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Why are multi-centre clinical observational studies still so difficult to run?
J Sandy1, N Kilpatrick, M Persson
1School of Oral & Dental Sciences, University of Bristol, Bristol, UK. jonathan.sandy@bristol.ac.uk
British Dental Journal
|July 23, 2011
Summary
Regulatory approvals for multicentre studies in the UK remain slow, hindering clinical research. Improvements to the R&D approval process are crucial for attracting future studies, particularly in cleft research.
Area of Science:
- Clinical research methodology
- Regulatory affairs in healthcare
Background:
- The UK has introduced the Integrated Research Application System (IRAS) to streamline research applications.
- Securing Research and Development (R&D) approvals is a critical bottleneck for initiating multicentre clinical studies.
Purpose of the Study:
- To evaluate the efficiency of the R&D approval process for multicentre studies in the UK.
- To highlight the impact of current approval timelines on the UK's ability to attract clinical research, using cleft research as a case example.
Main Methods:
- Analysis of the R&D approval process timelines for multicentre studies.
- Qualitative assessment based on experience within cleft research.
Main Results:
- The R&D approval process, even with IRAS, remains a significant impediment.
- Current delays in approvals risk deterring clinical research investment in the UK.
Conclusions:
- The current R&D approval system requires substantial and urgent reform.
- Enhancing the approval process is essential for maintaining the UK's position as a leading destination for clinical research, especially in specialized fields like cleft research.
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