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A clinical trial is complete when the final participant’s last follow-up visit has occurred, and final data collection is complete. After this, the data are analysed and a final study report is written. This process can take several months, depending on the phase of the trial, the number of participants and amount of data collected, and how complicated the study was. During this time, participants may be wondering, “What happens to me now?”. In this article, we will discuss the following topics:
If you would like to know more about what happens during a clinical trial, read our Introduction to Clinical Trials blog.
Before you consent to participate in a trial, you are given a participant information sheet (and consent form) that tells you about the research study and explains how you will be involved – this includes what will happen to information about you.
Any information that can identify you will be treated as confidential and securely stored during and after a clinical trial. In addition, all participant study data is de-identified. This means that personal identifiers (such as your name and contact details) are removed from the study records and data and replaced with a participant ID or code.
Your personal information will only ever be used for the purpose of the research and will not be given to anyone else (such as employers and insurance companies) without your permission, except where required by law. If other people or agencies authorised by law are to inspect and review study records (for example, a clinical trial monitor or auditor), your privacy will be protected as required by law.
Your privacy will also be protected in any reports of the study, which may or may not be published or presented. This may include publication in medical journals, presentation at scientific conferences, and summaries of the study results posted online. Data must always be de-identified if it is to be published.
When a trial has finished, paper records may be moved to a secure storage facility. It is required by law that study records be kept for a certain length of time after study completion. For most clinical trials, records must be kept for at least 15 years. After this time records may be destroyed, or they may be kept for longer. In some cases, records may be kept indefinitely.
If the research team wishes to use your study information for any additional purposes after a trial has ended, they must explain this to you and obtain your informed consent before they may do so.
Ethical guidelines state that “All medical research subjects should be given the option of being informed about the general outcome and results of the study”. How you will be informed about the results of a clinical trial should be explained in the participant information sheet you received before starting the trial.
The results may be provided to you by the study team once they are released from the study sponsor by phone call, letter, or e-mail. You may need to contact your study doctor or coordinator to request the results yourself. In any case, your study doctor should receive a final study report from the trial sponsor, which may be shared with you upon request. If you do not completely understand the results, you should discuss them with the study doctor.
The results are usually presented as a summary of the outcomes of the whole participant group. It is unlikely that you will receive a copy of your individual results.
If you are not provided with the results, you might be able to find them online:
You should discuss the results with your study doctor if you do not understand them, especially when published in a medical journal.
Remember, it can take several months before the complete results of a clinical trial are available, and even longer before they are published in a medical journal.
In accordance with relevant Australian laws, you have certain rights to request access to information about you, however, there are exceptions and ethical guidelines that apply to disclosure of individual results in clinical trials. You should contact your study doctor to discuss any requests for access.
If information from a clinical trial arises that could be of significance to the health and wellbeing of you and/or your family, then your study doctor should have a plan for disclosing individual study results to you. When necessary, results may also be disclosed to other relevant people, such as your primary care doctor. This may include individual test results that are clinically important, such as blood tests and medical imaging.
A randomised controlled trial (RCT) is one in which participants are randomly assigned to receive either the investigational study treatment or a control. The control may be a placebo or an alternate treatment (for comparison). These trials are often blinded – meaning that participants don’t know what treatment they were given.
Many participants would like to know what they received when the trial is over. You might be told in person by the study team, or by phone call or letter. However, you may need to wait until every other participant has completed their final visit, or until the data has been analysed and reported. Sometimes, telling participants is not appropriate – if the trial is going to be extended, for example.
If it has been a few months and you would like to know but haven’t heard from the study team, you should call your study site. They might have to check with the study sponsor first.
If you found the study treatment helpful, you may want to continue using it. Whether this is an option or not will be explained in the participant information sheet provided to you before starting the trial.
There are two main ways in which participants might be able to continue study treatments that have not yet been approved for use in Australia:
There is also the chance that a clinical trial will be extended, allowing participants to continue treatment for longer periods. This allows researchers to evaluate the long-term effectiveness and safety of the treatment. Alternatively, if a trial only went for a short time, participants may be eligible to apply for future trials of the same or an “updated” version of the treatment. This is sometimes an option for participants in trials involving newly developed medical devices, for example.
Study doctors have an ethical obligation to provide or arrange post-trial care, whether a participant is eligible to continue study treatment or not.
This may include:
1. Bruhn H, Cowan EJ, Campbell MK, et al. “Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review”. Trials. 2021; 22(1): 361. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147098/
2. Cho HL, Danis M, Grady C. “Post-trial responsibilities beyond post-trial access”. Lancet. 2018; 391(10129): 1478-1479. https://doi.org/10.1016/S0140-6736(18)30761-X
3. ClinicalTrials.gov (NIH: U.S. National Library of Medicine): https://clinicaltrials.gov/
4. Di Blasi Z, Kaptchuk TJ, Weinman J, Kleijnen J. “Informing participants of allocation to placebo at trial closure: postal survey”. BMJ. 2002; 325(7376): 1329. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC137805/
5. Dorsey ER, Beck CA, Adams M, et al. “Communicating clinical trial results to research participants”. Arch Neurol. 2008 Dec;65(12):1590-1595. https://pubmed.ncbi.nlm.nih.gov/19064746/
6. Hudson KL, Collins FS. “Sharing and reporting the results of clinical trials”. JAMA. 2015; 313(4): 355-356. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101953/
7. Partridge AH, Winer EP. “Informing clinical trial participants about study results”. JAMA. 2002; 288(3): 363-265. https://doi.org/10.1001/jama.288.3.363
8. “Authorised Prescribers”. Therapeutic Goods Administration. 2022. https://www.tga.gov.au/resources/resource/forms/authorised-prescribers
9. “Chapter 4: Giving access to health information”. Office of the Australian Information Commissioner. 2019: https://www.oaic.gov.au/privacy/guidance-and-advice/guide-to-health-privacy/chapter-4-giving-access-to-health-information
10. “Guidelines Under Section 95 of the Privacy Act 1988”. National Health and Medical Research Council. 2014. Available from: https://www.nhmrc.gov.au/about-us/publications/guidelines-under-section-95-privacy-act-1988
11. “Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research”. National Health and Medical Research Council, Australian Research Council and Universities Australia. 2019. Available from: https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018
12. “National Statement on Ethical Conduct in Human Research 2007 (Updated 2018)”. National Health and Medical Research Council, the Australian Research Council and Universities Australia: https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018
13. “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories; Downey AS, Busta ER, Mancher M, et al., editors. 2018. Available from: https://www.ncbi.nlm.nih.gov/books/NBK525088/
14. “Special Access Scheme”. Therapeutic Goods Administration. 2022. https://www.tga.gov.au/resources/resource/forms/special-access-scheme
15. “WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects”. World Medical Association. 2013: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
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