Publication
Published on: July 13, 2018
Published in: Journal of Medical Internet Research
Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India
Resource Type: Publication
Fair payment and just benefits to enhance diversity in clinical research
Implementing expanded COVID-19 testing in Massachusetts community health centers
Publication
Published on: July 2022
Published in: Contemporary Clinical Trials
When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research
Publication
Published on: May 11, 2022
Published in: Ethics & Human Research
MRCT Center Project Manager Walker Morrell, Barbara Bierer and colleagues co-authored “When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research” in Ethics & Human Research. Digital applications (apps) used in research may be updated while the research is ongoing, potentially necessitating ethics review. The authors argue that the review process should depend on the nature of the change, any potential change in risk or benefit, and consideration of confidentiality and safety.
Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing in Clinical Therapeutics
Publication
Published on: February 25, 2022
Published in: Clinical Therapeutics
MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner.
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training
Publication
Published on: March 31, 2022
Published in: Therapeutic Innovation & Regulatory Science
The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.
How To Use Plain Language in Clinical Research Communications
Publication
Released on: February 4, 2022
Published in: Institute for Healthcare Advancement (IHA) blog
Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community
Publication
Released on: January 31, 2022
Published in: Journal of Clinical and Translational Science
Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies
Publication
Presented on: December 15, 2021
Published on: The Hastings Report
Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.
Publication
MRCT Center colleagues author an article in JAMA Network Open with Dr. Tony Tse.
Presented on: November 18, 2021
Published by: JAMA Network Open
MRCT Center Executive Director Sarah White, Senior Advisor Luke Gelinas, Project Manager Walker Morrell, Faculty Director Barbara Bierer, and Program Director Deb Zarin authored an article in JAMA Network Open with Dr. Tony Tse: “Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.”
