2009 to bring positive developments in life sciences research and development

By David Handelsman
Solutions Architect, SAS Health and Life Sciences Global Practice

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In 2008, the life sciences R&D industry struggled with decreased share prices, reduced profits and significant organizational changes, due in part to the general economic downturn. Across the industry, safety concerns continued. In addition, a newly elected US president will almost certainly influence the leadership at FDA, deferring changes in the agency’s standards or processes. The news for 2009, however, is not all gloom and doom: The industry will see positive advancements in the areas of CDISC standards (including machine-readable protocols), safety and social media.

CDISC standards continued their emergence and adoption, and the discussion has largely moved from why to when, and from what to how. In late 2008, the CDASH standards were approved, which now means that data capture elements can be standardized across the industry.

The user interfaces may still vary among studies and vendors, but behind the scenes, the data will be captured consistently. It’s expected that in 2009, the FDA will begin requiring data to be submitted as SDTM files and may additionally specify an ODM or HL7 delivery methodology. Forward-thinking companies will, however, not be looking at SDTM as just a submission standard, but as a means of bringing industry standards to the entire business process.

With consistent data capture and submission, the processes for cleaning, analyzing and submitting data can become standardized as well.

2009 will be the year that the eProtocol (or machine-readable protocol) finally gets legs beneath it.  Where the text-based protocol describes, in words, the parameters associated with a clinical trial, the eProtocol additionally defines these parameters as machine-readable components.

This means that it becomes possible to drive the business process of a clinical trial from the description of the trial itself.  The CRFs (or eCRFs) can be automatically selected and collated from a library. The edit checks can be automatically defined. The protocol violators can be automatically identified. The analysis plan can be automatically created (and can, itself, be created as machine-readable). And from there the analyses can be automatically constructed. Will all this happen in 2009? Probably not, but we’ll see significant progress being made.

Safety was an important issue in 2008 and will continue to be so in 2009. This is an extraordinarily difficult problem to solve. Industry professionals understand that no drug is 100 percent safe, yet most patients don’t understand all drugs have associated risks. This means that we need a combination of analytics (what is the risk?), education (can the patient and physician understand the risk?) and transparency (how do we know the risk assessment is accurate?). The key here is ultimately transparency.  Even if we have sound analytics and education, a lack of transparency promotes suspicion and then litigation. Until we can address each of these challenges, we’ll continue to see the industry struggle with the issue of safety.
 
In 2009, we’ll see explosive use of social media. Online communities built around diseases, social network technologies and industry issues saw significant growth in 2008. Whether you’re tweeting on Twitter, blogging (or commenting on blogs) or making friends on Facebook, there is a wealth of information available that visionary companies are already using to identify market trends – and in some cases, very early market trends. The broadest, most current, information is available online in just minutes, and companies that figure out how to mine that data will see marketplace advantages over their competitors.