From initiation to marketing of the drug, compounds face numerous challenges to become an approved drug. Apart from preclinical, financial and approval stages, successful recruitment of patients for conducting clinical trials is one of the most challenging aspects. Factors like lack of patient education about clinical trials and complex study designs are considered as main reasons for delay in recruitment. Patient retention in the process of conducting trial affects conclusive results.
Trial participants may drop due to variety of reasons like lack of awareness, complexity of study protocol, or a fear of side effects. Retaining patients on protocols from start to finish can be just as challenging as recruiting enough people to start off.
According to a survey conducted on seventythree investigators from four zones, frequently encountered challenges in subject recruitment were complexity of study protocol (38 per cent), lack of awareness about clinical trials in patients (37 per cent ), and socio-cultural issues related to trial participation (37 per cent). Almost 50.7 per cent of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6 per cent) would enhance recruitment. Experiencing a serious adverse event, the subject's fear for study procedures (47 per cent) and side effects (44 per cent) were thought to have a moderate effect on subject retention.
Taking patients’ feedback on their experience in completing / discontinuing the trial may provide insight on how to improve the participants’ experience. Researchers at Nationwide Children's Hospital, US, noted that after the stakeholders' recommended changes were adopted into the study, the enrollment rate increased from 65 per cent to 95 per cent and the retention rate increased from 58 per cent to 85 per cent.
Relationship between site staff and the participants also enhances recruitment and retention. Recruiter communication behaviour could improve the probability of encouraging ambivalent patients into studies and lead to benefits for patients.
Apart from significant investment in infrastructure and perfect site management, special focus is required in development, testing and implementing processes to encourage recruitment and retention and make the trial successful. Successful clinical trials help change the future of medicine and improve millions of lives.
The cover story in this issue by Mary Pan, VP Asia Pacific, ICON plc., Japan, talks about how different regions are evolving to meet the challenges related to patient recruitment and retention in clinical trials. The article also highlights the impact of technological advancements on this scenario.