Clinical Trials in India

• Cohort study:
  A study of two groups one with pre-existing condition and one without.
• Randomized controlled trial:
  Trial randomly assigning patients to 2 or more groups in a controlled way.
• Case-controlled study:
  Patients with outcomes are studied to ascertain their experience.
• Cross-sectional study:
  Observation of a defined population at a specific time.

1. Trial funding:

Costs involved in a clinical trial are huge and securing a funding is of utmost importance before the trial. Careful planning and budget allocations are needed to secure the finding. Before choosing a funding agency, look for:

Some of the Indian funding bodies include:

• Indian Council of Medical Research (ICMR)
• Department of Biotechnology (DBT)
• Ministry of Science and Technology
• Indo-US Vaccine Action Programme (VAP)
• Biotechnology Industry Research Assistance Council (BIRAC)
• Council of Scientific and Industrial Research (CSIR)
• Department of Health Research

2. Protocol development⁴

A document that defines the objectives, hypothesis, rationale, study design and methodology is known as protocol. A well-designed study relies on a robust and standard protocol.

The New Drugs and Clinical Trials Rules, 2019 shares the essentials of a protocol document.

Here are few sites helpful for protocol writing:

• SPIRIT statement
• NIH Protocol writing guideline (https://e-protocol.od.nih.gov/#/home)
• Protocol template by NHS (https://e-protocol.od.nih.gov/#/home)

3. Essential documents⁵

Essential documents are the documents required for conducting a clinical trial. They individually and collectively ensure the quality and completeness of a trial.

For a detailed list of the documents, please refer
https://ethics.ncdirindia.org/ClinicalToolkit.aspx

Appendix V of Good Clinical Practices and the Indian ICH-GCP guidelines6 provide the list of
essential documents.

4. Approvals

Next step of the process is getting approval for conducting the trial.^7,8

5. Trial conduct

Once the approvals are in place, the trial is conducted on site. The most important aspects of clinical trial conduct are data collection and data management.

Key questions to ask while assessing clinical data^13,14

• Is the research question expressed clearly?
• Is the research question justified and related to the existing knowledge base
  (empirical research, theory, policy)?
• Is the method used to get ethical and/or research/institutional governance explained and cited?
• Method: Does the treatment have a clinically relevant benefit that outweighs the harms? (Statistical significance)
• Is another treatment better? (Compare benefit vs harm profiles)
• Is this treatment feasible in my setting? (Interventions analysis)
• Is there publication bias? (Already existing trial registries and conflict of interest)

Publishing the results¹⁵

Publishing the results are imperative to the trial, no matter positive or negative. It adds to: