EFGCP Puts Renewed Emphasis on Complex Studies


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-04-01-2017
Volume 26
Issue 4

The European Forum for Good Clinical Practice to examine the impact of current regulations and areas such as big data and quality management on so-called complex studies.

The European Forum for Good Clinical Practice (EFGCP) has unveiled plans to boost quality and innovation in so-called complex studies, which it defines as being more difficult to develop and design, to recruit for, and to evaluate once the clinical trial has been completed.

“The subjects are from populations that are typically vulnerable because of the potentially complex interventions required, the lack of treatment options, the use of more novel compounds, the difficult choice of comparators/use of placebo, or it could be that the outcomes are more difficult to measure,” notes a statement issued by the EFGCP. “These types of studies include rare diseases/orphan indications, trials in pediatric populations and oncology studies.”

At EFGCP’s workshop, to be held June 12 at University College London, the focus will be on innovation, but also speakers will look at current regulations and their impact in complex studies, the use of big data, and the impact of technological advances, as well as gene profiling in oncology studies and requirements for laboratories taking part in clinical research. The other central theme will be quality management, including the challenges of remote audits and preparation and management of research units who will run complex studies.

According to the organizers, “Quality and innovation may not always go ‘hand in hand’; while they may be related, they are not always complimentary. Innovation is today’s ‘buzz’ word but this needs to be carefully considered and systemically incorporated for it to be successful. Quality and quality improvement practices continue to play a significant role in clinical research ensuring subject safety and data integrity.”

The campaign is being organized by the Education Working Party (EDWP), which has around six active members and is chaired by Nicky Dodsworth, vice president of global quality assurance at Premier Research, a CRO based in Reading, U.K.

The role of EDWP is to identify priority needs and primary challenges in the education and training of good clinical practice (GCP) among those involved in preparing and carrying out clinical trials. Its aim is the coordination and harmonization of educational and training programs in GCP, while appreciating that different traditions in medical and scientific education across Europe are considered when developing GCP practices. The group seeks to develop cross-national understanding through ‘train-the-trainer’ schemes.

Additionally, EFGCP is working hard to increase its membership. The group’s latest annual report showed that 142 members joined EFGCP or renewed their membership in 2016, compared with 141 members in 2015 and 237 members in 2012. Staff in Brussels contacted everybody whose membership expired in 2015 and 2016 and who had not renewed, and now it insists that each member of a working party is also an EFGCP member.

“Potential organizations that would benefit from joining EFGCP (medical societies, companies, academic institutions, etc.) were also approached to better understand the current needs of these different audiences and what the role of EFGCP could be to interact better with its members and provide the right format of services,” wrote the authors of the annual report.

In the future, the Policy and Strategy Working Party will help to achieve this goal at a larger strategic level for EFGCP. Staff have also developed a set of “elevator pitches” to present and promote EFGCP in a clear and proactive manner, and the goal for 2017 is to continue such a recruitment strategy with the support of the new website designed to reposition the EFGCP identity.

In other EFGCP news, the Ethics Working Party met in Brussels in February to discuss several topics, including the ethical aspects of development and implementation of lay summaries, as requested by the upcoming Clinical Trial Regulation.

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