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. But patients who are well-informed and feel empowered and supported are more likely to join and fulfill their commitment to a clinical trial—a requisite to bring new drugs to market.
To better understand and 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 for improving how participants are empowered, informed, valued, and supported throughout the trial process. These recommendations aim to increase the likelihood that each stakeholder will contribute 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 they have a deeper understanding of patients’ lives than other professionals involved in the study. Our interviews found these coordinators often see themselves as passionate protectors of patient interests and many patients echoed this view. For instance, a number of older patients told us 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 said some tools provided by pharmaceutical company sponsors, 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.
Trial participants frequently feel 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 clear information can make patients feel more like equal partners, boosting recruiting efforts and sustained enrollment.
For patients whose illness impacts their well-being, career, and daily life, knowing 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.
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.
Make the up-front investment
With growing levels of mistrust for institutions of all types, life sciences companies need to bring new skills to recruiting, retaining, and engaging trial participants. This might require more collaboration between trial designers and corporate marketing and communication specialists, especially those experienced in communicating with specific demographic groups.
Also, remember to interview those patients who did not join or stay with a trial. Their feedback can provide some of the most valuable insights into ways to improve the patient experience.
These changes will not be easy or inexpensive. But they are essential for meeting the needs of patients and the drug development process in a decentralized, digital, post-pandemic age.