Resource Type: Publication

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

Publication

Published on: April 26, 2023

Published in: International Journal of Clinical Trials

Description: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” describing the experience of conducting a multinational acupuncture study during the pandemic.

View Publication

Bringing data monitoring committee charters into the sunlight

Publication

Published on: May 25, 2023

Published in: National Center for Biotechnology Information, NIH

Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.  

DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.
Link to PubMed article

How To Limit Uninformative Trials: Results From A Delphi Working Group

Publication

Published on: April 18, 2023

Published in: CellPress Med

Free access until June 7, 2023

Description: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.

View Publication

Permanent Link

DEI in Clinical Research: Tools & Resources for Incorporating DEI in IRB/HRPP Processes (AAHRPP poster)

Poster

Presented on: May 2023

Presented at: 2023 Annual AAHRPP Conference

The MRCT Center has developed a set of practical diversity, equity, and inclusion (DEI) tools for IRBs and HRPPs, designed to improve the involvement of underrepresented populations in clinical research. In 2021, a task force of 28 IRB and HRPP professionals, convened by the MRCT Center, created 15 DEI tools. The tools underwent rigorous review and revision during nine months of monthly meetings and additional correspondence. 

Three highlighted tools in the poster include:

  • Checklist of Logistical and Procedural Considerations: Assists in lowering barriers to inclusion, covering Pre-Study, On-Study, and Post-Study Considerations.
  • HRPP Planning Strategy to Address DEI: Offers a plan involving support, key stakeholders, guidance utilization, and process evaluation.
  • Incorporation of Diversity and Inclusion into Clinical Research Protocol Templates: Provides DEI recommendations within protocols, along with annotated examples.

Hayat Ahmed, MS, Program Manager at the MRCT, showcased this poster at the Annual AAHRPP conference in May 2023. Conference participants awarded Ms. Ahmed the distinguished poster prize.

Download Poster
2023-04-24_HRPP-IRB tools_poster

Data sharing in the context of community-engaged research partnerships

Publication

Published on: May, 2023

Published in: Social Science & Medicine

Description: As data sharing is expanded in the context of greater community engagement in research, we must ask to whom do benefits of data sharing accrue and to whom do benefits not accrue? In an era of growing efforts to engage diverse communities in research, the impact of data sharing for all research participants and the communities that they represent requires the reassessment of the principles of data sharing, incorporating principles of community-engaged research. This article outlines these considerations and proposes new models of benefit sharing.

View Publication