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.
Highlights
Serious considerations by regulatory authorities are taken to safeguard the patient’s right, safety and wellbeing involved in a clinical trial
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
Today is the era of evidence based medicine and foremost emphasis is being given for protection of ethics in the clinical trials
Summary
Today is the era of evidence based medicine and foremost emphasis is being given for protection of ethics in the clinical trials. As there were no established regulations to conduct preclinical or clinical trials, new suspension was not studied for safety and toxicity. Due to its adverse effects on embryogenesis, System for Thalidomide Education and Prescribing Safety [S.T.E.P.S.] program was initiated by Celgene pharmaceuticals which provide regulations for drug marketing and essential patient education [29]. FDA took this step after reevaluation of safety data obtained from the clinical trials of Valdecoxib and risk-benefit assessment as there was no information regarding the association of cardiac safety even with the prolonged use of Bextra [89]. Ticrynafin was marketed as loop diuretic drug and it lowered the uric acid levels It got approval by FDA in 1979 for treatment of hypertension.
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