During the current public health challenge we are being asked to do a range of things differently as we engage with health services and interact with the stuff of daily living. This includes where and how we access services, interact with healthcare professionals, and how we manage person to person contact; it extends to how we maintain vigilance and report symptoms. All in a common endeavour of making sure that the current COVID-19 pandemic is monitored, understood and controlled for the benefit of all.
The principles of monitoring, understanding and thereby developing disease control, modification or cure are common to the process of clinical trials. Just as people now are being asked to engage, in clinical trials the same ask is made. However, engaging people as the raw materials of a clinical trial study requires more than setting out the ‘what’, ‘who’, ‘why’, ‘how’, ‘when’ and detailing the projected benefits. These might be the factors necessary to comply with current protocols and give the patients the safety confidence to get involved, but people need to feel that they are more than just an input to the process.
The healthcare landscape and the pharma space are rich in patient experience, and that experience is of a value greater than just forming the basis of a sample group. Patients need to be the co-designers of clinical trials. Their collective experience will have much to offer in terms of discovery; widening the efficacy of treatment beyond the ‘body-part’ dynamics into how it registers on well-being and restores a normalised lifestyle.
Any organisation interested in clinical research and its methodologies should start with the right outlook. Deciding on the desired outcome then committing to a process of reverse design, that ticks off all the regulatory and clinical demands until it arrives at the patient experience and then overlays that across the process, isn’t patient-centric. Being patient-centric means using the patient experience to drive research and development and shape the culture of discovery. Patients brought into an enterprise as architects, designers and equal partners will stay with the process.
Involving patients as partners is a must, so is engaging them on how they contribute. Digital methodologies are powerful tools in securing engagement and adherence. If you look at examples of patient engagement elsewhere in healthcare, you will see many NHS commissioners and providers struggling to meet their statutory obligation to engage patients in service design, development and change. Those that follow the conventional model of patient participation, requiring patients to gather in a certain room at a certain time for a certain agenda, will not have as positive level of participation as those that use digital and informal opportunities. The latter is a good example for clinical trials.
Having access to patients where they are and via the channels they use to access their healthcare is key to both recruiting and sustaining involvement. Many medicines and treatments offer a patient app and this technology can be adapted to gather and manage the data required for clinical trials. Many patients will attend outpatient clinics and community pharmacies and face to face contact in these places will help secure participation.
With the advent of the NHS Commercial Medicines Directorate and the Accelerated Access Collaborative, and the new dialogue between the NHS and pharma moving it from its traditional place of supplier to partner, the future of clinical research can benefit from a more collaborative approach. The most important collaboration is with patients; that’s the future.
Johnny Skillicorn-Aston is engagement and communication director and James Roach managing director of Conclusio. For more information visit www.conclusio.org.uk or email enquiries@conclusio.org.uk
