Resources & Training

Showing Patients an Attitude of Gratitude: Advice for Sites

June 1, 2023 infocusjune23 Resources

Modern medicine owes a lot to clinical trial participants. Patients give their time, energy, and often literal blood and other specimens to help find cures for today’s diseases and help speed drug development.

Yet, offering a “thank you” to patients is an inconsistent practice at best. Thirty-three percent of clinical trial participants report low satisfaction with their clinical trial journey, according to a 2022 survey conducted by TransCelerate BioPharma and the Center for Information and Study on Clinical Research Participation (CISCRP). In a climate where finding and enrolling patients as well as retaining them throughout a trial are common barriers to a successful trial, the simple act of showing gratitude to patients can make a positive difference.

Sponsors should design patient-friendly trials and equip sites with the tools to interact with patients in a meaningful way. To help address this, TransCelerate BioPharma recently released a Gratitude Toolkit to help stakeholders show appreciation to clinical trial participants and their care partners in ways that resonate.

Potential Benefits

The benefits of implementing gratitude into a clinical trial are multi-fold. It can:

Improve recruitment (via word of mouth) and retention
Improve a participant’s confidence in their clinical trial experience
Improve relationships between site staff and the participants
Demonstrate recognition of the challenges participants may be facing and may help support them in their clinical trial
Improve the reputation of clinical research
Improve a participant’s satisfaction and perceived value in their clinical trial journey
Improve engagement, adherence, and compliance
Help create a sense of community and a culture of gratitude

How Sites Can Have an “Attitude of Gratitude”

At the regional and site level, there are a few ways to demonstrate gratitude. For example, consider the cultural implications and appropriateness of different tactics and/or tools planned for the trial. Similarly, understand how local regulations and privacy laws may impact the implementation and roll-out of planned gratitude activities. Sponsors can consider how the planned tactics and tools will impact the sites. Is storage required? What does logistics entail and was training provided?

At the study level, be mindful of the patient population and consider what is meaningful or what would help them feel appreciated. This can be done through insights research or obtaining patient feedback. Personalize the experience for the participants and their care partners. Post-trial, evaluate the benefit and impact of the gratitude program to make any necessary changes to ensure value.

Some materials that can be in a site’s gratitude toolkit include:

Thank You Cards or Letters

A greeting card can be mailed from the study team to thank the participant for their participation, no matter the level. A card template with customizable text provides a personal way to show appreciation and gives the study teams the ability to adjust language in the thank you cards for increased personalization.

These activities should not be applied solely to the participants that are currently in a trial. For some studies, 30 to 70 percent of participants of clinical trial volunteers may “screen fail.” While they may not be a fit for that particular trial, sending them a thank you card at this point in time could greatly impact their interest in future research. Inside the card, consider providing them with the rationale as to why the study is not appropriate for them; encouragement to look into other trials in the future; information on how to find other trials; an opt-in for those participants who do not enroll to be contacted for future studies. These “Do Not Enroll” versions of the card can be printed in bulk to make it easier for sites to mail to patients and their caregivers.

Milestone Certificate

A milestone certificate can be given to study participants at relevant study milestones to remind them of their progress in the study. They can be given at the beginning, middle, and end or sites can adjust the cadence in relation to the length of the study.

Consider the distribution of these certificates as an opportunity for a personal discussion with the participant and their care provider on progress. While some may view a milestone certificate as “cheesy,” it prompts the site to take a moment to acknowledge the participant. The sites can have the flexibility to determine if it will resonate with a patient or not.

Note that when using a milestone certificate, it is important to be mindful of the indication. For indications where there are limited other treatment options or participants have likely exhausted all available treatment options, study milestones may not be viewed as celebratory.

Condolence Cards

When a patient dies while participating in a clinical trial, it is distressing and painful for the patient’s family as well as the site staff that has cared for the patient. Expressing condolence to a trial participant’s family is a gesture that may not be usually done on the part of the site staff due to possible uncertainty about what is to be communicated.

A personal, handwritten card can provide solace to a family in a difficult time. Express sympathy, use the patient’s name, and share that the patient made a difference by participating in the trial and that the study team is grateful. If a care partner was involved in trial visits or helping the patient while they attended trial visits, acknowledge their time.

Additionally, the trial outcome may be particularly important to some families. Consider an insert which includes the trial name and number. Offer the family an estimated date of when they can expect these results (approximately 1 year after the trial’s last patient last visit (LPLV) is completed for adult trials; about 6 months after LPLV for pediatric trials).

Flexibility

A patient-centric trial should accommodate for the individual and cultural preferences of patients. The best way to determine what tools and tactics are most relevant to a specific country/region and ensure inclusivity is by testing them with the target patient population prior to study start. Some tactics and tools may require adjustment in terms of timing, content, or may not even apply. For example, in some countries, “thank you letters” from a site are not seen as appropriate. In those countries, a “thank you card” may make more sense from a cultural perspective.

While TransCelerate’s toolkit includes materials for the entire process, sites need the flexibility to choose what works from them. Each trial is not a linear journey and the activities and emotions felt along the journey may differ from participant to participant.

Ultimately, the relationship and the sincere appreciation that participants want to see and feel is between the site staff and the participant. TransCelerate’s Gratitude Toolkit is a toolkit that sponsors (in partnership with sites) can leverage to acknowledge and show appreciation to clinical trial participants and their care partners. Often, the sponsor will create the materials and provide them to the site for use with the patient. When using the Gratitude Toolkit, TransCelerate recommends sponsors consider flexibility and collaboration with sites to allow sites to do what is best for their participants.

When in doubt, consider the impact of a simple verbal thank you. Today’s medicine would not be possible without clinical trial participants.

By Proof Clinical & TransCelerate

SCRS Stands Up for Low Income, Elderly, Disabled Populations

There is a lot of discussion about diversity in clinical trials. The “why” is clear – more representation is needed to assess the effects of treatment on different people, across race, sex, age and so on, including intersections therein. Diversity is required to benefit the science and progress our understanding of various drugs and treatments – determining how treatments work for biological males vs females, for example, or whether medicines tested in adults can be safely used for children. And of course, to enable clinical research as a care option for all. It’s the latter that I believe will move the needle to gain more patient participation. It is also a factor that requires a broader diversity lens that includes equity and inclusion. The crux of the complexity here is the “how” – how to go about increasing diverse representation. One could argue it starts early with study design and factoring in biological differences that could unintentionally result in excluding a diverse patient pool. Diversity is a Journey, not a Destination Forums like the recent SCRS Diversity Summit bring together sites, sponsors, CROs, and advocates to have meaningful conversations about moving the industry forward. When it comes to diversity, equity and inclusion (DEI), patient recruitment is an ongoing engagement and not a final destination. Education and awareness are ways to engage with local communities and build trust. Overcoming distrust doesn’t happen easily – and maybe not even within a generation in some populations. It’s a long-term commitment, which takes money, time, and effort. It’s no surprise, then, that during the SCRS conference sites consistently talked about the need for allocated DEI budgets and marketing support. This is requested on top of the usual trial marketing budget. DEI initiatives are primarily relationship-building activities. There is a worry that without sustained involvement in underserved communities, DEI efforts will be perceived as purely transactional to hit a recruitment target for a given trial. This is where research as a care option must foster a mutually beneficial partnership between patients and clinical studies – one that satisfies the need for research data while at the same time providing high-quality care for the participants. Lobbying for Greater Inclusion There are recognized systemic challenges facing equity and inclusion. To this point, SCRS champions action. During the conference, the team prepared a letter for people to send to their US congressional representatives to advocate changes that will allow more people to participate in clinical trials. In particular, the letter advocates for changes that support participation opportunities for low-income, elderly and disabled patient populations. The letter opens with: “Acknowledging health as a human right recognizes a legal obligation to ensure access to timely, acceptable, and affordable health care. Yet we continue to perpetuate health disparities through existing legislation that works for some but not all – especially as it relates to clinical trial access and diversity.” The letter highlights several actionable items to remove unnecessary friction for patients entering a clinical trial, such as: Making patient reimbursements non-taxable income Eliminating unfair hurdles that burden the enrollment of the Medicaid population Revising travel reimbursement to make it more equitable Allowing clinical trial sponsors to pay for Medicare beneficiaries’ co-pays and deductibles for routine care items and services required by qualifying clinical trials Simplifying the complex and inconsistent rules for the Centers for Medicare & Medicaid Services (CMS)  Legislation to Expand Research and Access to Treatment The letter requests to have the points above included in the Cures 2.0 Act, which expands on the 21st Century Cures Act from 2016. Building on the previous legislation, the Cures 2.0 Act now aims to fund research to cure challenging diseases like cancer and Alzheimer’s, as well as improve how new treatments are delivered to patients, with approaches such as: Increasing diversity in clinical trials with reporting requirements of trial demographics and recruitment campaigns targeted at underserved populations Requiring the FDA to improve the collection and use of real-world evidence Expanding access to new healthcare technologies to Medicare beneficiaries Making telehealth services more accessible for Medicare, Medicaid and Children’s Health Insurance Program beneficiaries Send the Letter to Your Congressional Representation More than 150 people signed the letter during the SCRS Diversity and Oncology Summits in Austin, including myself. You can find instructions on how to submit a letter to your US congressional representative on the SCRS resource page. By Kelly Brown, Chief Marketing Officer, Teckro

Accelerated Enrollment Solutions Joins SCRS Global Impact Partner Program

June 12, 2023 – The Society for Clinical Research Sites (SCRS) is pleased to announce the addition of Accelerated Enrollment Solutions (AES) as its newest Global Impact Partner. AES is a leading provider of patient recruitment and clinical trial acceleration solutions for the life sciences industry. The SCRS Global Impact Partner program offers industry sponsors, CROs, service providers and site networks an opportunity to align with SCRS’ mission of ensuring site sustainability while contributing to SCRS events, advocacy and educational opportunities for research sites. “On behalf of AES, we are honored to join the Society of Clinical Research Sites Global Impact Partner Program,” said Victor Lopes, M.D., vice president, medical operations. “Our business is committed to actively listening to and supporting the site community. We believe that serving as a Global Impact Partner gives us an excellent opportunity to contribute and enhance the relationships among sites, patients and clinical research organizations.” “SCRS is thrilled to welcome Accelerated Enrollment Solutions as our newest Global Impact Partner,” said Sean Soth, SVP of Global Business Partnerships, SCRS. “Their commitment to patient-centered recruitment and clinical trial acceleration aligns with our mission of advocating for the needs of clinical research sites and improving clinical research for all stakeholders. We look forward to collaborating with the AES team and sharing their expertise on how sites can improve patient recruitment, retention, and engagement in their clinical trials.” For more information about the SCRS Global Impact Partner program, visit scrsprograms.com/global-impact-partnership. About Accelerated Enrollment Solutions (AES) Accelerated Enrollment Solutions (AES), part of the clinical research business of Thermo Fisher Scientific, provides distinctive site solutions and patient enrollment to bring our customers greater certainty in clinical trial conduct. These solutions are available as discrete services or integrated to provide a cohesive and highly differentiated strategy for insourced or outsourced clinical studies, all under results-based commercial terms. We are committed to optimizing each step in the patient journey and delivering best-in-class site performance. About SCRSFounded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

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