Tragedies in Clinical Trials - A History Wrapped Up

Abstract

Today foremost emphasis is being given to the protection of patient’s safety and ethics during the conduct of clinical trials. Serious considerations by regulatory authorities are taken to safeguard the patient’s right, safety and wellbeing involved in a clinical trial. In addition considerations like International Conference on Harmonization (ICH) guidelines, Investigational New Drug (IND) application, New Drug Application (NDA), Post Marketing Surveillance (PMS) and Periodic Benefit-Risk Evaluation Report (PBRER) formerly known as Periodic Safety Update Report (PSUR) submissions to different regulatory authorities has also been framed to strengthen ethics and patient’s safety. However modern clinical trials have evolved through serious consequences and tragedies like Thalidomide Tragedy, Sulfanilamide Disaster, Clioquinolol Tragedy, etc. associated with high morbidity and mortality. Potential reasons behind these tragedies include unethical clinical practices, inadequate preclinical safety and efficacy data, non-scientific conduct, lack of attentiveness for patient care, misinterpretation of safety data, lack of pharmaco-vigilance, slow withdrawal of drug from market etc. Hence toiling efforts have been made and should be made in investigating lacunas in national as well as international systems that encourage launch of such spurious drugs that needed withdrawals after 10-20 years of public use. This manuscript intends to collect and present data on tragic clinical trials, highlight the tragedies that occurred during the dark era of clinical trials and enumerate various corrective actions taken in response to the lessons learnt during those clinical trials.