WHO’s efforts to strengthen broader clinical trials ecosystem

• The World Health Organisation (WHO) launched the Global Clinical Trials Forum (GCTF) on October 7.

• The GCTF represents a significant step towards ensuring that all countries have the capacity to generate reliable evidence to guide health policy and practice. 

• It is a global, multi-stakeholder network to strengthen clinical trial environments and infrastructure at national, regional and global levels. 

• The Forum responds to a World Health Assembly resolution, which called on WHO to improve the quality and coordination of clinical trials to generate high-quality evidence for health decision-making. 

• The GCTF supports the implementation of WHO’s Guidance for Best Practices for Clinical Trials, which sets out principles and actions to improve the design, conduct, oversight and use of trials. 

• It is further guided by the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS), which translates the guidance into nine priority action areas addressing barriers across current clinical trial ecosystems. 

• By connecting diverse stakeholders including Member States, regulators, ethics authorities, funders, researchers, civil society and patient/community engagement organisations, the GCTF provides a collaborative platform for members to disseminate WHO guidance and best practices, engage and advocate with stakeholders to promote adoption of standards, and share knowledge to strengthen capacity and advance inclusive, ethical and impactful clinical trials.

What are clinical trials?

• Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. 

• People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

• Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. 

• People of all ages can take part in clinical trials, including children.

There are four phases of biomedical clinical trials:

i) Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.

ii) Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.

iii) Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.

iv) Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

• WHO’s International Clinical Trials Registry Platform (ICTRP) links clinical trials registers globally in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others.

• The ICTRP is a global initiative that aims to make information about all clinical trials involving humans publicly available.

• Beyond the ICTRP, the WHO also leads efforts to strengthen the broader clinical trials ecosystem. 

• In May 2022, the World Health Assembly adopted a resolution on strengthening clinical trials. 

• This resolution emphasizes the critical role of well-designed, ethically guided, and scientifically robust clinical trials in generating the high-quality evidence needed to inform public health policies and interventions.

• As part of its response, WHO has developed the Guidance for Best Practices for Clinical Trials and a Global Action Plan for Clinical Trial Ecosystem Strengthening, which together provide practical recommendations and pathways for all stakeholders including Member States, regulators, researchers, funders and partners to implement the resolution. 

• These initiatives complement the ICTRP by ensuring that, in addition to being visible and accessible, clinical trials are also ethical, equitable, collaborative, and of high quality, so that the evidence they generate can be trusted and used globally.

Regulation of clinical trials in India

• The New Drugs and Clinical Trials Rules, 2019 provide that clinical trials for new drugs are required to be conducted under and in accordance with the permission granted by the Drugs Controller General (India).

• Clinical trials are regulated under Rules 122 DA, 122DAB, 122DAC, 122DD, 122E and Schedule-Y of the Drugs and Cosmetics Rules, 1945. 

• Central Drugs Standard Control Organisation (CDSCO) grants permission for conduct of clinical trials under the said Rules.

• The objective of the drug regulatory system is to ensure availability of safe, effective and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices.

• Clinical trials of new drugs or investigational new drugs are systematic studies on human subjects to generate data for discovering or verifying their clinical or pharmacological including pharmacodynamics, pharmacokinetics or adverse effects with the objective of determining the safety, efficacy or tolerance of such new drugs or investigational new drugs.