Life in general can be challenging for patients, and taking part in a clinical trial is often physically and logistically intrusive. This can lead to feelings of isolation, depression, and anxiety.
Participants sacrifice a great deal to take part in clinical research, and it can put a lot of pressure on them and their lives – especially if they’ve been unwell for a long period of time.
While patients’ physical health has always been a key focus for medical practitioners, the impact of mental health for patients taking part in clinical research hasn’t, until relatively recently, been high on the agenda.
The COVID-19 pandemic has highlighted mental health in general, as complaints of loneliness – which has known links to other health risks – have risen among the public during lockdown. These issues are similar to the ones we see in patients, and the clinical research industry must look more carefully at the impact of mental health on patients taking part in clinical trials.
Here, we put participant mental health under the microscope. We’ll look at why it matters, and the impact of excluding patients with known mental health issues from clinical research. Then we’ll explore what researchers can do to prioritise mental wellbeing among participants taking part in clinical trials.
Why does looking after patient mental health matter when it comes to clinical trials?
Mental health may be a deciding factor in trial recruitment and retention
Understanding what’s going on in the patients’ world during the research journey may help pharma and CROs (Clinical Research Organisations) with participant recruitment and retention.
In our mdWebinar, ‘How Can We Improve the Patient Experience in Clinical Trials?’ co-founder and chair of FibroFlutters, Carole Scrafton, said: “There are lots of costs involved [in clinical trials], and I’m not just talking about money for getting to places and staying places. There’s a lot of physical cost and mental cost that also goes into it.”
We’ve discussed before how socioeconomic factors can impact willingness to participate in a clinical trial. However, once a participant is enrolled, the issues previously impacting their lives won’t disappear. In fact, the added pressure of the trial, as well as any associated costs, could have a significant impact on their mental health.
Rhonda Henry, VP, Patient Centered Trials at PPD, pointed out in another mdWebinar: “If we are going to plummet into a recession or if the patients are worried about the financial situation, or they might be looking for a job, maybe being part of a trial is not at the forefront of their mind.
“We really need to take in consideration the mental health aspect. What is going on in terms of the patient’s mind that might prevent them from being part of a trial?”
The emotional burden of disease is well documented, and adding the demands of a clinical trial may be too much for some patients to deal with. Chronically unwell patients can find constant clinical interference exhausting, and the intrusion of assessments is a key reason patients cite for dropping out of clinical trials.
Similarly, if trials continue to list ‘serious mental illness’ among their exemption list for eligibility, they will vastly limit the pool of available participants. This not only negatively impacts recruitment, it also causes issues around diversity.
Poor mental health among clinical trial participants could affect the outcome
The psychological toll of taking part in clinical trials is significant. Researchers should recognise that participating in a clinical trial involves more than simply receiving the appropriate treatment. It’s an all-encompassing experience for many patients.
It’s no surprise then, that such an experience could impact a participant’s mental health. But many researchers don’t consider the profound impact this could then have on reported side effects or even the outcome of a drug trial.
Carole Scrafton said in our mdWebinar: “If there’s a lot of pressure on [the participant] to be so compliant for instance, it could set off a bit of anxiety. The problem is, that little bit of anxiety adds a little bit of extra stress onto the internal body system. Now that could actually cause the results to alter. Again, because the effects of anxiety on the body are actually really quite strong.”
Researchers must monitor patients’ mental health if they don’t want to risk incorrectly recording side effects that can be attributed to the clinical trial process on the treatment itself.
The impact of excluding patients with known mental health issues on trial outcomes
While recording inaccurate side effects can be a byproduct of disregarding the impact of a patient’s mental health on a clinical trial, the opposite can also be true.
Historically, researchers have been able to run trials without having to worry too much about the effects of mental health – both in the lead-up and duration of the trial. Criteria may exclude patients who suffer from a serious mental illness, meaning a whole demographic with these conditions aren’t tested on.
Many clinical trials routinely exclude patients with depression, but this can have severe consequences. In the cases of Chantix and Acomplia, neither were tested on depressed patients, however, when those drugs were released to the public (and, inevitably, prescribed to people with depression), they led to a number of suicides.
By disregarding participants’ mental health, researchers could be recording side effects not caused by the drug at all, but the trial process. Or they could be missing vital side effects altogether.
How COVID’s impact on mental health is shaping clinical trials
Since COVID-19, consideration of mental health has been slowly gaining more prominence in clinical trials – but it’s still not as valued as it should be.
Now more than ever, mental health issues are at the forefront of the public’s minds. People know that isolation and loneliness can have a physiological effect on the body in line with smoking 15 cigarettes a day – because many of them have experienced the short-term effects for themselves.
Anxiety and depression are also on the rise, due to the pandemic bringing ongoing instability into people’s lives.
These factors impacting mental health are akin to the experience of many patients in hospital or people with chronic illness. Shielding methods for the most clinically vulnerable have also put them in an incredibly isolating and unstable position – which may impact their ability or willingness to participate in clinical trials.
For patients currently in clinical trials, COVID measures have meant face-to-face communication is limited. This increases anxiety among some participants – especially among the older generation, or a patient with sight difficulties – as trials lack the ‘human’ approach. Some trials have had to be postponed.
While the physical impact of COVID is clear, pharma and CROs can not ignore the impact that people’s general loss of wellbeing is having on the industry.
What can we do to improve the participants’ mental health in clinical trials?
Opening up conversations with participants can increase awareness of the links between mental health and clinical trial impact. Researchers should include a ‘mental health impact assessment’ on each element of the trial, where every behaviour change should be recorded and assessed – and the reason determined.
People are scared, and the situation with the pandemic remains uncertain, leaving a lot of patients in a difficult position. However, having those conversations between patients, CROs, sponsors and healthcare professionals will be a solid start in lessening the overall impact of mental health on trial outcomes.
Nurturing participants’ mental health is vital for your clinical trial
With mental health issues rising during COVID, researchers have no choice but to consider this impact on clinical trials, and support all of their participants accordingly.
By understanding external triggers for mental health issues, and extending compassion towards participants suffering from mental health problems, CROs will see a positive effect on attraction and retention in clinical trials. Likewise, including patients who are more diverse in terms of mental health will reflect positively on trial outcomes overall.
If our processes for recognising and looking after patient mental health were more robust and effective, then we wouldn’t need to exclude patients with known mental health issues. Instead, if we can accommodate mental illness, we can develop research that not only takes care of its participants but also results in a drug that is much more reflective of its real-world application.
Think remarkable. Expect remarkable. BE remarkable.
We deliver remarkable patient experiences that improve clinical trial outcomes.
We empower healthcare providers with next-generation care management tools and technologies.
We help CROs deliver high-performance patient experience management, and support pharma / biotech to attract, engage, and maintain patient participation in clinical trials.
Remarkable means the right people, the right technologies and the right systems to deliver the best possible outcomes for you, your patients, and your clinical trial.
Let’s make your next study remarkable. Contact us now to discuss how.