Ethics, conduct, and oversight
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.
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.
Current projects in this area include:
The MRCT Center Bioethics Collaborative is a neutral forum to foster the discussion of bioethical issues among stakeholders involved in global clinical trials for drug and device development. Read more.
Prospective research participants should be provided with comprehensible, individually meaningful, and culturally-relevant information about clinical research and the implications of research participation. The MRCT Center is working on clinical research-oriented tools and resources for stakeholders responsible for communicating clinical research materials to the participants. Read more.
Informed Consent Language
Informed consent is a core requirement of ethical human subjects research. Regulatory bodies often require that several key pieces of information be provided to potential research participants. The MRCT Center has facilitated several practical approaches to enhancing the communication and comprehension of clinical research information. By equipping research participants with coherent, intelligible information about clinical research, we strive to uphold the foundational ethical principles of informed consent. Read more
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
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
Representation of Diverse Populations in Multi-Regional Clinical Trials
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 is working on a clear set of ethical principles and a conceptual framework that promote 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
Research, Development, and Regulatory Roundtable (R3)
A cooperative endeavor of the MRCT Center and Ropes & Gray LLP, the R3 is a neutral forum wherein policymakers, legal counsel, academicians, industry representatives, and global regulators may present, discuss, and deliberate pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Read more