The Clinician as Investigator

Lader, Ellis; Cannon, Christopher P.; Ohman, E. Magnus; Newby, L. Kristin; Sulmasy, Daniel P.; Barst, Robyn J.; Fair, Joan M.; Flather, Marcus; Freedman, Jane E.; Frye, Robert L.; Hand, Mary M.; Jesse, Robert L.; Werf, Frans Van de; Costa, Fernando Henrique da Silva

doi:10.1161/01.cir.0000128702.16441.75

Cited by 35 publications

(13 citation statements)

References 22 publications

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“…In addition, bioethics tends to privilege discussion about how ethics should be constituted in the clinic rather than what are the current practices and constraints placed upon investigators (Klein & Fleischman, 2002;Miller & Shorr, 2002). Moreover, there is little discussion about the extent to which private-sector physicians are represented in pharmaceutical research, the reasons why they become contract researchers, and how these reasons shape physicians' orientation toward research ethics (Lader et al, 2004).…”

Section: Background: Physicians As Investigatorsmentioning

confidence: 99%

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Fisher

2008

Social Science & Medicine

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This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

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Section: Background: Physicians As Investigatorsmentioning

confidence: 99%

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Fisher

2008

Social Science & Medicine

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“…In recent years, a paradigm shift has been noticed from experience-based to evidence-based practice in medicine and education 1–3. Research is the cornerstone of evidence-based medical practice, which translates new knowledge and technological capability into powerful tools for prevention and treatment of disease 4.…”

Section: Introductionmentioning

confidence: 99%

Physician participation in clinical research and trials: issues and approaches

Rahman¹,

Majumder²,

Shaban³

et al. 2011

AMEP

132

148

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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.

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“…Sharing of study product in clinical trials is considered to be a possible factor affecting adherence [16, 20, 21] and has been identified as a potential source of efficacy dilution in clinical trials [22]. If participants are using products that they have not been assigned, then differences between the treatment arms may not be detected [23]. Product sharing has also been recognized as a factor which could negatively affect the use of pill counts in a clinical trial [20].…”

Section: Introductionmentioning

confidence: 99%

Sharing of Investigational Drug Among Participants in the Voice Trial

et al. 2016

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Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting.

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The Clinician as Investigator

Cited by 35 publications

References 22 publications

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Physician participation in clinical research and trials: issues and approaches

Sharing of Investigational Drug Among Participants in the Voice Trial

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