WASHINGTON, D.C. (Thursday, November 17, 2011) - Russell M. Medford, MD, PhD, President and CEO of Salutria Pharmaceuticals, LLC provided testimony on Wednesday, November 16 to the Presidential Commission for the Study of Bioethical Issues on BIO’sPrinciples Regarding Ethical Performance of International Clinical Trials. Dr. Medford is co-chair of BIO’s Board Standing Committee on Bioethics.
“BIO members support appropriate oversight of clinical trials and medical research, whether conducted in the U.S. or elsewhere in the world,” said Dr. Medford. “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.”
Research conducted 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 complianceand protect patient safety, including:
Standard operating procedures, technical operations policies, and training programs for staff.
Pharmacovigilance conducted by experts (oftentimes hundreds of individuals in one company) who collect, analyze, follow-up, and distribute safety-related information from new drug trials.
Establishment of 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,” said Dr. Medford. “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.”
“Appropriate regulation of biotech 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 for some of the most devastating and life-threatening diseases,” said Dr. Medford.
BIO's Board of Directors has adopted a Statement of Ethical Principles, and continues to refine a comprehensive vision of ways to ensure biotechnology is used for the betterment of humankind. BIO's Bioethics Committee is responsible for actively encouraging discussion of ethical and social implications of scientific developments in biotechnology.