View this email in your browser

December 2022

Clinical Trial Optimization in Kenya and Nigeria

In collaboration with AVAREF and WHO, Dr. Barbara Bierer, MRCT Center Faculty Director, recently traveled to Kenya and Nigeria to learn about the current challenges in clinical trial application review and approval processes in the two countries, including the identification of root causes of delay, and to help develop mitigation strategies. WHO also piloted the use of an ethics benchmarking tool created by a WHO committee on which Dr. Bierer served in 2021.

left to right: Carl Coleman: Professor of Law, Seton Hall Law School; Barbara Bierer, MD: Faculty Director, MRCT Center and Professor, Harvard Medical School; Moji Christianah Adeyeye, PhD, FAS: Director-General, NAFDAC; Diadié Maïga, PharmD, PhD: Technical Officer, Vaccine Regulation, UCN/Vaccine Preventable Diseases: WHO – Regional Office for Africa; Alambo Mssusa: Consultant for Regulation and Safety, UCN/Vaccine Preventable Diseases: WHO – Regional Office for Africa

Office of the Director-General, Lagos, Nigeria

Virtual Training for Biotechnology Lecturers in Indonesia

In October 2022, as part of 2022 Association of Indonesia’s Biotechnology Study (IPSBI) Programs, the MRCT Center delivered virtual training to provide advanced learning for public and private university lecturers who teach in undergraduate and graduate biotechnology degree programs in Indonesia. The training focused on real world data, genomics, and research ethics to capacitate and advance the field of biotechnology at the university and graduate level.

Learn more

PUBLICATIONS

October 31, 2022: The Office of Research Integrity (ORI) put out a request for information and comments (RFI) related to the 2005 PHS Policies on Research Misconduct (42 C.F.R. Parts 50 and 93). Comments were submitted on behalf of Ropes & Gray and the MRCT Center as well as a number of collaborating institutions.

Learn More.

October 21, 2022: Drs. Bierer and DeCormier Plosky co-authored an article led by Benjamin C. Silverman (MGB) entitled “Supported decision-making can advance clinical research participation for people with disabilities,” published in Nature Medicine.

Learn More.

October 3, 2022: Willyanne DeCormier Plosky, Program Manager at the MRCT Center, and Dr. Bierer, with others, co-authored “Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification,” published in Health Affairs, available for free (open access).

Learn More.

October 2, 2022: The MRCT Center provided public comments to the U.S. Department of Health and Human Services, Office for Civil Rights about “Docket No. RIN 0945-AA17, Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act.”

Learn More.

September 29, 2022: To explore the operational and statistical complexities of analyzing pooled individual patient data (IPD), Dr. Bierer and colleagues performed a meta-analysis that reinforced that hydroxychloroquine/chloroquine is not efficacious for treatment of COVID-19 in hospitalized patients, published as “Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis” in PLoS One.

Learn More.

September 28, 2022: In an Open Peer Commentary, “Externalist, Process-Based Approach to Supported Decision-Making,” published in the American Journal of Bioethics, Dr. Bierer and collaborators Leslie Francis and Michael Stein defended a process-based approach in which people with cognitive disabilities choose supporters to facilitate their making or communicating decisions. 

Learn More.

• Dr. Bierer was welcomed to the Executive Committee of the Clinical Trials Transformation Initiative (CTTI). Learn more.