Dr. Russell Medford, Salutria Pharmaceuticals, recently wrote an article for BIOtechNOW on the Ethics of Global Clinical Trials. Dr. Medford concedes that some in the industry have asserted that sponsors conduct clinical trials abroad to avoid red tape and overly stringent and time consuming regulatory processes. However, he goes on to point out that any 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.
Unfortunately, history shows there have been trials conducted in unethical ways in all parts of the world, tarnishing the reputation of all researchers and exacerbating misconceptions about global trials. However, it’s important to note that unethical trials are exceptionally rare.
Ethics aren’t defined by geographical borders, but are linked to cultural and moral behaviors and values. When talking about clinical research, ethics must be implicit in every single act, every step of the process. If unethical, it’s not clinical research.
Fortunately, there are many different international standards and regulations that control and oversee the way global trials are implemented and conducted. Countries involved in the conduction of clinical research must comply with Good Clinical Practice (GCP) standards as well as with precise requirements (IRB/ECs active participation, audits, inspections, standard procedures, and more) to warrant the protection of participants’ rights and welfare, as well as ensure the quality of data generated.
Sponsors must also take responsibility for ensuring their trials are conducted ethically within specific regional standards and protocols. As Dr. Medford points out in his article, pharmacovigilance, drug and safety monitoring boards, regular monitoring, and QA audit operations all serve to ensure compliance and protect patient safety. Failure to abide by these regulations could significantly delay or disqualify FDA approval.
Working together globally – ethically sharing ideas, innovations, processes, techniques, and methodologies – we stand to find treatments for and even eradicate some of the most devastating diseases known to man.