Before joining a clinical trial, how can you plan medication access and referrals after it ends?
When preparing to sign the informed consent form, ask the study doctor not only how the trial will begin, but also who will take over your care when treatment ends, your condition worsens, or you need to withdraw. If you plan to travel to China for treatment from another country, review medication supply, costs, and follow-up with your doctor where you live before you travel.
Key points
- Your last dose, the end of your individual follow-up, and the end of the whole study may fall on different days. Stopping the study drug does not necessarily mean withdrawing from all follow-up.
- Whether you can continue receiving the study drug after the trial depends on your condition, the study arrangements, and actual supply. Neither a registry entry nor a verbal answer guarantees continued access.
- Before you leave, have the receiving doctor confirm that they have received your records, agreed to take over your care, and arranged your next appointment. If this is not yet in place, ask the study doctor to help arrange care during the transition.
Before signing, clarify when and under what circumstances participation will end
Ask the study doctor and coordinator to mark in the consent form or a written explanation the expected dates of your last dose, end-of-treatment visit, individual follow-up, and closure of the study site or the entire study. Dates may change. A registry showing that a study is complete does not replace confirmation of your own follow-up arrangements.
Also ask what happens in each of three situations: you complete treatment as planned, your disease progresses or you develop side effects, or the study stops early. Ask the team to explain whether dosing will stop, which tests you will need, who will notify you, and how you will move to routine medical care. Do not stop or change your current treatment yourself. If you need to change medication or wait for treatment, the study doctor and your usual treating doctor should arrange this together.
What are the possible next steps after trial treatment ends?
Ask the study doctor to explain the possible options for your situation, then discuss them with the receiving doctor:
| Possible option | Questions to clarify before enrolling |
|---|---|
| Continue treatment under the original protocol | Who decides whether you are eligible to continue? How long will medication be supplied? What happens if your disease progresses, you develop toxicity, or the medication runs out? |
| Join an extension phase or another study | Will you need to be screened again and sign a new consent form? How will visits, tests, and costs change? |
| Move to routine treatment if the drug has been approved | Is it available where you will receive care, who can prescribe it, and what are the price and insurance coverage? Marketing approval does not mean local hospitals already have the drug. |
| Stop receiving the study drug | The receiving doctor should assess other treatments or supportive care. Ask when you should return for a visit and how to manage symptoms during the transition. |
The World Medical Association’s Declaration of Helsinki states that, before a trial begins, arrangements should be made for participants who still need an intervention to access one identified in the trial as beneficial and reasonably safe. Exceptions require ethics committee approval, and the specific arrangements should be disclosed during informed consent. This is a research ethics principle. Whether continued treatment is suitable for you, the route for obtaining it, and actual supply still need to be confirmed. World Medical Association
In China, a conditional expanded-access mechanism exists for some drugs that have not received marketing approval. Article 23 of the Drug Administration Law applies to drugs undergoing clinical trials for diseases that seriously threaten life and have no effective treatment. It allows these drugs to be used for other patients with the same condition within the institutions conducting the trials, if medical observation suggests possible benefit, ethical principles are met, and review and informed consent have been completed. This does not guarantee automatic continued access for original trial participants. Ask the institution to verify whether it applies to your circumstances. Drug Administration Law
You can send this message to the study site:
I am considering joining the study at [registration number, hospital, and campus]. What treatment arrangements would follow if I complete treatment, my condition worsens, I develop side effects, or the study ends early? Is there a plan for continued access to the study drug? Who assesses eligibility, how long would supply continue, and where would dosing and monitoring take place? If I cannot continue, who will help arrange a referral? Please provide a written explanation and contact details for the person responsible.
Article 8 of China’s current Regulations for Implementation of the Drug Administration Law states that drug clinical trial sponsors and clinical trial institutions must not charge participants fees related to the clinical trial. Regulations This provision cannot be assumed to apply to every type of research. Ask the site to explain in writing who is responsible for the costs of study drugs, study tests, care for adverse events, routine medical care after the trial, travel, accommodation, interpretation, and emergency care after leaving China. If you are unsure which costs fall under this provision, check with the relevant authorities. Confirm any time limits, claim conditions, and out-of-pocket amounts. Arrangements during the study should not automatically be assumed to continue after it ends; check the applicable rules and the site’s written explanation.
Can you obtain the medication after returning home?
First, tell the study site and your doctor where you live where you plan to receive care after returning home. For each medication you need to continue, ask both sides to confirm its name, how to take it, the quantity supplied at the final dispensing, the date that supply will last until, whether it can be obtained legally at your destination, who can prescribe it, and what documentation and monitoring are required. Ask separately about study drugs and approved drugs used in routine care. Do not assume the study site can ship medication across borders, and do not buy it yourself through unofficial channels.
Ask your doctor where you live to confirm whether they can see you, prescribe the medication, or arrange an alternative before your current supply runs out. If supply, approval, or an appointment cannot be arranged in time, ask the study doctor and receiving doctor to agree on a transition plan. Do not lengthen the interval between doses yourself. Requirements for carrying medication across borders or sending it by post vary by drug and country or region. Check separately with the authorities in both places, the airline, and the relevant healthcare institutions.
Before leaving, who should receive which records?
Ask the study team to prepare a handover summary for the receiving doctor. First clarify who will receive the records across the border and how they will be used, then send them through the hospital’s designated secure channel. At a minimum, include: the study name, registration number, and site contact; the intervention you actually received, the dates, and whether your treatment assignment is still blinded; current medications and changes; assessments of treatment response; unresolved adverse events, pending test results, and who is responsible for tracking them; your next tests, symptoms to report, and emergency contact details. Ask the team to explain any restrictions on reproduction, donation, or other activities. If you received cell therapy or an implanted device, also include product or device identification details and any applicable warnings. Keep the original medical records and imaging files. If needed, ask the receiving provider to confirm that the translations and file formats are usable.
Agree with the doctors on both sides which tests can be done where you live, who will review the results, and when they should be reported; when to contact the study team or local emergency services; and who will take over after the study site closes. The handover is in place only once the receiving provider has confirmed receipt of the records, understands what still needs to be done, and has arranged your next appointment. If you do not yet have a receiving doctor, ask the study team to help find one. Do not assume the original team can provide all your care remotely.
Frequently asked questions
The drug seems to be working for me. Can I keep using it free of charge indefinitely?
That alone does not establish whether you can. Ask the study doctor to assess the benefits and risks, and ask the site to explain in writing the eligibility requirements, duration, supply, and costs of continued use. Also prepare a plan in case you cannot continue.
If I want to stop the study drug, must I stop all follow-up?
Not necessarily. Tell the study doctor your decision and discuss stopping medication, in-person tests, telephone contact, and access to your medical records separately. You may withdraw without giving a reason and should not be treated unfairly because of it. Measures for Ethical Review of Research Please notify the study team as soon as possible so you can discuss stopping medication safely and the follow-up options available. Ask the team to explain follow-up options related to safety, and how data and samples already collected will be handled under the consent form and applicable rules. ICH E6(R3)
What should I do first if the study stops early?
Contact the study team. Ask whether recruitment, dosing, or the entire study has stopped, whether the reason affects your safety, and what arrangements are in place for your next tests and referral. If you develop severe or rapidly worsening symptoms, seek prompt medical care according to the emergency plan provided by the team.
Can I find out whether I received the study drug or the control treatment?
First ask when unblinding is planned and who will notify you. If this information is needed for emergency care, ask your treating doctor to contact the study team and follow the study’s emergency unblinding procedure. Do not assume immediate unblinding is available in routine circumstances.
How can I get my test results and the study results after leaving?
Before leaving, list your individual tests whose results are still pending, and record who will review them and when they will contact you and the receiving doctor. Separately, ask where the overall study results are expected to be published and how to update your contact details. Your individual results, treatment-group assignment, and overall study results may become available at different times.
What if I want to withdraw permission to use my samples or conduct future research?
Tell the study team exactly which permission you want to withdraw and request a written response explaining which samples can still be dealt with according to your request, and how data already used or required to be retained under applicable rules will be handled. The specific scope depends on the consent form and applicable rules. Do not assume all information already used can be deleted.
What if the receiving doctor says the records are incomplete, or the medication is temporarily unavailable?
Ask the receiving doctor to list the missing reports, required file formats, and latest date they are needed, and send this to the study site so it can provide them. At the same time, ask the doctors on both sides to agree on care until your next appointment or medication supply becomes available, including the interval between stopping one medication and starting another and possible interactions. Doctors should decide the specific plan. If the study site or sponsor does not respond, you can ask the site for contact details for the responsible investigator and the ethics committee.
Sources
Date checked: November 6, 2026. Study arrangements depend on the specific protocol, informed consent form, institution, and rules applicable in the relevant jurisdiction.
- World Medical Association: 2024 Declaration of Helsinki: Informed consent and post-trial arrangements.
- ICH E6(R3) Good Clinical Practice: Stopping treatment, withdrawal, follow-up, and data handling.
- Drug Administration Law of the People’s Republic of China: Articles 22–24.
- ClinicalTrials.gov: Study Information and Registration: Basic information on study registration and participation.