Comments

• Presentation

Executive and Steering Committee Meeting