The following blog post was submitted by Cassandra Smith, Manager, Medical Research, Medical & Scientific Affairs, Bayer Inc.
In 2019, Center for Information and Study on Clinical Research Participation (CISCRP) published the results of a global survey on public and patient perceptions about clinical research. The study found that 62% of surveyed participants considered participating in a clinical research study to help advance science and treatments and 57% consider participating to help others who may suffer from the same disease (CISCRP 2019 Perceptions and Insights Study: Deciding to Participate). These altruistic reasons were the top two answers why patients consider research.
In observational studies in particular, patients receive no direct benefit by choosing to participate. Their anonymized medical data are collected, analyzed, and published – all with the intention of helping to advance science and ensure the safe and effective use of approved medicinal products. The contributions of patients may guide practice patterns, fulfill regulatory commitments, help secure product reimbursement, and change guidelines.
Thanking Patients: Introducing Patient Thank You Cards
As someone managing observational studies on the Sponsor side, I see how impactful real-world evidence is. The CISCRP Global Survey results resonated with me. If patients are volunteering to participate to help others, with sometimes no benefits for themselves, the very least we can do as the Sponsor of the research is thank the individuals for their involvement and participation. I must admit, I felt ashamed that I had never done this before for any of the studies I led.
To some, it may sound rather simple to send a thank you card. For others, there might be many questions very similar to those my study team had. What does the thank you card say? Who gives it to the patient? What does it look like? How can I ensure this is compliant? What additional work will our sites need to do? What feedback will the ethics boards have?
Designing the Card
Our starting point was the Clinical Trials Ontario (CTO) Participant Experience Toolkit. The toolkit contains helpful advice on how to thank participants participating in research studies. As a study team, we chose to send paper-based cards printed on cardstock, considering the accessibility of this medium to all participants. For our specific study population, we felt a printed card would be a more sincere expression of our gratitude.
We recognized the importance of ensuring the image on the front of the card was appropriate and meaningful for our study population and that the font size was easily readable. It took a few iterations before we finalized the material. The messaging was simple, limited to only express gratitude, and state the impact the patient’s participation would have – very similar to what would be found in the introduction to an informed consent form. Once our message was crafted, we had it translated into other languages to personalize the message.
As many Sponsors may also be able to relate, requiring internal approval on the cards was necessary before moving forward with the ethics board reviews.
The thank you cards were then submitted to the participating ethics boards for approval. This included sending to institutions and central ethics committees across the country. We were grateful that the ethics boards across the country were supportive of this material and we were able to maintain a consistent version of the card for all participating sites. To reduce burden on the site, we submitted the thank you card for ethics review at the same time as a planned protocol amendment. In hindsight, I would have included the thank you card in the initial ethics submission even if distribution of the cards would happen a bit later.
Distributing the Cards
Our study had already been enrolling patients for almost a year; however, we decided that we would initiate distribution of the thank you cards as the enrollment period was ongoing rather than waiting until the planned study end, which is planned for 2025. The patient’s agreement to participate in the study alone was enough for us to thank them. Further, we felt this provided the sites more flexibility in distributing the cards as this could happen at any of the future patient visits.
To maintain patient privacy, the sites were sent the thank you cards to distribute to patients. We thought it would be most meaningful to the patient if the card was signed by his/her/their physician and study nurse. The card acknowledged that it was sent from the entire study team at Bayer.
For Next Time
In hindsight, ensuring the creation and distribution of the cards was compliant and operationally feasible turned out to be less burdensome than I expected. I do not know if sending a thank you card made an impact for every patient. Regardless, I felt it important to try. I do hope the patients know how grateful we are for their willingness to participate in our study and advance treatment for future patients. With a bit of planning, the distribution of thank you cards was relatively easy. The next time I do this, I will prepare the cards at the onset of the study, even if we choose to distribute them at a later time. I would also like to explore how this could be done electronically for study populations who may prefer digital communication and to alleviate site burden. Following this experience, I can confidently say that I will do this for all the studies I have the opportunity to lead in the future.
CTO wishes to thank Cassandra Smith for sharing this blog as a part of #TalkClinicalTrials, a campaign led by Clinical Trials Ontario with support from many voices to build awareness of clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Read more of the #TalkClinicalTrial blog posts here.
About CTO’s Participant Experience Toolkit
In order to help clinical research teams make sure participants feel informed and valued, Clinical Trials Ontario worked with the community to create the Participant Experience Toolkit. The Toolkit provides guidance, considerations, and examples to inspire the clinical trials community to improve the participant experience. This toolkit was co-created with patients, participants, health charities, patient organizations, Research Ethics Board representatives, clinical research coordinators and industry representatives.