BRIDGING RESEARCH AND THERAPEUTICS: A COMPREHENSIVE REVIEW OF CLINICAL TRIAL METHODOLOGIES AND ETHICAL CONSIDERATIONS

Nikita Rajkishor Diwakar*

ABSTRACT

Clinical trials are essential for translating experimental research into effective therapeutic innovations. For example, the development of the COVID-19 vaccines, such as Pfizer-BioNTech and Moderna, demonstrated how clinical trials can rapidly translate research into life-saving therapies. These carefully designed studies assess the safety, efficacy, and long-term impact of new drugs, medical devices, or treatment strategies. The clinical trial process is divided into distinct phases, starting with early-stage safety evaluations in Phase I, followed by efficacy testing in Phase II, large-scale confirmatory studies in Phase III, and post-marketing surveillance in Phase IV. Ethical considerations, including informed consent, confidentiality, and participant welfare, are crucial to maintaining trial integrity. These principles are practically enforced through comprehensive informed consent procedures, ensuring participants fully understand trial risks and benefits before enrolment. Data encryption and secure storage systems safeguard participant confidentiality. Additionally, independent ethics committees rigorously review trial protocols to confirm adherence to ethical standards. Regulatory frameworks, such as the ICH-GCP Guidelines, ensure global standardization of clinical trials, while agencies like the FDA, EMA, and DCGI oversee implementation. India has emerged as a key hub for clinical trials due to its diverse population and cost-effective research infrastructure. Despite advancements, challenges like participant recruitment, data integrity, and regulatory complexities persist. This review highlights the clinical trial process, ethical principles, regulatory frameworks, and the evolving landscape of clinical research in India.

Keywords: Clinical Trials, Drug Development, Ethics in Research, Informed Consent, Clinical research.