Companies develop numerous processes to ensure compliance and protect patient safety.
BIO has long supported responsible and ethical testing, protection of individual privacy and genetic information, and regulatory systems that best serve humanity and advance research into new treatments for patients, regardless of where research is conducted. Toward that end, BIO supports appropriate oversight of clinical trials and medical research, whether conducted in the U.S. or elsewhere in the world. Performing important research and protecting research subjects are mutually attainable goals, and decisions regarding whether and how to use medical products and technologies must always be made with profound respect for the rights of patients.
Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards regardless of where the research is conducted. FDA regulations require trial sponsors to undertake several quality assurance and audit activities, and failure to abide by these rules could delay or disqualify a product’s chances of getting marketing approval. Companies develop numerous processes to ensure compliance and protect patient safety, including:
Pharmacovigilance conducted by experts (oftentimes hundreds of individuals) who collect, analyze, follow-up, and distribute safety-related information from new drug trials.
Establishment of independent data and safety monitoring boards to impartially evaluate safety as studies progress.
Regular sponsor monitoring of clinical trial sites to ensure quality, compliance, and safety of research participants.
Quality assurance units that audit operations associated with clinical research to ensure adherence of company personnel to regulations, guidelines, and internal and external procedures, policies, and programs.
Unethical clinical trials, however rare, tarnish the reputation of all researchers and their work. BIO members are deeply concerned about any instance of unethical clinical research, and take seriously the ethical issues involved in conducting overseas clinical trials. Regulation of clinical trials should be solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom. Encouraging and enabling innovation through a timely and consistent regulatory process will ultimately result in medical treatments and cures that improve lives worldwide.
For more information, please go to http://www.bio.org/category/bioethics.
A copy of the report from the Presidential Commission for the Study of Bioethical Issues entitled, "Moral Science: Protecting Participants in Human Subjects Research," may be found here: