It is widely known and understood that the no. 1 cause of delays in clinical trials is inefficient patient enrolment. The problem has become widespread and does not show any signs of abating. According to a TUFTS analysis, 48% of investigative sites either under-enroll or fail to enroll subjects. This leads to prolongation of study timelines, delayed marketing authorizations for important drugs and very significant financial losses for pharmaceutical and biopharmaceutical companies.
To rectify the patient enrollment gap, much time and effort is spent on advertisement for participation in clinical trials. The use of traditional and social media in direct-to-patient advertising of clinical trials is well established and popular in areas such as the United States, but the problems regarding delays in enrollment are not ceasing. This clearly indicates that new strategies should be sought out and implemented.
Many sponsors and CROs have tried to increase patient enrolment rates by engaging external physicians. EC/IRB-approved principal investigator (PI) letters to colleagues and other physicians is a well-known example of such attempts. However, in reality, PIs typically lack both time and motivation to fully engage in building and managing a referral network. Even when external physicians respond to a PI’s letter and try to refer patients, without proper organization and support, many of these patients simply never reach the investigative sites.
Some useful data illustrating the current state of engagement of referring healthcare professionals comes from a 2017 Tufts CSDD survey of 2,000 nurses and physicians. It was revealed that 70% and 90% of them are comfortable with discussing clinical trials with their patients but less than 0.2% actually do so. The main reasons for this, according to the Tufts impact report, are that: Physicians and nurses have limited information about the relevant clinical trials, they do not have enough time, and poor communication and co-ordination between the parties involved in the referral process makes it inefficient.
This firmly suggests that supportive strategies should be developed, which will create a system of support for external physicians’ referrals and improve communication between referring physicians, sponsors and CROs, and study investigators.
A new, innovative strategy which targets these problems, is ePatientFinder’s Clinical Trial Exchange™ platform. On the platform, patients’ electronic health records (EHR) and information regarding ongoing trials (filtered by geography and specialty) are matched and brought to the attention of physicians who have suitable patient resources. The patients identified through the system, are invited by physicians for a discussion and personal pre-evaluation which makes sure that the patients who are eventually referred are highly qualified and willing to participate in clinical studies.
We here at Clinical Accelerator and ClinAccel.Net have always valued the role of external physicians in effective patient enrolment campaigns. Having worked in the patient enrolment support field for many years, we have developed an enhanced patient enrolment model involving a large, ever-growing network of referring physicians working in all major therapeutic areas and our PEMs (patient enrolment managers) who identify relevant external physicians, help them with patient identification and manage the whole referral process. They ensure streamlined and effective communication between the referring physicians and study investigators and take care of simple but important tasks such as patients’ transportation to clinical sites and remuneration for their spent time.
Rather than focusing on direct-to-patient advertising campaigns, our focus is on patient information campaigns delivered by our partner physicians who care medically for the patients we seek for enrolment into clinical trials. Our PEMs assist doctors in designing and delivering these patient-oriented campaigns and providing them with IRB-approved supporting materials which are typically used within healthcare institution environments.
The end result of taking full advantage of referring physicians’ untapped potential, is that qualified patients are identified, screened and referred in high numbers and at speed, leading to faster patient recruitment, more compact study timelines and reduced trial costs.
Poor physician and nurse engagement driving low patient recruitment. Tufts Center for the Study of Drug Development Impact Report. Jan/Feb, 2017, Vol. 19 No. 1.