Clinical Trials and New Drug Approvals: Insights from ISCR and FDA

Challenges in Clinical Trials

India's involvement in global clinical trials is limited, standing at only 3-4 percent. This statistic raises concerns regarding regulatory reforms and new drugs related to clinical trial rules. Key challenges identified include insufficient resources at clinical sites, especially in government hospitals, which demand substantial infrastructure investments to align with international benchmarks.

Addressing Skill Gaps and Professional Training

The shortage of qualified clinical trial management professionals significantly contributes to delays in trials. Targeted training programs and academic collaborations are essential for building a capable workforce to address this need.

Enhancing Patient Recruitment and Retention

Difficulties in patient recruitment and retention necessitate improved engagement strategies. Fostering public awareness through community outreach can enhance participation rates, ultimately benefiting clinical trial outcomes.

Digital Transformation in Clinical Trials

Advancements in digital health are vital for the future of clinical trials. Integrating technologies like telemedicine and electronic health records makes participation more accessible and efficient, promoting diversity among trial participants.

Collaboration and Transparency in Clinical Research

Increasing collaboration between patients, ethics committees, and regulatory agencies can expedite drug development. Enhanced transparency through accessible regulatory documents empowers public trust and strengthens clinical research integrity.