-->

Don’t Miss the Latest
Life Science and Healthcare Information

When you subscribe to the d-Wise blog, you’ll get the latest
industry trends, news and tips right in your inbox!

No, thanks. I don‘t need to stay current.

Life Sciences News - Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities

Excerpt from Journal for Clinical Studies' Article "Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities" by Cathal Gallagher | February 24, 2017


The last few months have seen a battle build between the pharma industry and the EMA, following the issue of new guidance promoting greater transparency in clinical trial reporting. Specifically, ‘anonymised’ clinical study reports should now be made centrally available at the time of marketing authorisation submissions, but riskaverse manufacturers are digging in their heels. d-Wise’s Cathal Gallagher reviews recent developments and considers how the situation will play out.

policy-0070-under-the-microscope-1.png


It’s well accepted that transparency has ascended the life sciences agenda. Patient safety is sacrosanct and health authorities must be seen to do everything they can to drive up standards, improve quality and make manufacturers accountable.

The European Medicine Agency’s Policy 0070, recently formalised in published guidance, addresses this need by ‘encouraging’ life sciences brands to open up their clinical study reports (CSRs) for easier interrogation. Yet this must happen in a way that continues to respect and protect the anonymity of subjects taking part in clinical trials. This is a fine line to tread, and although the industry understands the intention, organisations are deeply concerned about the new level of risk they will now be open to. Recently these concerns have reached a crescendo, voiced loudly at industry seminars and conferences and in test cases at the law courts.

So how will this pan out, and what is companies’ best strategy for navigating the new requirements while keeping patient data safe?

Under the new EMA guidelines, now published, anonymised versions of complete CSRs should be made generally available within 60 days of an authorisation decision (positive or otherwise), hosted centrally by or for the EMA. The idea is that other researchers as well as the wider public will be able to access and interrogate the documents, without having to make a special application or wait months for a select set of information to be issued.

For life sciences manufacturers and brands this is a huge deal, and largely unwelcome – for they will gain little benefit in return for a lot of additional administrative work, and a considerable amount of risk.

Read Article Now

d-Wise's Insight on Journal for Clinical Studies' Article

Contesting EMA expectations won’t do companies any favours, certainly. EMA has already demonstrated its intention to stand its ground in the European law courts4, confirming plans to appeal against initial court rulings that decided in favour of corporate privacy.

The life sciences industry has enough battles on its hands at the moment; arguing against the greater good of patients shouldn’t be one of them.

Life Sciences Data Solutions

blur-de-identification-software
Share

About the Author

Leave a Comment