A REVIEW ON: CLINICAL TRIALS: PHASES, ETHICS, AND CHALLENGES

*Ms. Vaishnavi K. Chivte, Ashlesha Rajesh Chandale, Dr. Vijaykumar Manohar Kale, Dr. Mahesh Madhavrao Thakare, Mr. Vaibhav Laxmikant Narwade, Ms. Dhanashree Kiran Chivte

ABSTRACT

Evidence-based medicine relies on clinical trials to gather the necessary information about new medications, biologics, devices and treatments regarding their safety, and efficacy. This article describes the various phases of clinical trial development along with the ethical principles that guide the structure of these trials and key factors considered during the conduct of these trials. Clinical trials begin with preclinical testing and continue through Phase 0 through Phase IV of clinical development with each phase having specific objectives, including safety, efficacy, verification and long-term follow-up monitoring. While scientific based, clinical research has been developed using ethical principles derived from previous mistakes and from the application of the principles of justice, informed consent and the use of Independent Ethical Committee (IEC) reviews to protect the welfare of the participant. Unfortunately, clinical trials experience many problems, including extended time frames, expensive costs, complicated regulations, and substantial issues related to patient recruitment and retention. However, new methods of conducting clinical trials (such as decentralized trials, utilizing Artificial Intelligence, or adaptive designs) are being introduced to enhance the efficiency and inclusivity of clinical trials. Ultimately, clinical trials carried out under ethical standards have an impact on the ability to guarantee that new treatments will be both effective and safe, as well as be available to the populations that benefit from them.

Keywords: Clinical Trials, Phases of Clinical Trials, Research Ethics, Informed Consent.