Open Data Sharing: Turf Wars v Innovation

There is consensus around the idea that greater access to patient-level clinical data is a good thing – good for science, business and humanity. However, sharing data brings with it a host of benefits, questions and risks for the industry.



“You must imagine this scenario because it has not yet come to pass: all patient data from all clinical trials, minus patient identities, made available through an independent ‘custodian’ — an organization charged with administering access to the data based on criteria that ensure all granted requests have a ‘legitimate scientific purpose.’ Wayne Koberstein, Executive Editor, Life Science Leader - “Do the Right Thing: GSK’s Case for Data Transparency,” Oct. 2, 2013

May 2014 marked the first anniversary of the GSK data sharing initiative which saw SAS providing the ongoing support and management of a globally accessible private cloud where the pharma industry can securely collaborate around anonymized clinical trial information. GSK made the bold commitment to be the first to contribute anonymized clinical trial data and since then, the program objectives have expanded to support the goal for a larger, independent environment enabled by SAS analytics for the benefit of all pharmaceutical researchers. However, 20 months in, now is a good time to review progress made as a result of the SAS/GSK collaboration and to assess the implications and risks for the industry of sharing data.

Some industry leaders have legitimate concerns about issues of patient privacy, potential misuse of data and loss of proprietary advantage. Unless appropriate safeguards are in place, open access to clinical trial data could compromise patient privacy, enable faulty science, and be a resource-intensive burden for trial sponsors and data stewards.1

Intellectual property risks

“Individual companies want to own intellectual property and tend to want to own the process and the results of that effort; unfortunately that doesn’t work as well on the road ahead relative to what we need in relation to drug discovery and pooling research resources".

According to healthcare journalist and Forbes contributor, Dan Munro, pharma realize the benefits of collectively sharing data in a collaborative way but are wary of the inherent risks of operating within an open source framework. Speaking to eyeforpharma, he explains his opinion: “Individual companies want to own intellectual property and tend to want to own the process and the results of that effort; unfortunately that doesn’t work as well on the road ahead relative to what we need in relation to drug discovery and pooling research resources”.  He goes on to add: “There is an inherent aversion to risk within pharma and the notion that companies will not get to own the solutions in the same way as they did historically does not sit well with them. Part of the challenge in the future will be learning how competing companies and the research community can accelerate drug discovery through data sharing and collaboration in an open source way but successfully navigate the risks associated with intellectual property and ownership and the revenue opportunities accruing from those collaborations”.

Patients unwilling to wait

The other risk comes from patients themselves who have enhanced access to information and will have the ability to independently crowd source to accelerate the drug discovery process. “This really will become an emerging challenge for the industry as patients in some cases will turn to crowd sourcing to fund and investigate innovative treatments. We really need to look at how we are incenting the industry so they are encouraged to collaborate to accelerate this process – patients with fatal, rare diseases won’t wait around and are becoming increasingly proactive in the search for solutions”, Munro claims.

“I’ve seen this with a patient who had ALS which he contracted at a very young age (32). He’s highly motivated and working diligently to research new therapies for his illness, the results of which could be put into a clinical trial. I also see the pediatric area as one where there could be huge inroads made in pooling resources around drug discovery as it’s a highly emotive area and the benefits could have a significant impact relatively quickly. This is one area where historic competitors could come together in new ways to rapidly accelerate drug discovery at a conceivably much lower cost”.

GSK & SAS Update: Addressing the risks

The path to transparency is lined with questions. What information should be shared, with whom, and for what purposes? How far back in time should available data go? How do you ensure patient privacy without unduly limiting the research value of the data? And what should the platforms for access and analysis look like?

When aggregated with the visitors to the other sponsors’ sites, along with the number of research requests and enquiries made by the researcher community, SAS sees large and growing interest in this shared research model".

In an interview with Matt Gross, Business Director at the SAS Health and Life Sciences Global Practice, he updated us on progress to date: “SAS is working with 17 companies in addition to GSK, 11 of them are moving into a multiple sponsor environment, so researchers can request information from these multiple sponsors. The primary advantage of a multi-sponsor implementation for researchers is increased access to clinical trial data across multiple companies to allow greater scientific exploration, such as drug comparisons across sponsors in a single project. GSK shares a public access site called ClinicalStudyDataRequest.com with ten other sponsors.  In an eight-month period from the beginning of 2014, GSK reported that they had over 200,000 unique visitors to the site.  When aggregated with the visitors to the other sponsors’ sites, along with the number of research requests and enquiries made by the researcher community, SAS sees large and growing interest in this shared research model”. 

Gross spoke about the components Sponsors must provide when making their information available to researchers.  SAS’ Clinical Trial Data Transparency solution addresses the Researcher Access component to address the needs for all Sponsors and future entities wishing to share their data allowing them the flexibility to address their other two components as each company sees fit.

In response to risks associated with data sharing, Gross commented “the early adopters to data sharing, like GSK, have taken a very pragmatic approach about the risks. The Sponsors have invested in an environment that allows them to share their information with anyone in the world at any time but in a secure manner that provides the researcher team not only with access to the information, but with free access to the tools to analyse the data including a suite of tools from SAS.” 

When properly implemented with appropriate safeguards (e.g. while authorized researchers can access the clinical trial data, the data is segregated by company, so companies cannot access each other’s data) data transparency holds enormous benefits that far outweigh the risks. If the life sciences industry does not address the data transparency issue, regulatory authorities may require full public disclosure of clinical trials information. Full disclosure requires public access to clinical trials data, which does not limit access to researchers conducting valid scientific inquiry.

The trend toward clinical trial data transparency continues to gain momentum. Pharmaceutical companies must be proactive in execution or else be prepared to have an external regulator become the arbiter of data release and publication for trials in its jurisdiction. A proactive approach paves the way for transformational innovation, clinical trial efficiency and accelerated innovation, better health outcomes and enhanced public trust in the industry.


Dan Munro will be moderating a health IT panel at Philadelphia 2015 (Build new technology pilots with HIT innovators, to improve expand business models and improve personalization). For more information, click here.

Sources:

1: Are You Ready for Clinical Trial Data Transparency? What It Means for Your Business – and What’s Needed for a Successful Implementation, SAS Whitepaper


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