Qualitative features in clinical trials: coordinates for prevention of passive and active misconduct


  • José Roberto Wajman Federal University of São Paulo, Sector of Behavioral Neurology. Department of Neurology and Neurosurgery (UNIFESP), São Paulo http://orcid.org/0000-0002-9296-2498
  • Sheilla de Medeiros Correia Marin Federal University of São Paulo, Sector of Behavioral Neurology. Department of Neurology and Neurosurgery (UNIFESP), São Paulo
  • Paulo Henrique Ferreira Bertolucci Federal University of São Paulo, Sector of Behavioral Neurology. Department of Neurology and Neurosurgery (UNIFESP), São Paulo
  • Marcia Lorena Fagundes Chaves Department of Internal Medicine, Faculty of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre
  • Theresa Bromley Global Rater Training Services at ePharmaSolutions (ePS), Philadelphia, PA Clinical Services, MedAvante-ProPhase, New York, NY




Good clinical practice, Clinical trial, Data quality, Research misconduct, Fraud prevention


For many years, the quality concept in clinical trials has been discussed and recommended by Good Clinical Practice (GCP) guidelines. Regulatory Authorities and also the Public Involvement anticipate that the pharmaceutical industry will concentrate on creating quality frameworks amid the arranging and leading of conventions of controlled protocols. Nevertheless, many factors have been suggested as contributing to the occurrence of scientific misconduct within the research field, such as: personal and financial interests, site monitoring, available resources, workload, competition among investigators, and the implicit consent of sponsors. The negligence on data fraud represents not only omission but misconduct as well, in this case, a passive attitude intrinsically related to the act of transgression. A properly culture of research must be based on a fundamental ethos of integrity, openness and honest work of high quality in all parts of the research process. There is a need to change the focus from inspection-based quality improvement to planned systematic quality management within clinical trials. In search for a monitoring improvement, a full statistical  way to deal with information recognition comprises of executing however many measurable tests as could be allowed on whatever number clinical information factors as could be expected under varied circumstances. Adoption of specific and preventive clinical trial monitoring procedures can identify potential misconduct and data fraud leading to improvement in overall data quality and scientific reports. 

Author Biography

José Roberto Wajman, Federal University of São Paulo, Sector of Behavioral Neurology. Department of Neurology and Neurosurgery (UNIFESP), São Paulo

Behavioral Neurology Sector. Department of Neurology and Neurosurgery. Affiliate professor.


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