Physician participation in clinical research and trials: issues and approaches

Figures & data

Table 1 Barriers to physician participation in clinical research and trials^{4,7,8,17,19–23}

System-related and organization-related barriers Time involvement ○ Extra research-related work ○ Discussions with patients ○ Grant applications and ethics submissions Resource issues ○ Costs involved in research participation ○ Facilities and infrastructure ■ Inadequate administrative support ■ Clerical activities/paperwork ■ Inadequate provision of data management facilities ■ Lack of staff and training ■ Bureaucracy ○ Requirements of funders and sponsors ○ Culture of health care organizations: prioritizing clinical work over research ○ Consent interviews ○ Identifying patients (insufficient number available, competition from other trials, restricted eligibility criteria) Trial design-related barriers Lack of clinical and scientific rationale of research ○ Inappropriate study question ○ Less visible potential to improve patient care ○ Inappropriate standard therapy arm ○ Minimal impact on clinical practice Increasing complexity of trials Excessive trial costs not covered by the trial sponsor Inferior trial medications compared to standard therapy Difficulty in obtaining funding Complex grant process Problem in obtaining informed consent Gatekeeping on behalf of the patients Not interested in participating in sponsored clinical research Difficulty in accessing the appropriate patient population Problems specific to recruitment of ethnic minority patients Physician-related barriers Field, setting, and academic profile of physicians Lack of interest of physicians in the research topic Limited familiarity with research methods and procedures Disruption to clinical practice Loss of professional autonomy ○ Role conflict of clinician and scientist Uncertainty inherent in clinical research Potential side effects Lack of awareness of ongoing trials Negative effect on doctor–patient relationship Gatekeeping because of bias for/against treatment arm Gatekeeping on behalf of the patients Lack of degree of recognition Inadequate financial compensation

Table 2 Operational and organizational structures needed to encourage physician participation in research

Structure	Process	Outcome
Resources	Policy and procedures	Influence care for patients and their families
Human	Publications of guidelines	Improve patients’ lives
Financial	Time management	Encourage professional growth and development
Research environment and infrastructures	Reimbursement	Recruit and retain jobs
Structures and forums	Reward and recognition	Generate more resources and funds for medical schools and health care organizations
Research committee	Involvement in research committee
Network	Create internal expertise of clinical leadership
Academic–industry–national hospital service relationships	Establish research groups
	Collaborate with other organizations
Training and teaching	Promote evidence-driven practice
Fellowship	Rapid learning health care system
Mentored program	Research in undergraduate medical curricula
Seminar/workshop
Research bursaries

Figure 1 Curriculum design and the research–teaching nexus.⁹¹

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