Participants in clinical trials juggle their own responsibilities and obligations.
Just as their motivations for participating in clinical trials are various, so are the sacrifices they make to accommodate the trial. Further, clinical trials can take social and emotional tolls on participants.
Depending on the nature of a given trial, reimbursement alone might not provide participants with sufficient support.
This article intends to give a broad overview of some of the ways trial directors can design the participants’ material, social and emotional needs into a clinical trial.
The vast majority of the literature that speaks to the practical needs of participants focuses on finances. While this isn’t a participant’s only practical concern, it’s an important one and a good place to start this conversation.
For trial directors who intend to offer compensation, it’s worth thinking about how you will define what is a fair amount of money for participants. The team at Trialfacts has an excellent guide to compensation in which they offer four models of compensation:
Whichever model you choose, or whichever regulations apply to your trial, best practice suggests that participants be paid quickly. “While it is quite normal in pharma circles for payment terms to number 60 or even 90 days, such a wait is not practical for most study participants,” Amanda Burrell writes at pharmaforum.
An alternative to this is to simply pay for a participant’s expenses upfront. As Kyle Cunningham writes at MedCityNews, trial staff can book rideshares or taxis for participants and book lodging for them too.
“Programs that have implemented pre-paid participant reimbursement for trial-related expenses along with personalized travel arrangement (travel and lodging) have revealed a positive impact on patient enrollment and retention,” Cunningham writes. “In fact, these programs provide access to a broader and more diverse population, opening the opportunity for patients from varying socioeconomic backgrounds and locations to participate.”
Bioethicist Laurie Zoloth at the University of Chicago emphasizes too the importance of providing ad hoc treatment for things like side effects that participants might experience during the trial. After all, she notes, many insurance policies do not cover side effects from experimental procedures.
In 1983, researchers A.L. Kinmonth, M.K.M. Lindsay and J.D. Baum published the results of a study in the British Medical Journal concerning the social and emotional needs of diabetic adolescents who participate in clinical trials.
Unsurprisingly, their study found that school-age children struggle with things like diabetes management, exams and family emergencies as a matter of course. Adolescence is a complicated time, the authors note, and the presence of a medical condition only complicates that time further.
When selecting trial participants from this particular pool of candidates, the trial team will be unable to predict in advance which participants will experience any given social and emotional challenges. Therefore, the authors write, social and emotional support for all children and their families should be built into the trial’s design.
Now, expand the scope of the authors’ conclusions. All people — regardless of age, class or circumstance — will have their own unpredictable social and emotional challenges. Consequently, it’s up to clinical trial designers to ensure that social and emotional support are available to all participants. This will help ensure trials are accessible to everyone, and that participants will continue their participation during any of life’s challenges.
“[T]he industry recognizes that there is a strong need to get involved in patient support,” Accenture’s Órlaith Burke writes. “To not do so is equivalent to ‘an ostrich’s head in the sand’, according to the director of one multi-national pharma client interviewed during our research.”
That interviewee, Burke writes, recommends that clinical trial organizations facilitate the building of communities to not only support participants but to also increase the brand value of those organizations.
Again, this is a place where patient advocacy groups can and do play an important role. Juliet Moritz, COO of the Illingworth Research Group, tells Outsourcing-Pharma.com that patient advocacy groups are a key component in patient-centric clinical trial design.
These groups can provide a social network for people — a place where people with a given condition can share empathy — and they can help clinical trial teams design their trials to be more inclusive of specific patients.
Finally, it’s important to honor the motivations of participants who are trying to learn more about their own health or trying to contribute to the world’s medical understanding.
Clinical trial teams can help support these participants simply by ensuring those participants feel that they’re heard. This can be done by creating an ongoing feedback system in which you solicit participants’ observations and opinions.
“Creating an avenue for communication and continuous feedback enables ongoing dialogue and interaction at the site and patient level to increase awareness of trial items through the trial lifecycle,” Michael Keens, COO at Firma Clinical Research, writes. “Establishing and nurturing this ongoing feedback allows more rapid response to feedback, increases trial efficiency, and demonstrates a higher degree of overall trial engagement.”
In January 2020, a study published in Therapeutic Innovation & Regulatory Science made the case for sequential patient-experience surveys (PES), or surveys sent to participants throughout the trial, not just at the end.
“Deploying PES at multiple time points during a clinical study may help sponsors better understand how to improve the study processes that are most important to patients at each stage,” notes the article, whose first author was UCB’s Elizabeth Manning. “Moreover, global PES deployment is possible, provided that operational challenges and cultural differences are addressed appropriately and proactively whenever possible.”
Then, at the end of the trial, it’s worth exploring whether and how to give participants their own trial data for future use. Innovative Medicines Initiative in Europe has written about how to do so within the framework of the EU’s GDPR privacy laws. The initiative’s ongoing work seeks to create best practices and legal frameworks for personal data management across Europe, and then to create a prototype for delivering personal trial data to participants.
“[T]he project results should empower patients by returning their clinical trial data to them and to their medical records,” the team writes. “Data acquired during clinical trials will aid better shared medical decision-making and reduce duplication in procedures/investigations.”
Literature both from academia and the private sector demonstrates the importance of supporting clinical trial participants practically, socially and emotionally.
However, much of the practical needs discussed are financial. There has been significantly less research into the other practical needs that trial participants might have. These could include:
An interesting avenue for future research would be how any such services support participant recruitment and retention.
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