The clinical research community has lately been advocating for a more patient-centric approach to clinical trials. Treating patients as research partners has many advantages, one being that patients will feel valued, which can in turn result in retaining those patients through study completion.
Overcoming retention issues in clinical research is ongoing, and putting patients first is a logical means of achieving this. But a patient-centric approach is also indicative of a shift in the industry, in which patients are treated with greater dignity and respect and shown how their contribution matters to medical progress.
Communication during the trial is vital to engage patients and keep them in the loop, of course, but there is great need also to maintain contact even after the trial ends. In this post, we explore the benefits of engaging patients after trial completion and how best to go about it.
From a young age, we’re primed to say thank you, yet patients feel researchers don’t thank them often enough. This was one of the findings Pfizer reported from post-trial research, according to an editorial in Nature Research. Patients just wanted a bit of appreciation for the time, emotion and energy they devote as participants in clinical trials and thus to medical science.
A logical conclusion then is that patients would welcome post-trial communication. And doing so could be a clever strategy for sponsors to enhance relationships for future research by promoting their good name on patient forums and among patient advocacy groups.
Indeed, saying thank you could be one of the easiest yet effective communications with patients at the end of a clinical trial. Laura Saxon at Couch Health Communications goes so far as to argue that saying thank you could be the most human response to patients giving up so much of their time, which is often from a desire to find a treatment for their own condition but also to help others.
Affordable gifts, thank you cards or letters would be effective means of delivering the message of earnest gratitude to trial participants, their families and caregivers.
It turns out that expressing gratitude in a thank you note is not only advantageous to the recipient but the sender too. In a study of the effects of sending thank you notes, John Templeton Keller professor of behavior science Nicholas Epley and Amit Kumar, assistant professor of marketing and psychology at the University of Texas at Austin, say the likelihood of expressing gratitude isn’t societal.
"It's more fundamental to how the human mind works and a well-established symmetry about how we evaluate ourselves and other people. When we're thinking about ourselves, we tend to think about how competent we are, and whether we are going to be articulate in how we're expressing gratitude."
When a trial finishes, patients can often experience a feeling of uncertainty. They could also be anxious about the loss of contact with the medical team. This is why the team at Lymphoma Action notes the importance of end-of-treatment appointments between patients and their medical team. During the session, the medical team should do their best to answer any questions from the patient and tend to their needs.
This meeting should end with a document for patients to consult, complete with the information about their condition, treatment, expected long-term effects and relapse symptoms to watch for.
They can also ensure patients have access to local support groups and counselling in addition to wellbeing events such as workshops and condition-specific exercise classes.
A useful way of thinking about clinical research is that it is being carried out for, with and by patients and the public, rather than research being something done to them, says the team at the National Institute for Health Research.
Strategies to ensure this collaborative approach include asking patients for feedback on project materials, study design and recruitment strategies, while also involving them in research advisory groups and reviews.
Even if a trial drug proves unsuccessful, patients should be kept in the loop when the trial is over. This indicates that their contribution was appreciated and is valued regardless of the result, European Patients’ Academy fellow Dominique Hamerlijnck explains.
Patients are aware that trials adhere to strict health and safety regulations, but they are still putting their health at risk by participating, she adds. The least they can receive in return is acknowledgement throughout the trial, including at its completion, as well as explanations as to why they are required to undergo certain tests, fill out forms and visit sites.
Communicating with patients after a trial ends points to a larger issue of patients not having access to data from trials in which they’ve participated. The 2018 Declaration of Helsinki, for instance, states that sharing trial results with the public is a researcher’s ethical duty.
Consider Amber Sapp’s case, examined by Heidi Ledford in Nature. Sapps discovered her 12-year-old son’s clinical trial had failed — not from the researchers and sponsors — but by browsing Facebook. “Every four weeks for two-and-a-half years, she had shuttled Garrett to a hospital nearly six hours away,” writes Ledford. “But an early data analysis, Sapp learnt, had shown that the treatment wasn’t working.”
Some pharma companies are getting wiser about the need to maintain communications with patients after trials. After all, they are a wealth of information when it comes to improving trial design. Admittedly, this feedback is often accessed via patient advisory or advocacy groups but it’s an important channel to keep live.
Post-trial communication might best be thought of as the third in a four-step process. The team at CISCRP argues that after the first two stages of informed consent and patients’ last visit, when patients should be thanked for their contribution, post-trial outreach is required.
This third step ensures continued engagement with patients through scheduled and periodic updates about the trial’s end date and the ultimate delivery of the trail summary reports, which is the fourth and final step.
Reaching patients requires the right approach, regardless of which stage of the trial the communication takes place. For instance, 74 percent of 50-65-year-olds use their smartphones to connect with others and access information explain Carol J. Peden and Leslie Saxon at the University of Southern California. Adults over the age of 65, this rate drops to 42 percent.
Worth considering, they warn, is that much of the digital technology being developed comes from young people working in startups. The concern here is that those young professionals may not the best judges of the needs of the chronically ill, older people or those without education and in lower income brackets.
To overcome this, digital health tools need to be created with trust, access and digital literacy in the minds of the developers. Additionally, on-demand services such as availability of medical information, real-time diagnostics, and communication with medical teams are essential to make patients feel valued and empowered.
Regardless of the medium used, sponsors should keep trial messaging simple and clear. Julie Lorraine Darbyshire and Hermione Clare Price at BMJ refer to guidelines from the Centers for Disease Control and Prevention that say information should include images and pictures, as well as easy-to-read text.
Sharing information should also happen in a timely manner, they note. Communication with patients about the outcome of the research shows respect and acts as a means to encourage the broader community to participate in research in the future.
Digital tools make communication with patients and patient advocacy groups much more efficient and effective than traditional options, but more can be done to make these conversations meaningful. After all, this is how patients can communicate with medical experts and fellow patients, seeking information as well as first-hand trial experiences, according to SCORR Marketing’s Anne-Marie Hess and Lindsey Wahlstrom-Edwards from Antidote Technologies.
Part of this improved communication means using all the tools available, such as message boards and online communities, the pair explains.
Throughout the trial process and after completion, communication with patients should aim to educate and support them. This means sharing medical knowledge, expertise and skills to manage their condition, says Harry Kirschner at Getwell Loop.
Achieving this type of empowering communication requires researchers to develop personalized content for patients, while at the same time providing a diverse offering of care plans for patients to use outside of the clinical setting.
Communicating with patients isn’t just a sign of respect and a potential boon to future research, it’s also a worthwhile investment.
Indeed, putting money into patient engagement activities can lead to a 500-fold increase in ROI, writes Tessa Richards at The BMJ. The earnings come from eliminating aspects of trial design and protocol plus improved recruitment and retention rates in trials.
Indeed, patient engagement can benefit sponsors’ reputation and their ability to connect with broader patient communities for future research as a result. There’s also a clear ROI derived from patient feedback through better designed trials. But more importantly, communication with patients after trial completion, especially when filled with gratitude, shows patients how valuable their contribution to clinical research has been and gives them the respect they deserve.
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