Ethics, conduct, and oversight
Context
There are recognized limitations of efficiency and effectiveness in the conduct of global clinical trials. Sponsors must navigate both ethical and pragmatic questions when designing protocols for multi-regional clinical trials. Additional issues may arise in the context of resource-poor environments with less existing infrastructure, both human and material.
Challenge
Governments, sponsors, researchers, institutions, the public, and other stakeholders all wish to protect human research participants and to treat host communities in a just and equitable manner.
MRCT Center Projects
In this focus area, we build capacity to ensure that clinical trials are performed safely and ethically by rigorous methodology. We convene representatives from government, industry, IRBs/RECs, not-for-profit entities, patients, and academia to create practical resources for the ethical design, conduct, and oversight of multi-regional clinical trials.
projects in this area include:
Advancing the Quality of Clinical Trial Enterprise
Improving the design and the quality of clinical trial reporting will result in a reduction in the number of non-informative trials that are initiated. Along with improved trial reporting, the impact will be a higher quality clinical trial evidence base and ultimately the improved use of clinical trial data to inform research decisions. Read more.
Bioethics Collaborative
The MRCT Center Bioethics Collaborative is an impartial forum for individuals from academia, industry, patient groups, ethics committees, and government to share, define, study, and propose ethical frameworks to address issues arising in the context of multi-national clinical trials for drug and device development. Read more.
Diversity, Inclusion and Equity in Clinical Research
Ideally, the participant population enrolled in clinical trials reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. In most clinical trials, however, the sex, race, ethnicity, and age of the participant population are not representative of the population at large. The MRCT Center Diversity Workgroup developed a conceptual framework, grounded in a clear set of ethical principles, that promotes understanding of the goals of diversity, addressing current barriers to progress, and exploring solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials. Read More
Health Literacy
Prospective research participants should be provided with comprehensible, individually meaningful, and culturally-relevant information about clinical research and the implications of research participation. An MRCT Center workgroup, taking a systems-based approach, developed clinical research-focused health literacy resources for all stakeholders and launched the Health Literacy in Clinical Research website in October 2019. Since the launch, the MRCT Center’s programmatic focus on health literacy throughout the clinical research process has continued to grow. Read more.
Post-trial Responsibilities
Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) after a trial has ended or a participant’s time on trial has completed. The MRCT Center has developed and disseminated principles, a guidance document, and a toolkit. Read more
Proactive Safety Surveillance: A Global Approach
Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. Convened by the MRCT Center in collaboration with others, the Proactive Safety Surveillance Initiative aims to improve upon the current safety surveillance systems by creating an approach to a proactive safety surveillance system that is global in design and scale and that has the potential to identify and validate safety concerns efficiently and cooperatively. Read more
Protocol Ethics
Protocol ethics refers to addressing ethical issues in the design of clinical trials and documenting their rationale in an identified section of the study protocol easily understood by institutional review boards/ research ethics committees. The MRCT Center has developed a protocol ethics toolkit and e-learning course for sponsors and investigators to enhance ethical considerations in study design and protocol documents. Read more
Research, Development, and Regulatory Roundtable (R3)
A cooperative endeavor of the MRCT Center and Ropes & Gray LLP, the R3 is an impartial forum wherein policymakers, legal counsel, academicians, industry representatives, and global regulators present, discuss, and deliberate pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human participants research. Read more
Resources for Patients and Participants
Accurate health and research information from trusted, reliable sources is needed. The MRCT Center is committed to empowering individuals to understand clinical research and to make informed choices about whether to join, and remain in, research studies. Read more
