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      Fraud and misconduct in clinical research: A concern

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      Perspectives in Clinical Research
      Medknow Publications & Media Pvt Ltd
      Clinical research, fraud, misconduct

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          Abstract

          Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence.

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          Most cited references13

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          Repairing research integrity.

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            Quality of clinical trials: A moving target

            Arun Bhatt (2011)
            Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.
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              The effect of scientific misconduct on the results of clinical trials: a Delphi survey.

              To discover what types of scientific misconduct are most likely to influence the results of a clinical trial. Delphi survey of expert opinion with three rounds of consultation. Non-industry clinical trial "community". Experts identified from invitees to a previous MRC consultation on clinical trials. 32 out of the 40 experts approached agreed to participate. We identified thirteen forms of scientific misconduct for which there was majority agreement (>50%) that they would be likely or very likely to distort the results and majority agreement (>50%) that they would be likely or very likely to occur. Of these, the over-interpretation of 'significant' findings in small trials, selective reporting and inappropriate subgroup analyses were the main themes. According to this expert group, the most important forms of scientific misconduct in clinical trials are selective reporting and the opportunistic use of the play of chance. Data fabrication and falsification were not rated highly because it was considered that these were unlikely to occur. Registration and publication of detailed clinical trial protocols could make an important contribution to preventing scientific misconduct.
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                Author and article information

                Journal
                Perspect Clin Res
                Perspect Clin Res
                PCR
                Perspectives in Clinical Research
                Medknow Publications & Media Pvt Ltd (India )
                2229-3485
                2229-5488
                Apr-Jun 2013
                : 4
                : 2
                : 144-147
                Affiliations
                [1] Sr. CRA Group Head, Novartis Health Care Private Limited, Sandoz House, Worli, Mumbai, India
                Author notes
                Address for correspondence: Dr. Ashwaria Gupta, Sr. CRA Group Head, Novartis Health Care Private Limited, 5 th Floor, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai, India. E-mail: ashwaria.gupta@ 123456novartis.com
                Article
                PCR-4-144
                10.4103/2229-3485.111800
                3700330
                23833741
                6284aa9b-e40a-41ae-a32a-be72add940c0
                Copyright: © Perspectives in Clinical Research

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Quality

                Medicine
                clinical research,fraud,misconduct
                Medicine
                clinical research, fraud, misconduct

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