Journal of Clinical Trials
Open Access

Fraud and misconduct of clinical trials

International Conference on Clinical Trials

July 27-29, 2015 Orlando-FL, USA

Rucha Majmundar Mehta

ScientificTracks Abstracts-Workshop: J Clin Trials

Abstract :

Fraud and misconduct in the research community occur more often than we would wish to believe. While it is impossible to
provide a definitive figure for the frequency of its occurrence surveys provide us with consistently (and perhaps surprisingly)
high estimates. Fraudulent clinical research affects the validity of data and impacts on the dignity, rights, well-being and safety of
research participants. There are a variety of definitions of fraud and scientific misconduct. Often, the terms ‘fraud’ and ‘misconduct’
are used interchangeably. Generally, fraud describes acts of omission and commission, consciously not revealing all data and
consciously altering or fabricating data. Such falsification of data can occur at any stage of the research process, from initial design
through to reporting results. Fraud does not include honest errors or differences in opinion and the usual definitions include an
element of intent. Repeated non-compliance with the study protocol and GCP may be considered as an example of misconduct,
although the end result may well be similar to deliberate fraud. There are examples, from the beginning of a clinical trial to
submission of a final manuscript, of dishonesty and deceit in general practice and primary care research. Patients have been
invented to increase numbers (and profits) in clinical trials, ethical guidance on consent and confidentiality have been breached,
and duplicate publication crop up from time to time. It is important for us all to be aware of the legal and ethical frameworks within
which research is undertaken and of the steps that are available to prevent fraudulent and dishonest research being undertaken
and written up.

Biography :

Rucha Majmundar Mehta is an Independent GCP auditor (Free Lancer) since 8 years. She developed a Clinical Research Site in a privately owned small sized
hospital and heading the site till date. She is providing QA consultation and training to various study sites and QA department of Pharmaceutical Companies. She
conducts GCP Sessions during Investigators Meetings globally. She has participated in State, National and International Conferences of Clinical Research as a
faculty. She is conducting GCP workshops for Clinical Research Professionals for on-going basis and during conferences. She is active member of EFGCP–AWP
and RQA.