Cochrane Collaboration logo. Click to enlarge.
The principles of the Cochrane Collaboration should be fertile ground for opening discussion of how we can change our approach to chemical safety assessment, with implications not only for minimizing bias in data generation and review, but even for managing the overall process of ensuring all chemicals have an adequate pedigree of safety before being allowed on the market.
The 10 Principles of the Cochrane Collaboration
1. Collaboration, by internally and externally fostering good communications, open decision-making and teamwork.
2. Building on the enthusiasm of individuals, by involving and supporting people of different skills and backgrounds.
3. Avoiding duplication by good management and co-ordination to maximize economy of effort.
4. Minimizing bias, through a variety of approaches such as scientific rigour, ensuring broad participation, and avoiding conflicts of interest.
5. Keeping up to date, by a commitment to ensure that Cochrane reviews are maintained through identification and incorporation of new evidence.
6. Striving for relevance, by promoting the assessment of healthcare interventions using outcomes that matter to people making choices in health care.
7. Promoting access, by wide dissemination of the outputs of the Collaboration, taking advantage of strategic alliances, and by promoting appropriate prices, content and media to meet the needs of users worldwide.
8. Ensuring quality, by being open and responsive to criticism, applying advances in methodology, and developing systems for quality improvement.
9. Continuity, by ensuring that responsibility for reviews, editorial processes and key functions is maintained and renewed.
10. Enabling wide participation in the work of the Collaboration by reducing barriers to contributing and by encouraging diversity.
Higgins, Julian P. T.; Green, Sally (2011-08-24). Cochrane Handbook for Systematic Reviews of Interventions. Wiley Cochrane Series. Kindle Locations 591-611. Wiley Publishing. Kindle Edition.
Commentary
The big one for us is obviously #4 and we’ll be addressing this in the coming months. Perhaps less obvious but still of fundamental importance for the on-going success of the Cochrane Collaboration, however, are 1, 2, 3, 6, 8 and 10. In these are, I believe, are some thought-provoking possibilities for the future management of chemical safety assessment in Europe.
For example, building on the enthusiasm of third parties (#1 and #2). This is essential for the Cochrane Collaboration’s goal of producing a sufficient number of reviews: they don’t have the staff to do this themselves; nor do they have the budget to commission all the research. So they have to leverage the enthusiasm of individuals and third party funders in order for the reviews to happen.
This is possible because everyone recognises the need for the reviews. This means the people who want the data can be made responsible for generating it; then it is simply (!) up to the Cochrane Collaboration to ensure adequate controls are in place to ensure the reviews are consistently of unimpeachable quality.
So there might be a useful lesson here for the future conduct of chemical safety reviews in the EU. It is similarly understood and accepted that there are thousands of chemicals requiring safety assessment, while no single agency or group of risk assessors can realistically hope to get through them fast enough. Leveraging the interest of the research community must therefore be an option worth exploring.
A major challenge in replicating the Cochrane model in chemical assessment is that, unlike in the medical community concerned with treatment, the chemical research community is much smaller. And unlike the case in medicine, there are few national bodies with an interest in funding toxicological research (governments don’t spend money on environmental pollution in the same direct way they do drugs). So it is going to be difficult for EFSA/ECHA/whoever to utilise the interest of a professional research community.
The people who do want the assessments carried out are the people who want to market the chemical. In all likelihood, therefore, it is the chemical manufacturers who are the realistic source of funding for this research. As covered in #4, this necessitates some careful controls to minimise risk of bias, but there is no reason in principle why this should not happen.
The expense of doing all this research might be of concern. This may be reduced by efficiency gains in only having to do each assessment once (#3). If results are properly shared between companies and the public (it is worth mentioning that efficiency in data sharing is abetted by transparency), it might be possible to do a great deal on a relatively slim budget. How much, of course, it is only possible here to speculate – but it is worth remembering that a Cochrane review takes 2-3 people only 6-12 months to complete, so expense may not need to be fabulous.
Relevance (#6) is an important as well. How much of an issue it has been in generating public uncertainty around the safety of chemicals, and distrust in the findings of expert risk assessments, it is impossible here to say, but if risk assessments were presented in language which the public can understand, and to respond to the specific concerns the public has, then there it is possible that regulatory risk assessors increase their opportunities for winning back some of the public trust which has dissipated over the last few years. This relevance can only be achieved if wide participation (#10) is achieved.
Finally, trust and authority stem from credibility, and here there are potential lessons from the Cochrane Collaboration’s commitment to quality (#8): it’s only by doing it better than anyone else that the Collaboration has any business at all; you could say that what they are selling is the benchmark of quality in review.
The Collaboration might not be able to fund the reviews but they can be the arbiters of what constitutes good practice in review and the quality controllers of each review which is conducted (indeed, the Collaboration’s success is a demonstration of how you don’t have to do everything yourself to ensure output is good enough).
The credibility of European institutions such as the European Food Safety Authority (EFSA) is similarly dependent on them being demonstrably better than anyone else at evaluating chemical safety. So as a very final point, it would be nice to see a clearer commitment to best methodology (currently absent from, for example, EFSA’s Founding Regulations [EC 178/2002], which currently only specify collegiate, committee-based approaches to evaluating chemical safety) and a clearer strategy for how they are going to achieve this.