Collaborate and prevail: a researcher’s perspective on clinical trial data transparency

Charles Darwin is often quoted as saying that, in the long history of humankind (and animal kind too), it’s “those who learned to collaborate” that have prevailed. I’d like to think the father of modern biology would be impressed at the recent SAS Clinical Trial Data Transparency Forum, where more than 50 leaders from across the life sciences industry met to discuss sharing clinical trial data for the common good.

But, amid all the essential debate around HOW clinical data transparency can be achieved, it’s important we remember WHY we are doing it and WHAT data academic researchers need. So it was refreshing to hear from Sarah Nolan, a medical statistician at Liverpool University and the Cochrane Epilepsy Group.

In particular, Sarah gave insight into why access to complete data is so important to her work on measuring the effectiveness of epilepsy treatment by the NHS. Simply put, incomplete data leads to studies being excluded from research, causing retrieval bias and casting doubt over the reliability of the conclusions presented. Tamiflu is a recent and high profile example of just that.

So what do academic researchers need? Sarah didn’t claim to be the voice of all of academia, but she did share a comprehensive list:

  • Access to all data for all participants, anonymised only as much as necessary.
  • A single point of contact for all research and/or data access enquiries.
  • A fully transparent data request process, i.e. what’s required, how long will it take?
  • Data to be accompanied by all essential documents.
  • Data to be provided in a flexible, user-friendly format.

Achieving the above ‘ideal’ will be a long journey, but it’s one that must be taken if clinical data sharing is truly to realise the goals of open innovation: more effective medicines and a better quality of life for patients.

It is also a journey that will be infinitely easier if the burden is shared – both in terms of time and costs. GSK’s Andrew Freeman highlighted this point in his talk at the Forum. GSK is just one of the big pharmas to partner with SAS to provide researchers with the data quality, access and analytics they need in a controlled, secure way. And, importantly, the SAS Clinical Trial Data Transparency offering can be built as either a single or multi-sponsor platform, enabling unprecedented collaboration and sharing.

It’s impossible to say exactly how the quest for data transparency will evolve over the next five years, but – like Darwin – I believe we will make giant strides as long as we remember why it’s important and work together to succeed.

Download the executive summary from the 3rd SAS Clinical Data Transparency Forum to find out what steps NovoNordisk, GSK, Eli Lilly and J&J have already taken towards clinical trial data sharing. Or contact me to learn more about the SAS Clinical Trial Data Transparency solution.

 

Simon Tilley

 

 

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