The clinical research industry thrives on efficient patient recruitment and retention. One of the most challenging aspects in a randomised controlled trial is reaching the set target patient population. Poor recruitment figures questions the financial and scientific viability of a clinical trial. If the estimated sample size of a clinical trial is not met, then there is the possibility of erroneously concluding the trial with no significant difference between the treatment groups. Adequate enrolment in clinical trials, give a chance for achieving the projected retention target and helps in the evaluation of subject data without having to extend the timeframe of a clinical trial. Such delays puts any clinical trial in uncertainty accounting to a staggering cost .

3H is Japan’s largest patient recruitment company holding a clinical trial patient database of over 820,000 nationwide.

3H Medi Solution considers recruitment of trial subjects as a crucial step for the success of any clinical trial. Currently, 3H is Japan’s largest patient recruitment company holding a clinical trial patient database of over 820,000 nationwide. The database covers patients of over 300 diseases and symptoms. 3H has thus moved to the next level, utilizing the latest technology to connect with potential clinical trial subjects while empowering them to decide the clinical trials they want to participate in.

Let us see some of the common recruitment challenges faced in clinical trials and how 3H has successfully fixed these issues.

What Fails Clinical Trial Recruitment? The last decade has witnessed an unprecedented advancement in clinical trial conduct with new drugs being developed for orphan diseases as well. However, the concept of clinical trials is still perceived with doubt, suspicion and distrust among the Asian public. This is mainly due to participants not being able to choose their treatment in randomised trials and also the fear of being treated as ‘guinea pigs’. In recent times, the media too has highlighted clinical trials in a negative light, fanning flames in the public. A recent survey conducted in India, showed that 37% of the population, lacked awareness about clinical trials, and 63% of clinical site investigators strongly felt that creating positive awareness about clinical trials in the public through press and media could enhance recruitment (Kadam et al, 2016).

3H Medi Solution has been working across the Asian continent to connect people’s health and happiness, supporting communication among stakeholders and disseminating information about clinical trials, trying to bring in more awareness about clinical trials among the general public. Leveraging the present technology, 3H has reached the public through social media and other offline media outreach. The website Seikatsu-Kojo is an educative platform which enhances clinical trial and disease awareness, while giving a chance for potential subjects to register.

Complexity of Study Protocols: The increase in protocol complexity can greatly hamper clinical trial recruitment and drive up the cost for developing new drugs as concluded by a recent study by Tufts Centre. Associate Professor, Dr. Ken Getz has cited after the analysis of 9737 protocols across 178 global pharmaceutical companies, that complex protocol design and scope, for difficult to treat and rare diseases could accelerate recruitment challenges which has the need to enrol stratified patient populations, to attain a higher and diverse data volume. Complex protocols are also seen to burden trial sites with additional internal and external staff to execute more procedures.

3H Medi solution understands the importance of patient-centric study protocols. Thus, the company has invested in collecting feedback from patients and caregivers for developing and designing of study protocols. This facilitates flexible schedules for patients and helps in discarding unwanted procedures, which could otherwise put subjects under strain. Patient-centric study protocols improves subject retention and brings down the cost of conducting clinical trials. 3H’s Clinical Trial Application, P-Guardian is a great engagement tool which collects feedback and wellbeing of trial subjects. This input by subjects is invaluable for developing patient-centric study protocols.

Gearing up the clinical trial study sites: Having a strong team in a clinical trial site is essential for optimal recruitment. The lead initiative must be taken by the principal investigator who drives the success of any clinical trial. Thus, pharma companies should have the prime goal of handpicking well qualified and enthusiastic investigators who would conduct clinical trials with utmost responsibility. It is the principal investigators who form the link between the trial subjects and the pharma sponsors. The study sites should be equipped with the right people and infrastructure for the smooth conduct of clinical trials. Kadam et al, (2016) has shown that having a dedicated clinical research coordinator increases recruitment by 50.7%. In addition a competent team with a recruitment strategy. further enhanced recruitment by 46.6%. Special attention through continuous trainings should be given to under-performing sites to boost recruitment. In addition, a good referral system is essential to increase the likelihood of recruitment. A friendly setting, which understands the needs of the trial subjects is sure to boost recruitment. Thus, facilitating transport for less mobile patients and conducting home visits can improve both recruitment and retention.

3H has always been a pioneer in facilitating innovative solutions for clinical trial recruitment. As Japan’s first consulting CRO which specialises in patient recruitment, the company provides unique recruitment strategies with successful site selection, while having qualified principal investigators. 3H conducts feasibility of study sites using IT tools like PASSMAP. A strong database which has the REGUSYS system, prevents dual entry of patients into clinical trials. A good example is the Phase III study conducted for an overactive bladder, where 95% of study sites were selected within 10 minutes of walking distance for the subjects. The recruitment strategy adopted was having a contact centre to coordinate the initial screening of patients. Selected patients were redirected to the closest sites from their homes.

3H further assists study sites with easy recruitment tools like posters and videos to spread awareness about the trial and newsletters for physicians to keep them updated on the status of the trial. Motivating tools and materials like ipads are given to CRCs to assist them in their work. In-Home clinical trial services by physicians and virtual clinical trial conduct solves recruitment worries. Recently 3H successfully completed a virtual study in Oncology for the monitoring of adverse events by using the P-Guardian system, while assessing the quality of life of patients electronically.

Overcoming recruitment challenges and Future of Recruitment in Clinical Trials: There are many bottlenecks for clinical trial recruitment. Recruitment efficiency can be improved through

·     A dedicated study team for each trial

·     Designing recruitment strategies before the study initiation

·     Building public awareness about clinical trial conduct

·     Patient engagement and putting their feedback into use in protocol designing

·     Spreading positive views on clinical trial conduct in press and media

·     Facilitating subject visits through transport or in-home visits.

With technology uniting with clinical trials, the gap in recruitment figures is narrowing. Doctors are the gateway to patients; modern smart wearable devices and e-platforms have given easy accessibility for patients and physicians to communicate and engage about health issues. Virtual screening of patients through online patient registries and data bases helps reach out to a large population. Social media and internet penetration too have empowered patients on disease conditions giving them a chance to selecting the trials they want to be a part of.

Thus, the future of clinical trials is fast moving into a virtual setting……………