Ethics in clinical research in India: A survey of clinical research professionals′ perceptions

Jadhav, Madhuri; Bhatt, Arun

doi:10.4103/2229-3485.106368

Cited by 16 publications

(13 citation statements)

References 4 publications

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“…Similar to our observations, a study by Jadhav and Bhatt reported that over half of the CT professionals from India believe that the risk of participation is inadequately explained to the trial subjects during the consent process. [ 17 ] On the other hand, in the study by Bindra and Kochhar 2010, almost a third of the doctors thought that some form of conflict of interest existed in being a CT investigator. [ 10 ] However, in spite of negative attitude regarding CTs in some specific items the overall mean perception score was found to be satisfactory (72.5% of maximum possible perception score).…”

Section: Discussionmentioning

confidence: 99%

Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study

Choudhury¹,

Pradhan²,

Dubey³

et al. 2016

Perspect Clin Res

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Aims:By virtue of being a specialized field by itself, the science of clinical trials (CTs) may not be well understood by doctors who are not specifically trained in it. A lack of knowledge may translate to a negative perception toward CT. With the idea of getting a situational snapshot, we estimated the knowledge and perception of CTs among doctors from government medical colleges of West Bengal who are not trained on CT in their postgraduate curriculum. Several determinants of knowledge and perception regarding CT were also evaluated.Methods:We have quantified the knowledge and perception of CTs by a structured validated questionnaire. Development and validation of the questionnaire was performed prior to the study.Results:Among 133 participants, 7.5% received focused training on CT and 16.5% participated in CTs as investigators. Majority of the doctors were unfamiliar with the basic terminologies such as, “adverse event” and “good clinical practice.” Encouragingly, 93.3% doctors advised that a detailed discussion of CT methodology should be incorporated in the under graduate medical science curriculum. They had an overall positive attitude toward CTs conducted in India, with a mean score that is 72.6% of the maximum positive score. However, a large number of the doctors were skeptical about the primary motivation and operations of pharmaceutical industry sponsored CTs, with 45% of them believing that patients are exploited in these sponsored CTs.Conclusion:Participant doctors had a basic knowledge of CT methodology. The study has revealed specific areas of deficient knowledge, which might be emphasized while designing focused training on CT methodology.

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Section: Discussionmentioning

confidence: 99%

Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study

Choudhury¹,

Pradhan²,

Dubey³

et al. 2016

Perspect Clin Res

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“…In a Questionnaire survey conducted by Jadhav M & Bhatt A, identified inadequacy of informed consent process and documentation as the major deficits among 500 clinical research professionals across India. 8 Soumil Patwardhan et al conducted a retrospective analysis of study protocols submitted to the Tata Memorial Hospital IEC and found no difference in the quality and adherence to GCP guidelines between Investigators -initiated trials and sponsored trials with exception of the Informed Consent process. 9 In a Qualitative analytical study of 162 academic research protocols submitted to our IEC undergraduate (n=60) and postgraduate (n=102) medical students, 91% of postgraduate medical protocols were approved in comparison to 72% undergraduate protocols.…”

Section: Discussionmentioning

confidence: 99%

Qualitative Analysis of Research Protocols Presented to the Institutional Ethics Committee in a Teaching Institution: A Re-Search on Research.

John

2015

J. Drug Delivery Ther.

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Research is an inborn trait present in all humans. Asking questions, searching for answers and expanding their knowledge databases have been crucial in the world of science. The field of Medicine is no exception to this trend as well. Primitive men gathered the knowledge of healing and medicine by observing nature and by personal experiences after consuming certain herbs and berries as remedies for their illnesses. However, these blind "trial and error"-based experimentation were termed obsolete and crude by the pioneers of Clinical Research.

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“…Potential strategies include: excluding high-risk patients, minimizing the number of patients on placebo, providing rescue medication, and maximizing safety assessments. 15,16 Respondents have suggested that study assessments (including PK sampling) should concentrate on minimizing discomfort, pain, and fear of invasive procedures. Additionally, younger children often have needle phobia, making obtaining the blood sample also a challenge.…”

Section: Ethical Considerationsmentioning

confidence: 99%

Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region

Saldanha¹,

Nayak²,

Sng³

et al. 2013

PHMT

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This site survey was conducted to understand the current pediatric clinical trial landscape across countries in the Asia Pacific region, specifically in terms of interest, experience, capabilities, requirements of the ethics committee, patient availability, and overall challenges involved in conducting pediatric trials. Methods and materials: Between May and June 2012, an English language survey form was sent to sites (identified through Quintiles' internal database) with pediatric capability and referrals from doctors during a preliminary outreach. In July 2012, the responses from the completed survey forms were entered into SurveyMethods, a web-based central repository. Data analysis was performed in August-September 2012 using SurveyMethods. Results: Seventy-seven sites were contacted for this survey across the Asia Pacific region. Sixty-four percent (49 sites) completed 63 surveys and confirmed interest to participate in clinical trials in the pediatric population. Seventy-one percent of the sites had prior experience. Eighty percent confirmed needing an assent from pediatric patients; 81%-95% confirmed acceptance of placebo-controlled and pharmacokinetic studies by ethics committees; and 37% cited challenges in conducting studies in this population. Conclusion: This survey indicates that there is a high level of interest among sites in the Asia Pacific region in conducting pediatric trials across various therapeutic indications. No major insurmountable challenges were identified in conducting pediatric trials. Complexity of the consent and assent process across the countries needs to be considered. Also to be considered are the sites' needs as well as trial design adaptations for this population to ensure compliance (minimize invasive procedures, placebo control, visit schedules versus school timings, etc). There also appears to be an adequate patient pool in many indications, and the availability of a database of healthy subjects can assist in faster screening of subjects for vaccine trials.

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Ethics in clinical research in India: A survey of clinical research professionals′ perceptions

Cited by 16 publications

References 4 publications

Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study

Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study

Qualitative Analysis of Research Protocols Presented to the Institutional Ethics Committee in a Teaching Institution: A Re-Search on Research.

Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region

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