The financial world, with its seamless global networks and 24/7 trading desks, is the technological poster child around which the pharmaceutical industry should model its systems. It's a stretch, okay? The pharmaceutical industry adores paper and worships double-data entry workflows that would be laughed out of a community bank in rural South Dakota. But a guy can dream.
On Wall Street, there is a well-worn phrase: Other People's Money. In the aftermath of various scandals, most politicians believe there are high temptations for mischief with OPM. Thus, though libertarians may object, our society has guidelines, regulations—yes, even laws about proper handling of OPM. Cavalier attitudes about managing OPM may result in a trip to a local prison (unless you're running a hedge fund, of course).
In pharma, in biotech, we have entered the era of Other People's Data. OPD. OPD in pharma is not regulated. Yet. But it is a transformative force in the life sciences. Once, the clinical trial data of Company ABC belonged to that company alone. That company decided when to release its data. Whether to release it in full or in part. No more. Trial registries and class-action lawsuits and the internet have changed everything by widely disseminating OPD.
Let's take an easy example. Merck has had to deal with a boatload of OPD around its leading painkiller. There is OPD about Vioxx from pharmacy benefit managers. There is OPD from law firms. OPD from the FDA. OPD from academic physicians not involved in the clinical trial process. And Vioxx OPD from insurers. Not getting your arms around OPD about <i>your</i> compound in a rigorous way is unwise. OPD, in short, is like a neighbor's chronically barking dog: you must learn to live with it. It is not going away.
What are the technological ramifications of OPD? In a competitive landscape, it behooves all sponsors of trials, of all sizes, to be proactive in understanding OPD. This cannot be done with Excel spreadsheets and 3x5 index cards.
OPD is not a futuristic concept. A small firm like MetaWorks, based outside Boston, works with sponsors hoping to analyze OPD in the peer-reviewed scientific literature. Likewise, an electronic data capture (EDC) supplier like San Francisco's Nextrials will sync up your safety data with the adverse-event coding engine at Galt Associates. We're sure there are many fine examples of working with OPD with efficiency and automation.
In other cases, our expectation is that working with OPD may prove to be fiendishly complex with no outcome of any assuredly useful insights at the end of the day. What needs to change? Well, we need adherence to standards. Enterprise-wide data standards will prove invaluable to working with OPD. Not just Clinical Data Interchange Standards Consortium (CDISC) standards, although those are and shall remain the most crucial. But HL7 and a bevy of other hospital, insurer and physician standards will also prove crucial, because (by definition) OPD is not generated by sponsors of clinical trials.