Editorial

ike airline passengers, patients who choose to enroll in a clinical trial place their trust in the Principal Investigator (“the captain”), expect to be treated with respect and consideration for their needs by site staff (“cabin attendants”), hope to have a positive experience (“on-time flight to their destination”), and look forward to a certain measure of convenience (“seats, meals, cabin temperature, facilities”).

Unlike airline passengers, however, patients may not reach their desired destination (“the cure”), may be greatly inconvenienced (long and frequent trips to the clinical trial site for drug administrations, diagnostic procedures, and follow-up visits) and may have to disrupt their personal lives to participate in clinical research. Remote location of the clinical site is a significant deterrent to participation in a trial, particularly for patients in rural areas.

As a result, many patients who could take part in clinical trials choose to not do so, citing personal inconvenience and conflicting personal, professional, and family priorities. Since industry’s ability to conduct clinical trials depends on patients’ willingness to participate in their conduct, reluctance to do so can have a chilling effect on the development of new medicines.

This may soon change. The growing global interest in virtual trials, remote trials, siteless trials, location-flexible trials, decentralized trials, and direct-to-patient trials is driven by a dynamic movement to make clinical research significantly more convenient for patients. The idea is to take aspects of clinical trials to the patient’s home (for instance, delivery of study drug, administration of study drug, routine monitoring of vital signs and study endpoints, sample collection, medical visits by telemedicine, data collection via wearable devices, and return of supplies by shipment from the patient’s home) rather than compelling the patient to travel to the clinical site which may be some significant distance away and may force the participant to miss work or to find alternative child care. Sponsors, CROs, and investigators are exploring new avenues to improve the experience of patients in clinical trials. This goal will require close collaboration among numerous stakeholders.

This trend was very much in evidence at the DIA Japan Annual Meeting 2019 in mid-November, mirroring similar discussions in Europe, China, and the US. The patient’s voice is being heard in this context as well as in the design of protocols, the choice of endpoints, in definition of unmet medical needs and pertinent patient-reported outcomes, and in regulatory and payer decisions. Regulators are expected to support this trend so long as virtual trials are GCP-compliant and data reliability is protected.

It is well documented that many patients participate in clinical trials not only to help themselves but also to help others by supporting the advancement of science and medicine. It is incumbent on the clinical research community to meet these patients “more than half way” and to facilitate their participation by increasing the convenience and simplifying the logistics of clinical trials.

Of course, many operational details remain to worked out and virtual trials will not be suitable for every disease. But a significant global effort is now underway to explore what is possible and practical. If we succeed in this effort, clinical trials may turn out to be far better enrolled and more enjoyable and beneficial for all concerned—especially for patients.

Have a safe and pleasant trial.