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Clinical trials & access
Questions to Ask Before Joining a Trial — The Printable List, and Who to Ask Each One
For many Indian families a registered clinical trial is the only realistic route by which immunotherapy becomes reachable at all. That makes the questions harder to ask, not easier — nobody wants to interrogate the one door that opened. Ask anyway. This is the practical companion to the consent page: the twelve questions about the study itself, the questions about cost, travel, leaving and life after the study that the consent conversation usually skims, and which of the five people in the room is the right one to answer each. Information only. Nothing here recruits anyone into any study, no benefit is claimed for any investigational treatment, and no place on any study is offered or assured.
Medically reviewed by Dr. T. Raghavender Reddy, Medical Oncologist, MBBS · DM (Medical Oncology) · MD (Radiation Oncology) · Last reviewed August 2026
- Twelve questions about the study — Phase, arms, randomisation, comparator, study-only tests, risks, harm, alternatives, exit and end of study. Print them and take them in.
- The four nobody asks — Cost, travel, how you leave, and who looks after you when the study closes. These decide whether a trial is livable for your family.
- Ask the right person — Coordinator for logistics, investigator for the protocol, billing desk for money, ethics committee for concerns, your own oncologist for whether any of it fits you.
- Information, not recruitment — No study is named or offered here, no benefit is claimed for an investigational treatment, and signing is never the same as being enrolled.
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The direct answer
What Must You Ask Before Joining a Clinical Trial?
Twelve questions cover the study itself. What is being tested. What phase it is. How many arms there are and what each one receives. Whether a computer allocates you. Which tests exist only for the study. What the known risks are. What happens if you are harmed. What your alternatives are. Whether you can leave.
Nobody wants to cross-examine the team that just offered them a door. That is exactly why this list exists on paper. Print it, tick the questions as they are answered, and write the answers straight onto the participant information sheet. A study team that answers all twelve without hesitating is a good sign in itself — not because the answers are reassuring, but because a team confident in its protocol has nothing to manage around.
| Ask this | Why it matters | What a straight answer sounds like |
|---|---|---|
| What is this study testing, and what question is it trying to answer? | A study exists because the answer is not yet known. That is the definition of investigational. | The word “investigational” is used without flinching, and nobody tells you it will work. |
| What phase is it? | Phase 1 is mainly about safety and dose. Phase 2 looks for activity. Phase 3 compares against standard care. | A phase number, and a plain explanation of what that phase is designed to find out. |
| How many arms are there, and what does each arm receive? | You need to know the arm you could land in, not the one you hope for. | Every arm described, including the comparator, and what the comparator receives alongside standard care. |
| Is it randomised, and is it blinded? | Randomised means a computer allocates you. Neither you nor your doctor chooses. | A clear yes or no, and who knows which arm you are in. |
| If there is a placebo, is it instead of treatment or on top of it? | In cancer studies a placebo is usually added to standard care rather than replacing it — but you must confirm that for your protocol. | A direct answer for this study, not a general reassurance about trials. |
| Which tests, scans and biopsies happen only because of the study? | Study-only procedures mean extra needles, extra radiation and extra trips. | A specific list, and who pays for each item on it. |
| How often would I come, for how long, and for how many hours each visit? | This is the number that decides whether the study fits your working life and your family’s. | A written visit schedule, not “roughly monthly”. |
| What are the known side effects, and who do I telephone at 2am? | Immune-related side effects do not keep office hours, and a local casualty officer may not have seen one. | A named person, a working number, and a letter your local hospital can act on. |
| What happens if I am harmed by taking part? | Free medical management of a trial-related injury is your entitlement under the New Drugs and Clinical Trials Rules, 2019. | Who decides whether an injury was related, and that a registered ethics committee — not the sponsor — determines compensation. |
| What are my alternatives if I do not join? | This is the honest comparison the whole decision rests on, and it includes standard care and supportive care alone. | Real options named, calmly, with no pressure attached to the answer. |
| Can I leave, and what happens to my care if I do? | Participation is voluntary from beginning to end under the Declaration of Helsinki and the ICMR National Ethical Guidelines. | Yes, at any time, without giving a reason, and your routine care at that centre continues. |
| What happens when the study ends, or when I come off it? | The question families most often forget, and the one that hurts most later. | Whether the study drug continues for people still benefiting, who pays for it if it does, and who takes over your care. |
Ask for the participant information sheet, not only the signature page — they are two different documents, and the long one is where most of these answers live. This page is information only. It names no study, it recruits nobody, it claims no benefit for any investigational treatment, and no place on any study is offered or assured anywhere on it.
Did you know?
Every clinical trial conducted in India is required to be registered before the first participant is enrolled, and the register is public. The Clinical Trials Registry — India (CTRI), run by ICMR-NIMS, lists the sponsor, the participating sites, the study design and the eligibility criteria for each registered study. You are entitled to ask for the registration number and to read that entry yourself before you decide anything. If a study team cannot give you a registration number, that is the first question to ask, not the last. Registry entries are updated manually by study teams, so always confirm today’s recruitment position with the site itself.
The four nobody asks
What Should You Ask About Cost, Travel, Exit and Follow-Up?
Ask what the sponsor pays for and what still lands on you. Ask how many visits there are and whether travel is reimbursed. Ask how you leave and what stops when you do. Ask who looks after you once the study closes. Get all four in writing. These are what decide whether a trial is livable, and the consent conversation usually skims them.
| Area | Ask exactly this | Why families get caught out |
|---|---|---|
| Cost | What does the sponsor pay for, and what stays with me? Put it in writing. | The study drug and study-only tests are commonly covered. Bed charges, routine care, supportive medicines and management of complications frequently are not. |
| Cost | Is the treatment I would have had anyway still billed to me? | Families often assume a trial replaces every bill. It usually replaces one line of it. |
| Cost | What does the trial insurance cover, and what does it exclude? | Cover for a trial-related injury is not the same as cover for everything that happens to you during the study. |
| Cost | Can I still use Aarogyasri, CGHS, ECHS, ESI or my private policy for the rest of my care? | Scheme cover for the non-study part of treatment is often workable, but only if the paperwork is set up before you start. |
| Travel | How many visits, over how many months, and how many hours each? | Ask for the schedule on paper. A schedule you can put on the wall is a schedule your family can plan around. |
| Travel | Which visits genuinely need the trial site, and which could be done nearer home? | Some protocols allow local blood work. Many do not. It is worth asking rather than assuming. |
| Travel | Is travel or stay reimbursed, at what rate, on what proof, and how quickly? | Reimbursement that arrives three months later is not the same as travel being paid for. |
| Travel | What happens if I miss a visit because of a train, a flood or a festival? | Every protocol has a visit window. Knowing yours prevents a missed visit becoming a protocol deviation. |
| Exit | How do I withdraw, and what should I do first? | You may leave at any time without giving a reason. Speak to your treating oncologist first so the next line of treatment is ready. |
| Exit | What happens to the study drug supply, and to data already collected? | The supply stops when you leave. Data gathered before you withdrew usually stays in the study. |
| Exit | Does my routine care at this centre continue if I leave? | It must. A study team may not treat you differently because you withdrew. If that sentence is missing from the document, ask why. |
| Follow-up | Does the study drug continue for participants still benefiting when the study closes? | Some sponsors run a continued-access arrangement. Many do not. Ask before you join, not afterwards. |
| Follow-up | Who takes over my care when the site closes the study? | Names and a handover, not an assumption. This is where continuity is most often lost. |
| Follow-up | How will response be assessed, how often, and where? | At CION, immunotherapy is given as day care and response-assessment PET-CT is coordinated at partner imaging centres, not owned by us. Ask a trial site the equivalent question. |
No page can tell you the number for your study, and this one deliberately does not try. Any cost figure a site quotes you is indicative, as of August 2026, and must be confirmed in writing by that site before you sign. Nobody may charge you a fee, a donation or a facilitation payment to be enrolled — enrolment is not for sale in India.
The walkthrough
How Do You Actually Get These Questions Answered?
Eight steps. Print the list. Ask for a proper appointment. Take a second person. Put the practical questions to the coordinator and the clinical ones to the investigator. Look the study up on the CTRI yourself. Write every answer on the document. Then take the whole thing to your own oncologist before you decide anything.
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Print the list and put it in the folder with your reports
Take it on paper. A list on a phone gets closed the moment the conversation starts, and a list you can tick and write on is the whole point of having one.
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Ask for a dedicated appointment, not a corridor conversation
Say plainly that you have questions about the study and need twenty minutes. A study team that cannot find twenty minutes before you sign is telling you something.
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Take a second person with you
One person asks, the other writes. Nobody absorbs a protocol discussion alone in the week they first heard the word progression. Ask permission before recording anything on a phone.
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Ask the study coordinator the practical questions first
Visit schedule, hours per visit, which tests are study-only, what the site reimburses and how. The coordinator lives inside the logistics and answers those faster than anyone else.
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Ask the principal investigator the clinical questions
Phase, arms, randomisation, comparator, known risks, what happens if you are harmed, and what your alternatives are if you do not join. Those are the investigator’s to answer.
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Look the study up on the CTRI yourself
The Clinical Trials Registry — India, run by ICMR-NIMS, lists registered trials with their sponsor, sites and eligibility criteria. Entries are updated manually by study teams, so confirm today’s position with the site.
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Write every answer on the participant information sheet itself
Beside the question it answers, with the date and the name of the person who gave it. A consent conversation you can reconstruct a month later is worth ten you half-remember.
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Take the whole thing to your own treating oncologist, then decide
Your oncologist knows your histology, your prior lines of treatment and your organ function, and can say plainly whether this study is reasonable for you now, or whether it is not.
None of this has to be settled in one sitting. There is no rule requiring a consent form to be signed at the visit where it is handed over, and being told to sign today or lose the slot is a reason to slow down rather than to hurry.
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Go Through Your Question List With a Medical Oncologist
Twelve questions take about twenty minutes. Signing without asking them takes about two — and costs a great deal more later.
Direct the question
Who Should You Ask Each of These Questions?
Five people, and asking the wrong one wastes the appointment. The coordinator knows the logistics. The investigator owns the protocol. The billing desk knows what you pay. The ethics committee handles concerns. Your own oncologist is the only person who can say whether the study is sensible for you rather than good in general.
| Ask | About | Why them |
|---|---|---|
| The study coordinator | Visit schedule, hours per visit, which tests are study-only, what the site reimburses, what proof it needs, and how the paperwork actually flows | They run the logistics daily and will answer in minutes what takes an investigator a week |
| The principal investigator | Phase, arms, randomisation, comparator, known risks, what happens if you are harmed, and what your alternatives are if you do not join | The protocol is theirs. These questions are not answerable second-hand |
| The hospital billing desk | What you will actually be billed for the part of your care the study does not cover, and how scheme or insurance cover interacts with it | The clinical team estimates. The billing desk knows |
| The registered ethics committee | Any concern about how you are being treated, about pressure to sign, or about a compensation decision | Their contact details must be in the consent document. This is the number to use when something feels wrong |
| Your own treating oncologist | Whether this study is a reasonable option for you, now, given your histology, your prior lines of treatment and your organ function | Everyone else can tell you whether it is a good study. Only they can tell you whether it is a good study for you |
| Nobody outside that list | Agents, facilitators or anyone offering to secure you a place | No place on any study can be bought or assured, and being offered one is a reason to stop entirely |
Write all four contacts — investigator, coordinator, ethics committee and your own oncologist — on the front of the folder that holds your reports. The ethics committee number is the one you hope never to use and should always have.
Answers worth pausing on
Which Answers Should Make You Slow Down?
Six. Pressure to sign today. A promise that it will work. Any fee to be enrolled. No written visit schedule. No named out-of-hours contact. And no clear statement that you may refuse and keep your routine care. None of these means the study is a bad one. Each means stop and ask again.
- “Sign today or you lose the slot” — you are entitled to take the document home and to discuss it with your family and your own oncologist. Urgency applied to a signature is a reason to pause, not to hurry.
- Any promise of a result — an investigational treatment is under study precisely because the answer is not yet known. A legitimate document says a benefit is possible. It never tells you what will happen to you.
- A fee, a donation or a facilitation charge to enrol — enrolment is not for sale in India, and no place on any study can be bought or assured. Walk away from anyone who suggests otherwise.
- No written visit schedule — “roughly monthly” is not a schedule. Without it on paper, neither you nor your family can judge whether the study is possible from where you live.
- No named person and working number for out of hours — immune-related side effects can escalate quickly and do not keep office hours. “Come to OPD on Monday” is not an answer to that question.
- No sentence confirming your routine care continues — refusing a study, or leaving one, must not change the care that centre gives you. If the document does not say so plainly, ask the study team to show you where it does.
Signing is also not the same as enrolment. Consent gives the team permission to screen you, and screening can still end in a no — fresh bloods, imaging, sometimes a repeat biopsy, and every inclusion and exclusion criterion checked against your reports. Keep your existing treatment plan running in parallel so that a delay or a refusal at screening does not cost you weeks.
Before you sign anything
Print the List. Ask Every Question. Then Decide.
Bring the participant information sheet along with your histopathology, biomarker and imaging reports. We will work through what has been answered and what has not.
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Common questions
Questions Before Joining a Trial: Answered
What must you ask before joining a clinical trial?
Twelve questions cover it. What the study is testing and why. What phase it is. How many arms there are and what each arm receives. Whether it is randomised and blinded. Whether any placebo is given instead of treatment or on top of standard care. Which tests, scans and biopsies are done only because of the study. How many visits there are and how long each one takes. The known side effects, and who you telephone out of hours. What happens if you are harmed. What your alternatives are if you do not join. Whether you can leave. And what happens when the study ends. Write the answers on the participant information sheet as you get them.
What should you ask about the cost of a clinical trial in India?
Ask exactly what the sponsor pays for and what stays with you, and ask for it in writing. The study drug and the study-only tests are commonly covered; hospital bed charges, routine care, supportive medicines, management of complications and the treatment you would have needed anyway are frequently not. Ask whether the trial insurance covers a trial-related injury and what it excludes. Ask whether Aarogyasri, CGHS, ECHS, ESI or a private policy can still be used for the non-study part of your care while you are on the study. No page can give you the number for your study, and any figure a site quotes is indicative, as of August 2026, so get it confirmed in writing before you sign.
What should you ask about travel and visits before joining a trial?
Ask for the visit schedule on paper. How many visits in the first month, how many across the whole study, how many hours each visit takes, and how many of them genuinely require the trial site rather than a hospital closer to home. Ask whether travel or stay is reimbursed, at what rate, on what proof, and how long the money takes to reach you. Ask what happens if you miss a visit because of a train, a flood or a festival. For a family travelling in from a district, the visit schedule is what decides whether a trial is possible at all, and it is far easier to see that on paper than in conversation.
What should you ask about leaving a trial and what happens when it ends?
Ask both, because they are different questions. On leaving: you may withdraw at any time, for any reason or none, and your routine cancer care at that centre continues. Ask what you should do first, what happens to the study drug supply, and what happens to data already collected. On the study ending: ask whether the study drug continues for participants who are still benefiting, who pays for it if it does, how long that lasts, and who takes over your care when the site closes. Participation being voluntary from beginning to end is a founding principle of the Declaration of Helsinki and of the ICMR National Ethical Guidelines. The end-of-study question is the one families most often forget.
Who should you ask each of these questions?
Five people, and asking the wrong one wastes the appointment. The study coordinator answers the practical questions: visit schedule, paperwork, what the site reimburses and how. The principal investigator answers the clinical questions: phase, arms, randomisation, risks, alternatives, and what happens if you are harmed. The hospital billing desk confirms what you actually pay for the non-study part of your care. The registered ethics committee, whose contact details must appear in the consent document, is the place for a concern about how you are being treated. And your own treating oncologist is the only person who can say whether this study is sensible for you, rather than whether it is a good study in general.
What answers should make you slow down before signing?
Six. Being told to sign today or lose the slot. A promise that the treatment will work, when an investigational treatment is under study precisely because that is not yet known. Any fee, donation or facilitation charge to be enrolled, because enrolment is not for sale in India. No written visit schedule. No named person and working number for out of hours. And no clear statement that you may refuse and keep your routine care at that centre. None of these means the study is a bad one. Each means stop, write the answer down, and ask again with your own oncologist in the room. This page is information only and offers no place on any study.