24-9-2018 by Olav Veldhuizen
European research and innovation programmes have been extremely important for clinical trials over many years and continue to be a vital source of funding for therapy development under Horizon2020. However, navigating successful delivery of such funded projects can be challenging.
Significant support for clinical trial projects is available through H2020 Challenge calls such as, Health, Demographic Change and Wellbeing, which includes the Innovative Medicines Initiative (IMI); Eurostars; and the European and Developing Countries Clinical Trials Partnership (EDCTP).
Applications are, of course, extremely competitive and once successfully awarded the complexities of running trials within the requirements and constraints of an EU-grant need to be understood and carefully planned.
Key to all EU-funded projects is the successful submission of deliverables and the passing of milestones on time and on budget. This is ensured right from grant submission through to project completion and reporting by good planning, a realistic and informed approach, careful and informed decision making and expert project management. When it comes to projects that involve clinical trials, application of these principles is yet more critical because the challenges are even greater. Why is this?
In short, the progression of clinical trials can be unpredictable. Even the most carefully thought out timelines can be thrown off-course because of delays in local or national ethical approval, recruitment of patients, screening or retention issues, site capacity and readiness or administrative complexities. Meanwhile, for the EU as a funder, the clock keeps ticking; the deliverables are still due and funding is dependent on those milestones being met.
However, with a clear understanding of the most common pitfalls alongside informed planning and preparation, the likelihood of them occurring can be significantly reduced. The unpredictable can be predicted. And importantly, plans can be already in place to mitigate against any problems which will help to keep the trial on track.
One common area of concern, for example, is the failure to meet a recruitment target
The risk of this will have been minimized through careful feasibility enquiries and engagement with patient communities to establish whether the number of trial-participants needed to power the study is realistic. However, screening failures or the start of another trial calling on the same patient population are two factors that might affect recruitment but were not anticipated. With good project management support, additional sites can be approached and with an efficient, responsive process already in place, the initiation of a new site can be achieved with minimal delay.
Another risk that can impact on the project is a delay in ethics approval.
This can be remedied by consultation and following best practice on preparation of information materials, understanding the timing of review bodies and how to submit amendments.
Finally, if despite best efforts the trial is delayed, there is the possibility of requesting a no cost extension for the project.
Whilst these are sometimes granted, more often than not these requests are not granted. The clinical trial of course has to continue and all costs from the trial are now for the sponsor.
Excellent project management, good preparation, realistic timelines and targets and a good close working relationship between the sponsor and partner trial sites should go a long way to delivering a successful trial within the timelines of an EU funded project.
Project management for clinical trials
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