CROS NT’s Global Head of Business Development & Marketing, Chris Hamilton, was recently interviewed by International Clinical Trials magazine regarding the European legislation on clinical data transparency, its implications and how to prepare.
ICT: New European legislation in 2016 will require summaries of trials to be made public – what will change?
Chris Hamilton (CH): There is already a register of all clinical trials, but new draft European law mandates the publication, via a publicly accessible database set up by the EMA, of summaries of trials that have reached marketing authorisation. That will give very useful information to anyone interested in a particular therapeutic area and indication.
ICT: How is the new system being received by the industry?
CH: Many large pharma companies are already making such summaries available to the public, indicating good acceptance of the initiative. What is more contentious is the promotion of making raw data available, not just the summaries. Some companies have decided to challenge the draft mandate, so it will be interesting to see what happens.
ICT: What do you think the main benefits of greater data transparency will be?
CH: The sharing of information on completed research will be a positive contributor to the overall development of medicinal products by avoiding repetition of similar studies and generating ideas for product extensions for use in other indications. Initiatives such as the publication of risk management plans will also enhance patient safety.
ICT: What about patient confidentiality and privacy – how can this be protected?
CH: All stakeholders seem committed to ensuring patient confidentiality is protected. This is one of the key topics in debating the requirements to make data, not just summaries, available to the public. I expect that sponsors will need to introduce clear guidelines on how to ensure any possible patient identifiers are removed from trial data prior to publication while maintaining the traceability of trial results.
ICT: How will the legislation impact sponsors and how should they prepare?
CH: The ultimate aim is to make it mandatory for sponsors to respond to reasonable requests from the public to access the data, not just the final results, collected during clinical trials Sponsors can prepare by establishing how and when data can be anonymised, and in what format the data needs to be held so it is easily accessible. Identifying resources to prepare the data for the EU portal will also be important.
ICT: You advocate a more centralised approach to data – why?
CH: There are significant efficiencies to be gained by centralising data for a particular product. For example, the re-use of material from one study to the next saves around 30-40% of time and cost for database setup and statistical programming. Utilising the same data collection technologies and maintaining knowledge through team continuity makes studies run more smoothly.
Centralising data also allows you to apply standard formats. Taking this approach continues to facilitate the use of various clinical CROs, but it makes more sense to keep the data with one team.
Companies that plan for a pre-market sale of their compound and intellectual property can be assured of a certain value add if they can show that all the data, analysis and reports on the drug development thus far can be located centrally in a consistent format.
ICT: Tell us about clinical data visualisation tools and how they fit in.
CH: Clinical data visualisation tools can be an important component for sponsors conducting trials that need to make more informed decisions and make sense of clinical data which could evenutally be shared publicly. They can be particualrly useful for researchers looking at completed study data.
These tools facilitate drill-down and click-through to multiple levels of detail, allowing for the analysis of specific subsets and subpopulations. They allow researchers to make crucial decisions based on the information and trends revealed.
As a CRO specialized in biometrics, CROS NT helps companies with their regulatory submissions to the EU and USA by preparing their clinical data in a reliable and traceable way. If you’d like more information on centralized biometrics, clinical data transparency or would like to consult one of our experts, please contact us.