Data handling in clinical trials: an ongoing debate.
Data handling is a crucial phase in controlled clinical trials. In this paper we conceive the process of data handling in a broad sense, encompassing monitoring, analysis and publication of data. We discuss basic ethical principles underlying adequate data handling and suggest some modifications of the Good Clinical Practice guidelines. As to data monitoring, we underline the corporate responsibilities and argue in favour of an independent Data and Safety Monitoring Board (DSMB). Data analysis should be performed in independent institutions, and there is a moral obligation to perform an interim analysis. Regarding accessibility of data, the raw data should be made available to participating researchers and independent scientific institutions, and both positive and negative results should be published, in agreement with a Report on Drug Information by the World Health Organization. To meet these requirements, commercial sponsors should have initiatives for independent DSMBs, interim analysis and complete data availability, and conceive corresponding contracts. The investigators can improve the quality of data handling by forming an Investigators Liaison Panel that represents them in the contacts with the sponsor. Finally, ethics committee and drug regulatory agencies should see to it that newly gained insights are being put into practice.
Jongen
P J
PJ
European Charcot Foundation, Institute for Neurology, University Hospital Nijmegen, The Netherlands.
D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003627:Data Interpretation, Statistical; D006801:Humans