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May 4, 2016

Monitoring in investigator-initiated clinical trials

A research to barriers that impede adherence to national monitoring guidelines

In response to major incidences of fraud, data-manipulation and misconduct in both industry sponsored and investigator initiated clinical trials (e.g. the Polderman case) causing wildly publicized scandals, the Dutch governmental organization NFU (Nederlandse Federatie van Universitair Medische Centra / Dutch Federation of University Medical Centres) provided new monitoring guidelines in order to reduce fraud and misconduct and therewith increase quality within clinical trials at the end of 2011. However, following this guidance results in increased costs that are often unaffordable for multicentre investigator initiated studies therefore making the implementation of these guidelines uncertain.

I completed a research project on this conflicting topic in 2015. The aim was to investigate the feasibility of compliance with NFU’s monitoring guidelines by identifying the barriers, from the perspectives of multicentre investigator initiated studies that impede adherence to these NFU monitoring guidelines. Several theoretical models (i.e. adherence to practical guidelines and theory of planned behaviour) were used to obtain more information on these barriers: knowledge barriers (i.e. lack of awareness or lack of familiarity), attitudinal barriers (i.e. lack of agreement, outcome expectancy, motivation or inertia with previous practices), behavioural barriers (i.e. external barriers such as financial factors) and additional barriers (i.e. things that could not be thought of beforehand).

Fifteen (15) semi-structured interviews were conducted with a total of eighteen (18) respondents from all the eight (8) University Medical Centres in the Netherlands. These interviews included a quantitative survey of thirteen (13) questions, which was completed by twelve (12) respondents. The analysis of the interviews led to the conclusions that investigators in multicentre investigator initiated studies experience moderate knowledge barriers and behavioural barriers with regard to the compliance to monitoring guidelines.

To improve compliance with the monitoring guidelines, it is recommended to pay more attention to the actual act of monitoring thereby increasing familiarity with the guidelines. Moreover, it is important that the external barriers are lowered.

Recommendations are applicable to various actors: (i) subsidy providers might provide more information about how to budget for monitoring costs (ii) Clinical Research Bureaus (hospital organizations that strive to achieve optimal quality of clinical research within their hospital) could improve their assistance to the investigators especially more before ethical review submission (iii) and the hospital’s Board of Directors (BoD) could provide the Dutch “BROK-course” more often. This course is an obligatory course for Dutch investigators before they can start their research. Finally, an important barrier that was mentioned by the interviewees was that the 24 METCs and the BoDs of all the hospitals could increase their collaboration to unify regulatory standards and processes in order to make processes more uniform and therewith easier.

Recommendation: Investigators in the Netherlands experience barriers accessing the required know-how when it comes to monitoring in clinical trials. Similar barriers can be experienced by Investigators worldwide. Therefore, it is important to train them in depth on the requirements and familiarize them with the purpose of monitoring. A CRO can be a valuable resource when it comes to training of investigators on the various regulations and guidelines.

By Leonie van de Kamer



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