The environment for clinical research is tougher than ever. According to one study, the median cost per patient now stands at $41,117¹. As the cost per patient continues to increase, finding ways to improve patient retention and compliance becomes critical. It is against this backdrop that study teams are recognizing the value of patient engagement in clinical trials.
What is Patient Engagement?
Patient engagement is the holistic approach of treating patients as collaborators in the process of conducting research. Patient engagement leverages their insights to inform study design with the goal of obtaining meaningful, high-quality data. Most importantly, patient engagement provides study participants with transparent information about their role and offers them tools to stay informed and compliant with the study protocol.
How Do We Create Patient Engagement?
Patient engagement starts with the very basic design elements of a clinical trial. When possible, study teams should reach out to patient advocacy groups to help understand the unique needs of their community. What are some of the challenges patients may face in participating in this study? How can we better accommodate and address these issues to create an environment where participation is easy?
This may include things like –
- Offering transportation or flexible scheduling options
- Communicating the value of research in a clear and understandable way
- Providing tools that make completing study tasks easy
- Developing a study roadmap to keep patients informed
Site location and disruption of daily routine are two of the most common reasons patients cite for not being able to participate in clinical studies². If a patient works, has children, or both, finding time to come into the clinic can be challenging. Offering weekend appointments, providing transportation or offering remote telehealth visits (when appropriate) are all opportunities for study teams to improve patient engagement.
Crafting a message around the study can also help, particularly during the recruitment phase of the study. Be clear about the study’s goals and how this research can play a positive role in the lives of those living with the disease. While this may seem obvious for oncology research it may be less so for other diseases. Share information such as the number of people impacted by the disease and what current treatment options lack.
In addition to addressing logistical concerns and communicating value, providing tools and information to patients is critical in the execution of any patient engagement strategy. Once a study is underway, the various study tasks and instruments will need to be interwoven into the patient’s normal life. Providing tools to make participation easier can have a huge impact on a patient’s capacity to stay engaged with the study over a long period of time³.
For studies utilizing outcomes, diaries, journals or other patient-generated data, the use of a mobile app to capture information may be an easy way to foster engagement during the course of the trial. Apps allow patients to easily see what they need to complete and enables them to enter data wherever they are. This not only improves engagement but can reduce the risk of recall bias.
Offering a study roadmap is another patient engagement strategy to consider. Give patients reference materials that make it easy to understand what tasks and activities they will need to complete. How often will they need to complete their patient diary? When is their next visit? How long is the study? What happens after that? These are all questions patients will have and providing documentation, either digitally through an app or on paper, can make the experience much easier.
The Bottom Line
Patient engagement is the process of reducing barriers, enhancing patient knowledge and making study participation easy. With R&D expenses now at $2.7 billion per approval, the need to weave patient engagement into study design is critical to the advancement of new medications.
¹”Estimated Costs of Pivotal Trials for Novel Therapeutic Agents ….” 24 Sep. 2018, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2702287. Accessed 9 Jan. 2020.
² “Global Public Attitudes About Clinical ….” 5 Oct. 2018, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2705849. Accessed 9 Jan. 2020.
³”D3 Conference poster_rd3 – Datacubed Health.” https://www.datacubed.com/wp-content/uploads/2019/10/ISPOR_Poster_Datacubed_Health.pdf. Accessed 9 Jan. 2020.