Medical Oncologist
Your rights in a clinical trial
Risks, Consent and — Your Right to Withdraw
Joining a clinical trial is a choice — and it stays a choice. Before you sign anything, you are told every known risk and every alternative. You can leave at any point without affecting the care you already have.
Medically reviewed by Dr. C. Raghavendra Reddy, Medical Oncologist, MBBS (Gold Medal) · DNB · DM (Medical Oncology, Gold Medal) · Last reviewed August 2026
- You can leave at any time — Withdrawal is your right at every stage, for any reason, with no effect on your standard treatment.
- Placebo-only arms are rare — ICMR guidelines prohibit placebo-only arms when an effective treatment already exists for your cancer.
- The trial drug is not your cost — The trial sponsor pays for the experimental medicine. You do not pay for being in the trial.
- Consent is a process, not a signature — You are given information to take home, time to decide, and the right to ask any question before you agree.
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Informed consent means you are told every known risk and every benefit before you sign, and you can withdraw at any time without affecting your standard care. In most cancer trials in India, the trial sponsor pays for the experimental drug — you do not. Placebo-only arms are restricted by ICMR guidelines when effective treatment exists.
What does 'informed consent' actually mean?
Informed consent is a process, not a signature on a form. Your trial team is required to explain everything known about the treatment being studied — the possible benefits, the possible harms, what is not yet known, and what your alternatives are — before you make any decision.
You are given a written patient information sheet to take home and read at your own pace. There is no requirement to sign on the same day. If anyone makes you feel that you must decide immediately, that is not how the process should work.
Consent is also ongoing. If new safety information emerges after you have joined, your team must tell you and give you the option to continue or leave.
What should the consent document tell you before you sign?
- The purpose of the trial and what is being tested
- Every known risk, including rare ones — and what remains unknown
- Whether a placebo arm exists and what proportion of participants receive it
- Which costs the sponsor covers and which remain your responsibility
- Your right to withdraw at any time, without giving a reason
- Who to contact if you have concerns, a side effect, or want to leave
- How your medical data will be used, and what happens to it if you withdraw
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MBBS(Gold Medal), DNB(General Medicine), DM(Medical Oncology)(Gold Medal)
Medical Oncologist
Dr. Bharati Devi Gorantla
MBBS, MD(General Medicine), DM(Medical Oncology)(Adyar,Chennai), ECMO, MRCP SCE(UK)
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Dr. Owais Mohammed
MBBS, MD (General Medicine), DrNB (Medical Oncology), ECMO, MRCP SCE (Medical Oncology) (UK)
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How does the consent process work, step by step?
Information meeting
Your oncologist or trial coordinator explains the study. You receive a written patient information sheet to take home.
Time to think
There is no deadline to sign on the same day. Read the document at home, share it with family, and come back with questions.
Questions answered
Bring everything you want to know — including whether a placebo arm exists and exactly which costs are covered by the sponsor.
Signing
If you agree, you and a witness sign the informed consent form. You receive a copy to keep. Your signature is not a commitment to complete the trial.
Treatment begins
The protocol starts. Monitoring is more frequent than in standard care — more clinic visits and blood tests are usual, and most are covered by the sponsor.
Ongoing consent
If the protocol changes or new safety information emerges, your team must inform you and obtain your agreement before continuing.
Are cancer trials as risky and expensive as I fear?
| Concern | What patients often expect | What actually happens in India |
|---|---|---|
| Placebo | Getting a sugar pill instead of any treatment | Cancer trials rarely use placebo-only arms; ICMR prohibits it when an effective treatment exists for your cancer |
| Cost | Paying for an unproven treatment out of pocket | The trial drug is paid by the sponsor; you do not pay for the experimental medicine |
| Leaving | Losing your doctor or care if you withdraw | You can withdraw at any time; your oncologist continues your standard care without interruption |
| Risk | Being exposed to unknown dangers without warning | All known risks must be disclosed before you sign; your safety is monitored throughout the trial |
| Control | Having no say once you have signed | You can ask questions, raise concerns, and withdraw at any point — your consent is not a final commitment |
Did you know?
Under CDSCO regulations, trial sponsors in India are required to provide compensation for any injury or death directly caused by participation in a clinical trial — without the participant having to prove negligence.
This protection applies to every regulated trial conducted in India, regardless of who is funding it.
Source: CDSCO Good Clinical Practice Guidelines for Clinical Trials in India
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Common questions
Frequently asked questions
Will I get a placebo instead of real treatment?
Almost certainly not in a cancer trial in India. ICMR guidelines prohibit placebo-only arms when an effective treatment already exists for your cancer. If a trial does include a placebo arm, your consent document must state this before you sign, and you must still receive standard care alongside it — never instead of it. The consent form will also tell you the probability of being assigned to each arm. If no placebo arm is mentioned in the document, there is none in the trial.
Do I have to pay for the trial drug?
No. The experimental medicine is paid for by the trial sponsor — a pharmaceutical company, institution, or government body running the trial. Your routine standard-of-care medicines and some monitoring may still carry normal costs. Ask the trial coordinator before you sign which costs are covered and which are not, and ask for a written summary. CDSCO regulations also require sponsors to cover the cost of any medical care needed to treat a trial-related injury.
Can I leave the trial if I change my mind?
Yes, at any time and for any reason. You do not need to explain yourself to the trial team. Withdrawing does not affect your relationship with your treating oncologist or your access to standard care — your doctor continues to treat you. Medical data collected up to the point you leave may still be used in the study analysis; the consent form explains this. No new data is collected after you withdraw. Informing the trial coordinator in writing is helpful, but a verbal statement is also valid.
What risks do I need to understand before I consent?
The consent document must list all risks known at the time you sign — common side effects, rare but serious ones, and anything not yet fully characterised if this is an early-phase trial. Ask your oncologist to explain any risk you do not understand. Ask specifically which risks are most relevant given your own health history, the other medicines you take, and your current fitness. If new risks are discovered after the trial starts, your team must inform you before you continue.
Will my normal treatment continue if I join a trial?
Yes. Most cancer trials are designed either as an addition to standard treatment or as a direct comparison against it. Joining a trial does not mean giving up the treatment you would otherwise receive. If the trial treatment stops working or causes significant side effects, you return to standard care without delay. Your oncologist remains your primary doctor throughout — the trial team works alongside them, not instead of them.