ICREL conference (part 2)
Posted by Andrew Smith on December 2, 2008
The second plenary session of this conference on the impact of the EU Clinical Trials Directive has really provided the “meat” of the proceedings: the results of the ICREL survey themselves. Admittedly, these are currently preliminary results, and were far too detailed to discuss in full on this blog, but there were some interesting similarities between the results from the different stakeholder groups… and also some significant differences!
The key comparisons in the quantitative results were between 2003, before the Directive was implemented, and 2007. Results were reported from surveys sent to competent authorities, commercial and non-commercial sponsors, and research ethics committees.
Regulators were the group who most actively responded to the survey. They reported that applications from commercial sponsors had risen slightly over that period while those from non-commercial sponsors had declined, but that there had been a spike of non-commercial studies immediately before the Directive’s implementation. Workload had almost doubled, both for scientific involvement and for admin, and budgets had risen accordingly, although fees had increased dramatically. Changes suggested by regulators included mutual recognition of approvals from other regulators for certain types of studies, clarification on SUSAR reporting and standardising the format and content of trial applications across member states.
Ethics committees were the worst group of respondents, with fewer than 10% replying to the questionnaire. This obviously undermines some of the validity of their results, but the increases in numbers of opinions, substantial amendments and SAE/SUSAR reports were clear. There was no significant change in the times to deal with applications, but increases in the number of employees and, signifncantly, fees charged to commercial sponsors.
Over 50 commercial sponsors responded to the survey, and reported an increase of 30% in the volume of studies between 2003 and 2007. This increase was more pronounced in earlier phase work, and particularly in multi-national studies. Even though regulators and ECs reported meeting their timelines, sponsors reported an overall increase of 30% in the time from final protocol to first patient, which rose to over 90% when the data was normalised by the size of sponsor. Workload increased significantly in gaining approval, coordination and pharmacovigilance, but the most startling change was in the cost of liability insurance. While not directly related to the Directive, it was suggested that it had been used as an opportunity to increase charges by nearly 400%! When asked to propose changes to the current systems, popular suggestions included enabling a single application for multi-national studies (whether by mutual recognition or a central authorisation process), use of a Regulation to replace national interpretation when implementing future requirements, harmonisation of REC applications, timelines and criteria between member states and a general simplification and harmonisation of procedures.
Discussin the responses from non-commercial sponsors, it was noted that multidisciplinary and oncology organisations were the strongest responders. A small decrease in studies on medicinal products was reported, with increases in device and observational studies. Again, time to first patient had increased, as had the workload involved with admin, monitoring, pharmacovigilance and QA. Respondants commented that the current system was not adapted to international investigator-driven research and called for further simplification and harmonisation along with a risk-based approach to regulation and further financial support and investment in infrastructure.
Closing the session with a broader view of the data, it was noted that RECs saw a larger increase in studies than regulators, and that increases were stronger for commercial than non-commercial studies. The number of centres and countries involved in these studies had increased significantly, as had the proportion of biotech and orphan products. Timelines from protocol to first patient had increased more for commercial studies, but workload had increased more for non-commercial studies (exceept for admin activities, which increased substantially for both groups).
The afternoon of this meeting will comprise breakout discussions of these results grouped by stakeholder area, concluded by reporting back and discussion by the plenary group. I hope to report on these by the end of the day.
