A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
According to Indian Good Clinical Practice guidelines, a clinical trial is a systematic study of pharmaceutical products on human subjects (whether patients or non-patient volunteers) in order to discover or verify the clinical, pharmacological (including pharmacodynamics/pharmacokinetics), and/or adverse effects, with the object of determining their safety and/or efficacy.
Such trials can be categorised into
- Clinical trials that require approval from the Central Licensing Authority (CLA) i.e. Central Drugs Standard Control Organization (CDSCO): These are clinical trials of a new drug or investigational new drug. As per Indian regulations, this includes any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its (i) clinical, or (ii) pharmacological including pharmacodynamics, pharmacokinetics, or (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.
- Clinical trials that do not require approval from the CLA (CDSCO): Such trials are also termed ‘academic clinical trials’. As per Indian regulations, this is a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are used only for academic or research purposes and not for seeking approval of the CLA (i.e. CDSCO) or regulatory authority of any country for marketing or commercial purpose.
A carefully considered and well-planned clinical trial is integral to ensuring a successful outcome. It is recommended, that the researcher collaborates with relevant experts (like relevant subject area experts, biostatisticians, etc.) to design the trial. Such collaboration will ensure the robustness of the trial design, help identify key requirements for the trial, facilitate the process of applying for funding, and at subsequent stages obtain the necessary approvals from regulatory agencies and ethics committees.
Trial planning is the overarching term used to encompass the various steps involved in the trial such as trial design, funding, etc. This document could be used as a checklist or Gantt chart (or both, as required) and lists the required (and important) steps to be followed while setting up or planning a new trial. It is recommended that where possible, the various steps mentioned in the document are carried out in parallel.
References and Further Reading
- Clinical Trials (Health Topics), World Health Organization, available online (last accessed 15.03.2019).
- NIH’s Definition of a Clinical Trial, National Institutes of Health, U.S. Department of Health and Human Services, available online (last accessed on 15.03.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2017, available online (last accessed on 10.03.2022).
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 03.04.2019).
- National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed 05.07.2019).
- ICH Harmonised Tripartite Guideline – E8(R1) General Considerations for Clinical Studies, final version, dated 6th October 2021 (last accessed on 09.03.2022).