Clinical trials are essential to prove the safety and efficacy of drugs before they can be brought to market. Yet even before COVID-19 made it difficult or potentially dangerous for patients to visit clinical trial sites for study visits, researchers and clinical research coordinators often struggled to recruit and retain trial participants. In addition, healthcare professionals often fail to introduce the option of trial participation to patients, and struggle to navigate study protocols while providing routine care.
To understand and better meet the needs of all stakeholders in the clinical trial process, our Idea Couture team conducted hundreds of in-depth ethnographic interviews with patients and their caregivers as well as principal investigators and research coordinators who work with multiple global pharmaceutical companies.
Based on these insights, we identified critical considerations to improve how participants are empowered, informed, valued and supported throughout the trial process. These recommendations aim to increase the likelihood that each stakeholder contributes to speeding new treatments to market.
Patients who feel like true partners in the clinical trial process are more likely to join a study, stay involved and carefully follow protocols. Clinical research coordinators, study site managers and staff who manage day-to-day trial activities are more likely to offer their facilities for trials and work effectively with patients if they feel a connection with and sense of ownership in the research. Meeting these needs requires a nuanced understanding of how patients and research coordinators view their roles.
Clinical research coordinators manage day-to-day trial operations and engage with clinical trial participants at many study visits. They generally feel that they have a deeper understanding of patients’ lives than other professionals involved in the study. Our interviews found that these coordinators often see themselves as passionate protectors of patient interests. Many patients echoed this view: for instance, a number of older patients told us that it was the trial site staff who made the experience not only bearable but also pleasant, even amid issues such as transportation challenges or study-related complications.
Many research coordinators also claimed that some tools that pharmaceutical company sponsors provided, such as scheduling spreadsheets, appointment cards and data entry methods, are burdensome and intrusive, interrupting their workflow or ability to serve patients.
Patients often felt discouraged, having limited or no input into trial process timelines or the study visit structure, and expressed that they didn’t adequately understand the research protocols that determine how a trial is conducted.
Before the trial, review the study protocol with all key stakeholders including patients, caregivers and study site personnel, such as research coordinators. This demonstrates that the sponsoring company values their views, increasing their engagement in the study.
Understand and streamline site workflows, such as eliminating the need for coordinators to complete questionnaires by hand and online. This can increase compliance rates and show that the coordinator’s work and time are valued.
Trial participants frequently feel that they are treated like objects or research subjects rather than people. In one series of interviews, every patient we spoke with mentioned "not wanting to be a guinea pig" when they were invited to join a trial. More complete and clearer information can make patients feel more like equal partners, boosting recruiting efforts and sustained enrollment.
Clearly explaining to patients what each trial phase entails and why each step is important. For example, if the staff is no longer drawing blood, why is it important for the patient to still keep a daily symptom journal?
Consistently updating patients about their current status in the trial and what to expect in next steps and stages. For example, if they no longer must visit a clinic for a blood sample, does that mean that their role in the trial is ending, or just that the investigators are tracking other information?
Consider providing trial information in a low-stress environment (rather than at the end of a long hospital visit) and make it easily understandable.
Explore using short videos or games for younger patients. One mother reported that telling her elementary school aged son that he would use a typically off-limits iPhone to track his symptoms made his agreement to a pediatric treatment trial a “slam dunk.”
Provide trial information in the patient’s and caregiver’s native language. Avoid complex terminology and use a legible print size and clear layout, especially for patients with limited vision. Even better, pilot content with prospective study participants before general use. Making trial equipment and processes easy to use and even fun can pay big dividends.
When necessary, invest in real-time remote support (such as phone, chat or text services) for patients and caregivers. This is especially important for decentralized trials where much of the work is done at the patient’s home.
For patients whose illness impacts their well-being, career and daily life, knowing that they are contributing to a process that can help others can be a powerful motivator. But too often, pharmaceutical companies fail to share trial results with patients, especially when its benefits are not known until long after the trial ends.
After her trial, one patient told us, “… it was like, it’s the end of the story. They broke up with me … I guess I would have liked more follow-up or to know more results of other people.” A parent of a child in a trial said, “I wrote the name of this [trial medication] down and I’ve been asking about it. Every so often I would ask my pharmacist or look at the counter. And I never see it. So I don’t know what happened to that drug. I can’t even remember the name of it anymore.”
The lack of such follow-up is a lost opportunity to strengthen the trial’s value for the patient, reducing their likelihood to volunteer for another or suggest participation to fellow patients.
Share ongoing, detailed updates about how each patient’s participation helped other patients or further research, even if the other research is unrelated to the participant’s condition or is conducted years afterward.
Ensure that patients know they are receiving special care as a result of their participation, something many told us was a powerful reward. Even a special logo on advisory letters or emails, or sincere recognition from a receptionist or nursing assistant, can help reinforce this message.
Feeling connected with fellow patients reduces participant anxiety, helps prove the efficacy of the treatment and provides valuable support. When they feel such a connection, trial participants more readily assume roles as champions of the treatment, volunteering to share their positive experiences with others.
Understand who besides a patient’s immediate family will help them during a trial, and design education and support that meets their needs. This requires not only translating support materials into appropriate languages but also understanding cultural norms (such as the role that adult children are expected to play in their parents’ care) in designing protocols, training and support such as videos and chatbots.
Create support and training mechanisms that allow caregivers to learn from and support each other, such as online forums where challenges and advice can be shared.
Work more closely with the patient’s primary care physician to ensure that they are aware of the trial and the patient’s role. We found that patients who can turn to this trusted source of advice and support are more likely to join trials and have fewer concerns about them.