Patient co-creation through a patient community equals more successful clinical study experiences for participants and researchers alike.
Patient Co-creation is key
Time after time we see that a patient co-creative approach to clinical trials has many advantages. This is especially the case in terms of increased study retention and compliance, and involving patients also leads to better study execution. It has more or less become a common belief within the clinical study environment that co-creating all aspects of a clinical study with patients improves the overall success of clinical studies.
The conduct of patient engaging clinical studies continuously improves -especially with the possibilities granted by the advancement of technology. Decentralized clinical studies are a modification of traditional clinical studies where study data is collected remotely. The remote monitoring empowers the study participants to decide when to attend to their study tasks – whether they are at home, at work or travelling. For the participants this equals a more comfortable setting. For the pharma industry, it equals collection of real world data to a higher degree than in a traditional clinical study environment. In addition, the remote, digital design makes studies more cost-effective and time-saving.
Co-creation with patients will optimize remote clinical studies
The boom of digital technologies, such as smartphones, is already making recruitment, data provision, study visits, and well, participation in general more convenient for patients. However, at the same time the digital study approach changes the role of patients, requiring them to contribute more actively than what is the case in traditional site-based trials. We know that the accommodation of this shift requires a change from a site- and regulator-centric approach to a patient co-creative approach.
Decentralized clinical studies in a fully or partly remote format affects three major aspects that must be considered to design a successful user experience within the study:
Tasks: Study participants perform tasks and report data directly through a study app on their smartphones to the study staff. The success of designing a user centric solution that participants will like requires a thorough understanding of patients’ motivations and barriers, the level of engagement, capacity and capability of prospective participants, – as well as clear and easy to understand information.
Setting: Participants perform tasks and provide data when they are at home. Settings (locations) affect human thinking and behaviour and therefore we need to plan with an everyday setting – and not the clinic – in mind.
Communication: The communication form in digital clinical studies varies to a large extent from the traditional study setting. Participants and study staff primarily communicate via smartphones, email and text messages, either planned or when participants reach out for support. This requires a much more conversational style than the written information in the Informed Consent Form and any other patient facing material. Every piece of text or visual on a smartphone needs to be developed in plain language based on UI/UX principles which differ from complex scientific or regulatory information. Digital clinical studies are definitely a step in the right direction towards patient co-creation. However, digital clinical studies and patient co-creation do not equal each other by default. To meet the above criteria in the planning and design of a study, patient engagement is essential. We need to move much closer to patients’ real life settings if we are to succeed. Meeting the needs of the study participants in a remote setting will require new ways of planning, researching, and collaborating, but the advantages and end-results clearly outweigh the extra efforts from both the study team and the patients who contribute.
Patient Engagement in the DCT planning and design
It is important to acknowledge that different patients bring insights that contribute to solutions at different strategic levels, and that we need insights from both patients with and without prior knowledge about clinical trials in order to achieve our goals.
We consider patient contributions to clinical studies at three levels:
- Individual patients who provide insights about their lived experience. They bring value to our understanding of the population, their pain points, motivations, and everyday situations and will help us design relevant tasks and procedures. They also provide inspiration for which terms and wording are used and accepted by the patient population and which we should integrate in our general communication.
- Patients representatives from organizations or networks who have broad insights across a given patient group. They help ensure that we do not overlook important aspects that may not be raised by individual patients. They also may serve to confirm and weigh the insights provided by individual patients.
- Patients who have in depth knowledge about clinical trials (patient experts) and are able to bridge the patient perspectives and study objectives. They bring value at decision points and help ensure that the study design and participant tasks meet both participant and research needs. Patient experts may also help finding solutions for cultural or sensitive aspects within the scientific and regulatory frames.
Patient communities enable better research
So how do we make sure that patients on all three levels get a chance to contribute at the right time and in the right phases of a study?
Early patient co-creation could be the key. One method of ensuring patient access and collaboration in the earliest phases of study development is to create a patient community that includes patients who have an interest in research regardless of diseases or previous experience with clinical research.
The purpose of such a patient community is to involve patients, elevate their voices and learn from the people we want to help in order to provide strong trial data to the sponsors, while simultaneously delivering an enjoyable study experience to the participants.
Having access to patients via a community – patients who are truly engaged in improving lives and treatments for others living with the same disease as themselves is a win-win for both patients and researchers.
In this way the ‘Nothing about you without you’-approach has proven to be the most valuable guiding principle.
