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Consult the e-patient experts before writing your clinical protocol

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In December 2016, Sally Crowe wrote an inspiring article in the British Medical Journal (BMJ) which called for clinical trial research companies, funders and journal publishers to be more proactive in incorporating patient perspectives into clinical research. As the BMJ article points out, “Incorporating patient perspectives more thoroughly into clinical research would also broaden its scope and help answer the research questions likely to bring about the biggest improvements in our understanding of disease.”

The article, which you can read here, offers real clarity on why ‘patient-centricity’ is such an important topic. Sally Crowe points out that patients often become experts in both their health conditions and related symptom management. Their knowledge is therefore a valuable resource for research professionals to draw on, but often it may be underestimated or overlooked. She also highlights that as the end users of the drugs being developed, patients and the public should have the chance to influence which conditions and treatments are the subject of new research.

Several pharmaceutical sponsor companies are piloting patient-centric initiatives by working with ‘e-patients’. These patients are well-informed and empowered by digital technology, and are often associated with patient advocacy groups. Many are actively involved in educating the public and specific-disease groups about the patient experience.

The increasing importance of e-patients

The emerging move towards a patient-centric drug development model has created the need for patient advocates who can effectively work as equal partners with drug developers and regulatory authorities throughout the drug R&D processes.

In response, non-profit organisations such as the European Patients’ Academy (EUPATI) are providing education and training to increase the capacity of e-patients to understand drug R&D, and become more actively involved during each stage of the process. This e-patient involvement starts from preclinical research and protocol development, all the way through clinical trial recruitment and publication of clinical study results.

A unique perspective

According to Jan Geissler (Director of EUPATI) in The CenterWatch Monthly, “Patients have a unique perspective on their needs and desires in terms of treatments, symptoms, side effects, quality of life and an adequate balance between the benefits and risks of treatment and research. Research and development might just end up with the wrong outcomes if patients and their unfiltered needs are not involved in research design.”

For example, PatientsLikeMe is a patient network and real-time research platform with over 500,000 members. It is described as "a trusted source for real-world disease information and a clinically robust resource that has published more than 80 research studies".

Ways to work with e-patients to make your trials more patient-centric

As Sally Crowe makes clear in her BMJ article, making clinical trials more patient-centric is becoming fundamental to successful drug development. According to Paul Wicks, Vice President of Innovation at PatientsLikeMe, there are some key ways that companies can work with e-patientsto ensure their trials are more patient-centric. These include involving patients from the start of the trial, including them on advisory boards and ensuring their feedback is always incorporated into trial design. You can read Paul’s advice in more detail here.

Involving e-patients at each of these pre-clinical research stages can help you to better allocate your resource money – allowing researchers to improve clinical trial protocol design, and address the most pressing needs of your patient populations.


There is a lot being said about running patient-centric clinical trials. Organisations such as PatientsLikeMe, as well as articles like Sally Crowe’s in the BMJ, help us focus on why and how to ensure patients really are at the centre of protocol development – because patient input has the potential to make our research processes better, and the outcomes more relevant to the patients receiving treatment at the other end.