What Happens After The Trial Is Over? Post-trial Access And Post-trial Care
A concern of yours we’d like to address today is contained in the question “What next?”. What happens after the clinical trial is over, is a valid enough enquiry even if you end up deciding not to participate in one.
After a clinical trial is over what most of you want to know is whether now you’re entitled to the investigational drug or procedure if it proved to be beneficial to you. But post-trial care doesn’t end there and transitioning from the clinical trial to the world of established medicine is a process in and of itself.
Now, to get one thing out of the way: the short answer to the question “What kind of care can I anticipate once the trial ends?” is “It depends on the trial”. Sure, there are laws and regulations about it but they’re so vague and inexplicit as to be relevant to a various number of cases.
When talking about post-trial responsibilities, the Declaration of Helsinki’s paragraph 34 springs to mind. The Declaration itself addresses ethical principles of research on human subjects, but paragraph 34 specifically talks about post-trial provision and it says:
“In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”
Sounds pretty clear, huh? Well, not so much. The debate about post-trial access to treatment as well as post-trial care in the process of transition from the investigational drug to approved treatment options is still going on precisely because there are so many different cases and outcomes that cannot be foreseen.
For example, not all participants are equally as challenged in finding an effective treatment after the trial ends. Some of them have better chances than others because they have medical insurance or they have been previously able to manage their disease to some extent.
On top of that, some other ethical considerations emerge. Providing post-trial access to treatment or even post-trial care in the form of financial aid or social services creates a disparity between patients who have participated in a trial and those who weren’t lucky enough to do so but are also in a disadvantageous socio-economic situation.
The notion of ‘benefit’ can be questioned as well. Often, it is difficult enough to estimate and quantify to what extent the investigational treatment provides more benefit for patients than an already established one does. This is the reason clinical trials are conducted in the first place and also why it takes years for researchers to assess the potential of a new treatment. Hence, why such a thing as post-approval trials exist.
The question arises: is it ethical to prolong exposure to the investigational treatment if other similar treatments exist and their safety has long been established? It’s also important to consider this question in the appropriate context – the extensive monitoring participants undergo during the clinical trial is no longer in place once the trial ends.
These and many other considerations make it so hard to adopt universal guidelines and regulations regarding post-trial access, hence why the answer to your very particular question is: it depends.
Apart from post-trial access to the investigational treatment, what are the responsibilities of the people involved in conducting the clinical trial? Sadly, there is no exact answer to this question either.
Even if the participant did not benefit from the drug in development, doing nothing for them after the trial ends doesn’t sit well with most people. Responsible transitioning of participants from a trial to other forms of medical care is especially important for patients in a vulnerable state – those from developing countries, marginalised communities, lower economic status as well as those who do not respond well to existing treatments.
It’s imperative to distinguish between post-trial access and post-trial care, also called responsible transition, because not providing the former should not mean disregarding the latter too. For example, in cases when the ethical concerns against providing post-trial access outweigh the benefits of doing so, the patient nevertheless should receive some kind of post-trial care, especially if their well-being depends on it.
Post-trial care furthermore prevents the exploitation of vulnerable demographics in research. When participants have no other means of access to healthcare outside of research, responsible transitioning makes sure their disadvantage is not being exploited with the intention of creating a larger sample.
Now, to the question we’re sure you already have: what kind of post-trial care you’re entitled to depends on the given trial you’re considering and it’s described in the study protocol. There you should also be able to find an answer to all of your post-trial access questions as well.
If you’re considering joining a clinical trial, apart from doing a quick search on FindMeCure you also want to conduct your own investigation and gain as much information as possible about the particular trial you’re interested in. Always keep in mind that you can withdraw consent at any given moment and you are entitled to any information you need in order to make a decision.