Principles regulating clinical trials worldwide

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Principles regulating clinical trials worldwide

● Obtaining clear, transparent, and informed consent from participants.

● Allowing participants to withdraw at any point of time from a clinical trial.

● The outcome of the clinical research should provide benefits to society without doing any harm to the participants who volunteered to participate in the clinical trial.

Any unintended response to a drug or medical product should be considered an adverse reaction. Clinical trials are required to follow the following guidelines and more to ensure the safety of patients and efficacy of tests and treatments. However, stringent requirements may force clinical trials to shift to low-income and middle-income countries depriving the local population of the opportunity to benefit from international clinical research.

● A declaration of confirmation by the auditor that an audit has been conducted.

● The auditor should provide a written evaluation of the results of the audit.

● A written description of a clinical trial or study.

● Report of placebo or any investigational product if used in the clinical trial.

● The ethical and moral obligation to protect patients and reap clinical research benefits.

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The conclusions derived from the results of a clinical trial conducted worldwide generally apply to all study centers and countries. It increases the pace of drug development and facilitates the approval process of the tests and treatments in foreign markets. However, clinical trials face several challenges that they should overcome to ensure optimal conduct and coordinate clinical trial sites that operate under different regulations, technical, cultural, and political conditions. Clinical trial sponsors are responsible for obtaining consensus among clinical experts and regulatory agencies regarding fundamental questions that include a consistent diagnosis.

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