Physician participation in clinical research and trials: issues and approaches

Abstract

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.

Managing clinical trials in Asia: Issues, threats, opportunities and approaches

“…5 However, there are several factors and problems responsible for the successful implementation of clinical trials in Asia which are related to managerial, ethical, clinical/scientific, regulatory reasons, as well as physicians/investigators and trial subjects. 7 Managing clinical trials requires efficient trial management strategies including standard trial management guidelines and robust methods of implementation and evaluation, the details of which are shown in Table 2. As markets are expanding in Asia, we have done a SWOT analysis (Table 3) to highlight the positive and negative issues for expanding clinical research markets.…”

“…Trial management is considered as the most crucial amongst the key competencies that are required to deliver high-quality trials. 7,8 According to the Medical Research Council (UK), the failure of some trials can directly related to trial management problems rather than scientific or trial 81 9 Clinical trials should be viewed from a 'business management perspective' and should include dimensions like 'marketing', 'sales' and 'ongoing client management'. 8 Regulatory bodies should develop and implement comprehensive regulations for clinical trials and establish monitoring framework to oversee the adherence to the GCP and local regulations.…”

“…1 Physician participation and patient recruitment are the major activities in trial management. 7 It has been highlighted that physician factors are related to the failure of adequate patient recruitment targets. Trials conducted in the UK showed that 45% failed to reach 80% of the target and it is more worrying that less than half of participating physicians succeeded in recruiting any patients.…”

“…12 Another concern is that the number of physicians pursuing a career in research has also declined. 7,13,14 Problems in patient recruitment to a trial may limit the statistical power of the trial to detect a treatment effect, 15,16 and the reduction in statistical power is considered one of the main reasons for abandoning trials early. 17,18 In addition, a less representative sample size also reduces the external validity of the trial.…”

“…15 To increase physician participation, the following issues should be adequately addressed: time constraints, doctor -patient relationships, concern for patients, reward and recognition, training, regular feedback and research interests. 7 Additional demands of the trial, patient preferences, concern caused by uncertainty and concerns about information and consent should also be taken into consideration to increase recruitment/participation of patients. 7 To be successful, most trials depend on developing some sort of collaborative group or network.…”