Physician participation in clinical research and trials: issues and approaches
Hospitals usually receive reimbursements for participating in clinical trials, either in cash, equipments, or additional staff. The clinician-researcher is able to make an important contribution to the quality of clinical services by facilitating an interactive flow of ideas between the clinical and research fields and disseminating evidence-based treatment approaches.
The economic opportunities created by clinical research draw more talented people into the medical profession in a country. The scope for clinical trials is increasing in developing countries 60 and opens the door for wider employment opportunities.
Physician participation in clinical research and trials: issues and approaches
Clinical research creates employment for site personnel, study monitors, and ancillary services, with an economic impact on the whole community. A study reported that medical students are largely unaware of the research activities in their host institution 59 and it is emphasized that adequate training should be provided on research methodology and biostatistics. Various authorities strongly emphasized the development of research-specific skills among undergraduate medical students along with other transferable skills.
In recent years, an increasing number of medical schools have implemented or are considering implementing structured research activities. This can be encouraged through formal training in student supervision and protection of faculty time for student project work. Medical schools should analyze current practices of teaching—learning and research while reflecting upon possible changes to develop a research culture using the model proposed by Healey and Jerkins 91 Figure 1.
The model suggested four main ways of engaging undergraduates with research and inquiry: Curriculum design and the research—teaching nexus. This model has two axes: All four ways of engaging students with research and inquiry are valid and valuable, and it is advocated that curricula should contain elements of all of them.
However, students should not spend nearly all their time in the top half, as tends to happen in some problem-based learning curricula. The organization should have adequate structure to support process and achieve outcomes.
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A well- planned implementation of these structures is likely to encourage clinicians to participate in clinical research. In addition, medical schools should develop effective institutional strategies and policies to highlight student awareness and experience of undergraduate research and inquiry using the following strategies:. The authors would like to thank the Open University Press for copyright permission to use Figure 1. National Center for Biotechnology Information , U. Adv Med Educ Pract.
Published online Mar 7. Author information Copyright and License information Disclaimer. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. This article has been cited by other articles in PMC. 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.
Introduction … the mind is not a vessel to be filled, but a fire to be kindled.
Plutarch, ca 46— AD In recent years, a paradigm shift has been noticed from experience-based to evidence-based practice in medicine and education. Barriers to participation in clinical research Many factors related to physician, patient, and trial characteristics may influence participation of physicians in clinical research. Table 1 Barriers to physician participation in clinical research and trials 4 , 7 , 8 , 17 , 19 — System-related and organization-related barriers Time involvement.
Open in a separate window. Strategies to encourage physician participation in clinical research In the absence of physician scientists, the bridge between bench and bedside will weaken, perhaps even collapse. Dr Leon Rosenberg To encourage physician participation in clinical research, organizational and operational infrastructures need to be strengthened by establishing effective relationships among structure, process, and outcome of research planning and management process.
Table 2 Operational and organizational structures needed to encourage physician participation in research. Resources Financial incentives have been shown to be among the most important factors motivating physician involvement in research. Policies and guidelines There is a need for developing appropriate policies for managing time for the physicians to minimize interference with clinical commitments and for payments and recognition for physician involvement in research.
Benefits of clinical research Clinical research provides benefits to physicians, patients, health care organizations, and the country as a whole. Benefits to physicians A clinician-researcher is considered to be an important figure in health research and emphasis has been given to involving more clinicians in patient-oriented research.
Benefits to patients Clinical research offers patients access to cutting-edge therapy, which could be lifesaving in addition to providing them with state-of-the-art quality care. Operational and financial benefits to health care organizations Research helps hospitals 58 and educational institutes 59 with additional funding for capacity building in core academic, clinical, and research activities.
Scientific benefits to health care organizations The clinician-researcher is able to make an important contribution to the quality of clinical services by facilitating an interactive flow of ideas between the clinical and research fields and disseminating evidence-based treatment approaches. Overall economic and strategic benefits The economic opportunities created by clinical research draw more talented people into the medical profession in a country. Research in medical curricula: In addition, medical schools should develop effective institutional strategies and policies to highlight student awareness and experience of undergraduate research and inquiry using the following strategies: Embed research in the mission and vision of the medical school.
Provide opportunities for all students to undertake undergraduate research and inquiry within and outside the curriculum. Acknowledgement The authors would like to thank the Open University Press for copyright permission to use Figure 1. Footnotes Disclosure The authors report no conflicts of interest in this work. American College of Cardiology Foundation.
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Clinical trials in cancer therapy: The impact of disease severity on the informed consent process in clinical research. N Engl J Med. Taylor KM, Kelner M. Interpreting physician participation in randomized clinical trials: J Health Soc Behav. Physician participation in a randomized clinical trial for ocular melanoma. Fundamental dilemmas of the randomized clinical trial process: Randomised clinical trials in general practice: Enrollment in clinical trials: Issues of recruitment, retention, and compliance in community-based clinical trials with traditionally underserved populations.
Nottingham University; Dec, Physician response to informed consent regulations for randomized clinical trials. Integrating conflicting professional roles: Doctor—patient communication about breast cancer adjuvant therapy. An evaluation of physician determinants in the referral of patients for cancer clinical trials in the community setting. Prog Clin Biol Res. Selection bias in clinical trials. The power of clinical nursing research: Am J Crit Care. Factors that limit the quality, number and progress of randomised controlled trials.
Investigator barriers and preferences to conduct clinical drug trials in Finland: Prevalence and determinants of physician participation in conducting pharmaceutical-sponsored clinical trials and lectures. J Gen Intern Med. Academic-industrial relationships in the life sciences. It covers all areas that a junior doctor needs to consider, including funding, study design, ethics, data analysis, disseminating findings, and furthering one's research career.
It presents a balance view of clinical research and is written by authors actively involved in clinical research both at the 'coal-face' and at a more supervisory level. Research can be a difficult process and it is essential to make sure that the project is set up in the correct way in order to get verifiable results. This easy-to-read guide is available to help junior doctors develop a good study design and present evidence of a sound academic practice, which will make obtaining funding more likely and be time-efficient. Getting started early in research and developing a solid, gradual understanding of clinical research through using this approachable book will be of huge benefit to junior doctors and their discipline.
The literature review 2. Types of research 3. Writing your research proposal 5. Data collection and research conduct issues 8. Writing up research Evidence based medicine Taking your research career further. He is a military surgeon in training with a strong interest in academia. He spent time after officer training researching the outcome of mild traumatic brain injury and has subsequently authored and co-authored papers in the fields of trauma and orthopaedics and military surgery.
William Eardley is an orthopaedic SpR.