Clinical trials are the foundation of advancements in medical treatment but remain one of the pharmaceutical sector’s most challenging and costly processes. Trials are marked by critical issues such as low patient retention, low recruitment, countless inefficiencies and rising costs in drug development. In fact, 90% of patients surveyed would like to participate in medical research, but only around 3% of patients ever do, while one in five investigators fails to enroll a single patient into their trials.
The following numbers show that patient engagement is clearly a challenge.
of all trials are discontinued because of poor patient retention1
have become nonadherent to investigational medical products after 150 days2
3 OF 10
patients drop out of clinical trials3
We believe that a fundamental contributor to the challenges of patient engagement and retention faced by the sector is a faulty perspective. Traditionally, clinical trial experiences and recruitment processes have been designed around the investigators and the pharmaceutical teams behind them. This inside-out way of thinking neglects a central element of the equation: the patient.
That’s because when patients are linearly advanced through trials as experimental subjects, it’s easy to lose the human element that is so critical to success. To begin with, in most cases patients are not aware of potential clinical trials and their purpose. When they do attempt to participate, they’re often confused and frustrated by unclear eligibility criteria and trial procedures.
It's time to redesign the clinical trial experience by embracing a more patient-centered philosophy, one where patients are as informed, actively involved and invested in the process as investigators, sponsors and healthcare professionals (HCPs) are. Then, patient participation and retention would rise while dropout rates and costs would decrease.
Moving toward a participant-centric clinical development process could begin by surveying, investigating and understanding the needs and values of patients, investigators, sponsors and other stakeholders. The new process would successfully blend the interests of all of these major stakeholders.
While engaging stakeholders has been and continues to be the biggest barrier to optimizing clinical trials, a novel approach can be informed by similar successes in patient care and hospital treatment, as well as trends in consumer experiences beyond the healthcare realm.
How can we seize the moment and transform the participant experience?
Design a participant-centric clinical trial
Co-design clinical trials with participants who will validate the recruitment content, protocol design and trial design.
Recruitment for clinical trial
Target real participants' needs, uncovered by research and targeted analytics, and engage patients where they are in their health journeys, with their specific medical conditions in mind.
Enrollment & onboarding
Reduce barriers to entry and streamline processes by making content on eligibility criteria and informed consent clear, comprehensive and engaging.
Monitoring & adherence
Create a continuum pathway wherein each participant feels supported along the clinical journey. Design a UX (user experience) and UI (user interface) for a positive digital experience. Implement real-time monitoring and tracking.
Close out & handover
Create a clear transition path where relevant information is provided to HCPs and patients and ensure handovers between the investigator and HCP. Leverage technology to ease the transfer of research data and make clinical trial data accessible to patients.
Aggregate & validate data
Ensure secured and seamless capture of data and share the validations and insights with participants.
In order to truly transform clinical trials and drive medical advancements forward, we advocate putting the patient at their center. Every touchpoint is an opportunity to improve the overall experience. Focusing on the patient experience goes beyond simply thinking about disease factors; it’s about understanding a patient’s illness as well as their everyday life and empathetically viewing the effects of clinical trial interactions at every level.
By challenging assumptions, embracing experience-based knowledge and matching the needs of patients and researchers—in the set-up and design of research priorities, study design, information sharing and clinical trials overall—we can positively impact the success of ongoing and upcoming clinical offerings. Well-designed and aligned programs would boost enrollment, involve patients in the process and improve trial success rates and efficiencies. Alignment would also increase transparency and trust throughout. If something is broken, we must heal it: Reimagining ailing clinical trials is the first step in shaping a process that puts the patient first.
If you are an actor in the clinical trial experience and want to share your own experience or discuss the topic further, please do reach out.
1 Clinical trials and their patients: The rising costs and how to stem the loss. 2016. Available at: Pharmafile (Accessed: April 2019).
2 The Negative Financial Impact of Patient Nonadherence in Clinical Trials. 2017. Available at: Patient Recruitment Insights (Accessed: May 2019)
3 Clinical trials and their patients: The rising costs and how to stem the loss. 2016. Available at: Pharmafile (Accessed: April 2019).