‘Guidance for best practices for clinical trials’ released by WHO

Posted 26 Sep 2024

2 min read

Guidance aims to enhance clinical research efficiency, minimize research waste, and provide guidance on sustained clinical trials that are always functional and active for endemic conditions and can pivot in time of emergency or pandemics.

Clinical Trials are carefully controlled research study conducted to evaluate the safety, efficacy, and effectiveness of new medical treatments, drugs, devices, or interventions.

Persistent Challenges to Clinical Trials

Waste in clinical trials: Due to factors such as failure to articulate clear research questions, duplication of previous research, use of inefficient trial processes, etc.
Inadequate funding for clinical trial infrastructure: Resulting in inequity and a lack of justice in fairly accessing affordable, safe, and efficacious interventions, as highlighted during COVID-19 Pandemic.
Others: Global divide among high-income and low-income countries, lack of diversity in clinical trial cohorts, lack of standardized practices resulting in mistrust in research, etc.

Key Highlights of the Guidance

Recognize regional and global health research priorities in national research programmes and their funding.
Competent local research ethics committees: Should have multi-disciplinary membership with independent operations and autonomy in decision-making.
Encourage automated and digital processes: To increase clinical trial speed, efficiency, and transparency.
Diversity in trial cohorts: Trials to include pregnant and lactating women, given they have unique healthcare needs.

Regulation of Clinical Trials in India

Clinical trials of new drugs are regulated under Schedule Y of the Drugs and Cosmetic Rules, 1945.
Good Clinical Practice (GCP) guidelines issued by Central Drugs Standard Control Organisation (CDSCO).
- The sponsor and investigator should be aware of the approval process(es) involved in conducting clinical trials of vaccines.
- Safety data of the medical device in animals should be obtained and likely risks posed by the device should be considered.
- Informed consent should be obtained before any diagnostic procedures.

Ethical Guidelines for Biomedical Research on Human Participants (2006) and National Ethical Guidelines for Biomedical Research Involving Children (2017) by ICMR.