Patient recruitment and retention in clinical research remains a big challenge, despite a heavy spending on these efforts. As per a recent write-up in pharmaceutical-technology.com, as many as one in five trials (15-20%) are unable to enrol a single patient, and thus never begin. Other data suggest the 'failure to start' rate is even higher, thus either leading to site closure or replacement within 3-4 months of the trial initiation. In today’s competitive environment where small and big pharmaceutical companies are competing with each other to capture the market position, early enrolment plays a crucial role in meeting the enrolment deadlines and thus accelerating regulatory filing and product approvals.
For clinical trials that at least begin and start enrolling patients, the patient retention becomes a major concern as it is estimated that out of 100 patients enrolled in the study only 75 patients complete the study, leading to an average attrition rate of 25%.
Considering the above facts, it is important that a concoction of effective recruitment and retention strategies are implemented and maintained in clinical trials to achieve desired outcome. The recruitment and retention programmes should start with a customized, data-driven and patient-centric strategy, as every protocol presents distinctive challenges for patient recruitment and retention. Without a proactive approach for patient recruitment and retention, many companies and their prized products fail and huge amount of valuable time and millions of dollars are lost.
Excel Life Sciences (ELS) has pioneered the skills of preparing an effective patient recruitment and retention strategies. Since inception of ELS in 2005, we have been successful in maintaining our reputation as a global recruitment and retention leader. Where the industry estimates an average patient attrition rate of 25 per cent in clinical trials, we have been successful in maintain our average patient attrition rate at less than 5 per cent (Figure 1) for major therapeutic areas like endocrinology, neurology, ophthalmology, infectious disease, and oncology etc.
Our success in the commendable patient recruitment and retention is attributed to:
1. Highly effective feasibility process leading to selection of the state-of-the-art sites and highly experienced investigators with large patient pool.
2. The painstaking efforts of our Clinical Research Coordinators who work closely with patients and investigators, and actively follow up with patients to ensure 100% retention. They help in creating a symbiotic environment where the patients receive benefits of high standard medical care and support services and investigators get benefited by recruitment and retention of patients within a specified timeline.
3. Thoughtful, proactive and project specific approach of creating pre-emptive and effective strategies for patient recruitment and retention.
4. Effective implementation of strategies via periodic trainings, regular evaluation and analysis and implementation of proper corrective actions as needed.
5. Effective use of technology for better patient compliance and retention.
(The author is asst. manager, regulatory affairs, Excel Life Sciences Pvt. Ltd.)