Clinical Trials

Clinical trials are carefully designed research studies that test whether a new medicine, vaccine, procedure or device is safe and more effective than what is already available. Every treatment in use today — antibiotics, vaccines, chemotherapy, BP tablets — became available because of clinical trials.

Phases

• Phase 1 — small group; checks safety and dose.
• Phase 2 — larger; checks whether it works, and more about safety.
• Phase 3 — large, often multi-country; compares to standard treatment. Results here drive approval.
• Phase 4 — after approval; tracks long-term safety in the real world.

Should you take part?

Joining a trial can give access to a promising new treatment, and contributes to knowledge that helps future patients. It also carries risks and uncertainties — that's exactly why a trial is being done. A good trial explains everything in plain language, gives time to decide, and lets you withdraw at any time.

What to ask before joining

• What is the purpose of this study?
• What treatment will I get? Will I know what I'm getting?
• What are the possible benefits and risks?
• How does this compare to the standard treatment I would get otherwise?
• What tests and visits will be needed? Over how long?
• Are there costs to me? Will travel or lost wages be reimbursed?
• Who pays for my care if something goes wrong?
• Can I leave the study at any time?
• Will my personal data be kept confidential?
• Who has reviewed and approved this study?

India-specific safeguards

• Clinical trials in India are regulated under the New Drugs and Clinical Trials Rules; every trial must be registered on the CTRI (Clinical Trials Registry of India) before starting.
• Trials are reviewed by an ethics committee; consent must be informed, in a language you understand.
• You should never be charged to participate.
• Compensation for study-related injury is mandated.
• If in doubt, check ctri.nic.in for the trial registration, or ask for the ethics committee contact details.