There are recognized limitations of efficiency (e.g. the time it takes to get a protocol reviewed) and effectiveness (e.g. the quality of the review and its ability to detect ethical problems) of the review of planned clinical trials by the institutional review boards or research ethics committees. Additional issues may arise in the context of resource-poor environments with less existing infrastructure, both human and material.
Sponsors, researchers, institutions, patients, 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 on the basis of a strong and efficient process of independent ethical review. We convene representatives from industry, not-for-profits, patients, and academia to create practical resources for the ethical design and conduct of multi-regional clinical trials.
Current projects in this area include:
Protocol ethics refers to addressing ethical issues in the design of studies and documenting their rationale in a preferably identified section of the study protocol. The MRCT Center convened a workgroup to develop a protocol ethics toolkit and e-learning course. Read more
Informed Consent Language
Data sharing language in informed consent forms is inconsistent. Terminology varies, and references to “your data,” “pseudo-anonymized data,” and “your de-identified data” are used interchangeably. As a result, participants are left unaware of the purposes, risks, and benefits of data sharing. The MRCT Center with its partners are developing harmonized terminology and educational materials. Read more
Representation of Diverse Populations in Multi-Regional Clinical Trials
Ideally, the participant population enrolled in clinical trials is reflective of the general population or of the disease distribution in order to provide generalizable knowledge pertinent to that population. In most clinical trials, however, sex and ethnicity are underrepresented and not representative of the population at large. This is particularly problematic for trials of drugs and biologics, as efficacy and safety of medicines can vary depending on several intrinsic and extrinsic factors. The MRCT Center is bringing together a group of stakeholders to generate a systematic guidance document.
Post-trial responsibilities refer to providing continued access to study interventions (and potentially other care) once a trial is over or a subject’s participation has ended, potentially including access to study medications and/or health care infrastructure. The MRCT Center convened a multi-stakeholder team to develop a guidance document and toolkit. Read more
MRCT Bioethics Collaborative
The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development.