How Thoughtful Communication Can Strengthen The Clinical Study Participant Journey

By Paula Buckley, VP of clinical operations, and Farrell Simon, chief commercial officer, Trevi Therapeutics

Effective communication is vital in recruiting and retaining clinical trial participants, and the limited pool of eligible and willing candidates for clinical trials escalates the critical need for successful communication initiatives from biopharma companies. Clinical operations professionals are responsible for fostering a trusted relationship with each patient, ensuring respect and understanding in every interaction. Particularly in the emotionally heightened environment of healthcare settings, this requires professionals to be extra attentive to the language they use with prospective and current trial participants. The patient journey in clinical development is voluntary, and communication can be the difference between acquiring a new trial participant and losing an existing one. In this article, we explore what we call the “participant journey,” addressing how to engage patients to become participants in clinical trials to further science and help answer clinical questions on the effectiveness of therapies in development. This process sits at the intersection of clinical operations, communications, and marketing to deliver thoughtful and compelling education to potential trial candidates. 

Importance Of Patients’ Personal Journeys And Clinical Trial Education 

Patients’ perceptions of clinical trials are a summative assessment of every experience throughout their own personal journeys. First impressions anchor these perceptions, acting as the foundation for a trustworthy alliance with participants. Communication with patients begins with trial sites preparing them for the initial discussion of the clinical trial. It starts even before a specific trial is introduced and covers general education about trials and their potential benefits. While sponsors are limited to communicating through trial sites, capitalizing on indirect patient communication methods is valuable to creating a positive patient introduction to clinical trials. Indirect sponsor communication methods include unbranded pamphlets, posters, and videos, which educate patients and clinicians on clinical trials. Trial sites can place these educational materials in waiting areas and patient rooms to facilitate patient and caregiver interest in clinical trials. Providing patients and caregivers with the knowledge of clinical trials allows them to deepen their understanding before the introduction of a specific clinical trial.¹ Sponsors need to ensure that the beginning of a patient’s clinical trial journey is based in clinical trial education to minimize confusion and anxiety around participation once a specific trial opportunity is introduced.

Slowly And Thoughtfully Introduce Information  

Site physicians should thoughtfully introduce patients to the option of a clinical trial before discussing their involvement. This demonstrates consideration from clinical operations and comforts patients during the prescreening process. These strategies can include sending an email, sending a physical piece of mail, or making a quick phone call to the patient stating there is a clinical trial in a particular indication that you would like to discuss at their next appointment. It is important to give patients adequate time to organize their thoughts and questions. Studies reveal patients who were not given advanced notice of the discussion of trials experienced more confusion with the presented trial information and less confidence in their understanding of involvement in trial procedures.² Sponsors can assist proactively by providing the local site with trial-specific information in the form of leaflets, emails, or videos, which the site can share with the patient. These materials are important to consider before the ethics submission process to ensure they are suitable for sites to share with prospective patients. With these materials, patients can review information independently or with close family members, furthering the conversation about their participation.

Receptive Listening And Patient Retention 

Participant retention is particularly challenging due to the voluntary nature of trial participation. Once a patient decides to participate in a trial, site staff should actively listen to make patients feel valued during the clinical trial. The relationship between patients and clinical professionals is strengthened when patients feel their experiences, concerns, and questions are truly heard and understood.³ By also being receptive to patients’ past clinical experiences, site staff can better adjust to patients’ concerns and demands, which is mutually beneficial to their experience and participant retention. The insights gained from interactions between site staff and patients could apply to a wider set of patients in a trial, assisting with overall communication. Sponsors should then provide any insights and learnings from their previous trials during the investigator meeting and allow open dialogue from clinical trial staff to share insights and previous experiences throughout the trial. Once the study is ongoing, continually learning and optimizing through feedback forums, such as advisory board meetings, can help determine any additional resources needed by trial sites and participants. These opportunities are also key moments for the sponsor to grow its relationship with the study site.

Adapt Communication To Each Patient And Caregiver 

Clinical trial communication efforts hold the ethical responsibility of solidifying patient comprehension of the totality of the study, their involvement, and their rights, risks, and benefits. This requires clinical professionals to be cognizant of the health literacy levels of each patient. The current success of health professionals matching patient’s health literacy levels is low, with studies reporting that fewer than 10% of patients understand the information presented to them by their health providers.⁴ To ensure that information presented on clinical trials is being understood by patients, all communication designed by sponsors for patient education and understanding should incorporate vocabulary that is commonly used and familiar to the patient population. Printed information should be written in layperson’s language and organized to be easily understood by the patient audience. Strategies to ensure clear communication include highlighting key terms, bulleting information into lists, shortening sentences to convey one idea at a time, and using visuals to expand upon written information when needed. Patients need to be confident in their understanding of clinical trial operations so that they feel secure and in control of their involvement. The use of medical jargon, acronyms, and complex medical terminology without clear explanation should be avoided, as it is more difficult for patients to process cognitively, leading to decreased comprehension. 

 Information intended to educate patients must be designed with the patient’s literacy level and cognitive needs in mind. For example, when conducting trial recruitment for an elderly population, informative written materials must consider any vision or hearing loss common in the population. Examples of adjusting for an elderly population include increasing the font size of documents to better serve their eyesight capabilities, emphasizing key components of information through the use of bold text or changing font color, reading the document with/to them to ensure they don’t skip over any lines of text, and increasing white space to create a less overwhelming experience. Additionally, adapting communication practices for specific populations or demographics can include talking at a louder volume level, slowing down your speed of delivery, repeating key ideas, explaining the purpose the presented information serves in the context of the trial, and providing them written recaps of the interaction.

Professionals should be sensitive to the auditory processing of each patient, adjusting speed and volume accordingly to maximize patient comprehension. Implementing silent pauses in between separate ideas, for example, can give patients time to further process the information and the opportunity to ask for clarification. It is pivotal that patients feel included in the conversation rather than feeling as though they are a passive audience of the speaker. To ensure patient understanding, clinical professionals should use open-ended questions that prompt patients to reiterate presented information in their own words. This allows clinical professionals the valuable opportunity to correct any misinterpretations and be assured that the patient is accurately informed. 

Patient-centered care asks professionals to adapt to the individual requirements of the patient. In clinical development, tailoring communication methods to patients and caregivers is pivotal to increasing the reach and retention of participants. Adjusting the main method of clinical trial communication to the one that the patient is most receptive to is important to ensure the correct understanding of information. Diversifying communication on digital, traditional, and mobile channels maximizes a company’s ability to adapt to the preferences of its patients and increases the total effectiveness of a company’s communications. To assure patients’ feelings of priority, sponsors should work with clinical trial sites to develop a list of contact information for patients to reference as well as establish a quick response time to patients’ messages.⁵ Providing a visit-by-visit guide to patients and caregivers is an effective method of preparing them for what to expect during the trial and when they can expect to hear from the study staff. Following through on set communication expectations and initiating an open line of continuous communication with patients will strengthen company/participant relationships and aid in trial participant retention.

Engaging A Global Community Through Communication 

Implementing marketing initiatives to aid public understanding of clinical trials is a proactive approach to engaging the global community in clinical trial activities. A health survey of United States adults reported that 90% had little to no knowledge of clinical trials.⁶ To increase public understanding, companies can utilize social media as a resource to broaden the reach of their educational content. When creating this content, it is important to recognize that social media users are hesitant to deem health information on social platforms credible. To avoid your educational content being perceived as untrustworthy, companies should acknowledge the credible source from which the information featured was pulled. For example: A study from [Source] stated [fact] OR by including the reference in the footer of the social media post. Research on the attitudes of trust in sources of healthcare information found that professional health organizations were the second most trusted source of information, with healthcare providers being the first.⁶ By directly citing trusted health organizations or government sources, companies can increase the efficacy of their clinical trial public education efforts. Developing public understanding of clinical trials allows more people to become advocates for themselves and/or loved ones to explore options for clinical trials. Studies on clinical trial recruitment report that 85% of the patients they interviewed stated they were unaware of the option to participate in clinical trials following their diagnosis.⁷ Of these individuals, three-quarters stated they would have been willing to participate if they had known. Public awareness initiatives to educate patients regarding why their participation in clinical trials is important will help increase the recruitable patient pool to support continued innovation across therapeutic areas.

Critical Last Impressions  

The theme of appreciation should be present in all clinical communication practices before, during, and after the conclusion of the study. The final impression of companies is just as vital to patient perception as the initial impression. The peak-end bias of judgment of experiences explains the tendency for people to subconsciously base their judgment of an experience on their very last interaction and their most significant memory.⁸ Considering this bias, continued communication efforts following the conclusion of a patient’s participation are imperative to solidifying a patient’s positive regard for their trial experience. To reduce clinical site burden, sponsors can provide a thank you note that includes information on where and approximately when trial results will be posted. This demonstrates the company’s appreciation of each participant. Participating in clinical trials is altruistic by nature, escalating the importance of showing appreciation for participants’ contributions to further clinical research.

Practicing effective communication that fosters respect and trust in clinical trials is essential to raising positive public awareness of a process that is critical to furthering science and developing effective therapies. The quality of the methods, delivery, language, organization, personalization, presentation, and listening efforts of clinical professionals is cumulatively responsible for shaping the perceptions of trial participants. Recruiting and retaining participants in clinical trials comes with a unique set of challenges, but by strengthening communication efforts throughout the entire trial process, sponsors can enhance the participant experience — boosting retention and encouraging future trial participation.

References:

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About The Authors:

Paula Buckley is the VP of clinical operations at Trevi. She has almost 35 years of pharmaceutical industry experience in analytical chemistry, quality assurance, and clinical operations. Before joining Trevi, Paula served as VP of Quality Assurance/Control at Penwest and held similar management positions in companies such as Bayer, Anesiva, and I-Health. During her tenure at Bayer, Paula worked in leadership roles in analytical chemistry in several therapeutic areas. She received her Bachelor of Science degree from Southern Connecticut State University.

Farrell Simon, Pharm.D./M.B.A. is currently the chief commercial officer for Trevi Therapeutics. He is an experienced general manager, previously working at Pfizer in commercial and operations roles, serving as chief of staff to the Biopharma Group President, and was a member of the executive leadership team. This leadership team managed $38B in revenue addressing the needs of patients in oncology, rare diseases, inflammation & immunology, primary care, infectious diseases, and preventative care with vaccines. Prior to Pfizer, Farrell gained general management, marketing, and medical affairs experience at Procter & Gamble. He is the founder and CEO of The Simon Cancer Foundation and is on the board of directors for the Greater New Haven Chamber of Commerce. He previously held positions on the advisory boards for the Business School and the College of Pharmacy at the University of Florida (UF). Farrell holds both an M.B.A. and a Pharm.D. from UF.