Creating An Engaging Experience For Clinical Trial Participants
June 8, 2018
One of the biggest challenges faced by researchers today is the ability to recruit an adequate number of patients and to retain them for the duration of the study. The reasons for this inability are manifold and can range from having a protocol design that is too complex or eligibility criteria that are extremely selective, to factors such as poorly designed messaging for recruitment or a trial experience that is cumbersome for the participants. This challenge has led to the recognition that it is important to engage patients early in the process in order to incorporate their feedback into the design of the overall study experience. It is also beneficial to implement creative ideas and innovative platforms to help support the patient through the multiple steps involved in a trial, and to make the overall process an efficient one for them.
In a 2017 survey conducted by Applied Clinical Trials across a global sampling of sponsors, CROs, research sites and hospitals, it was observed that more than a third (41%) of the organizations did not perform outreach to obtain feedback from patients at all. For those organizations not having a defined strategy for patient engagement initiatives, lack of budget was reported as one of the major challenges to implementing such efforts. However, ensuring an engaging experience for research subjects not only facilitates patient recruitment and retention, but also optimizes costs and improves research outcomes, and therefore it is important that all stakeholders should consider having a well-thought out strategy around patient engagement for their entire research portfolio.
Recognizing the importance of ensuring that patients have a voice even in the stages involved with regulations and policy making, earlier this year, the FDA and Clinical Trials Transformation Initiative (CTTI) announced a joint effort, the Patient Engagement Collaborative (PEC), intended to engage individuals from diverse socioeconomic and demographic backgrounds to promote discussions around medical product development, incorporate patient feedback into the regulatory and scientific process, and assist in improving communications and programs that enhance patient engagement. This certainly isn’t the first initiative to encourage greater patient involvement. There have been others in the past – another notable initiative being the Patient-Centered Outcomes Research Institute (PCORI), started by the government in 2010, with the vision that “Patients and the public have information they can use to make decisions that reflect their desired health outcomes.” What is distinguishing more recent efforts among all stakeholders involved in clinical research is the greater use of technological innovations in creating a more interactive environment.
So what role can technology play and what are its advantages? Several approaches are being explored to improve patient engagement, some are highlighted below.
· Education and Support: Websites, Online Communities and Social Media
Patients today are more involved in their own healthcare decisions than ever before. A plethora of easily accessible information on the internet has led to a great awareness in the general population. With a wide range of socioeconomic and age groups involved in the research process, this awareness and access to information is by no means uniform, but increasingly the movement is towards one of having a broad patient population that is eager to be more engaged and actively involved in their healthcare choices. In addition to being more informed about their own choices, patients also serve as advocates and form support communities for others with similar conditions or treatment options. Online communities and social media is playing a big role in shaping how information is shared with patients. Being inclusive of patients even after the study has concluded helps to encourage participation in future research initiatives by them and their family and friends.
· Facilitating an Interactive Experience: Innovative Electronic Systems
A wide range of applications are being designed by technology vendors to help create a better experience for patients at multiple steps in the protocol lifecycle, and to ensure that they are an active participant in the process. Informative screening and consenting apps; electronic Patient Reported Outcomes systems; platforms that assist with activities like scheduling and medication adherence; and centralized recruitment systems that help perform outreach through targeted marketing programs; are only a few examples of how technology is being utilized in innovative ways to reach and engage the desired patient population in an effective manner.
· Efficient Communication: Mobile Health, Devices and Biosensors
With the rapid rise of mobile device usage in recent years, researchers are on the lookout for methods to utilize these devices for interacting more efficiently with their subjects. With a regulatory landscape that is still evolving, the tried and tested methods of in-person or phone conversations remain dominant methods of communication however there is an increase in utilization of capabilities such as automated reminders and alerts through phone, email and electronic messaging, which have demonstrated remarkable improvement in protocol compliance in many cases. We are also seeing an increase in the use of wearable technologies and other remote monitoring devices that help capture data directly from patients within the comfort of their day to day living space and routine. Such technologies can be extremely helpful in improving the patient’s experience in the study and helping retain them for the duration of the study.
It is clear that use of technology can promote transparency and make the research process more engaging and seamless for the patient. We are at an exciting time where we can allow our eagerness to bring multiple stakeholders together and our creative ability to develop powerful collaborative initiatives and platforms, lead us to usher in tremendous improvements into the entire research experience and empower patients by making them a more active participant in the process.