Dennis D. McDonald (ddmcd@outlook.com) is an independent consultant located in Alexandria Virginia. His services and capabilities are described here. Application areas include project, program, and data management; market assessment, digital strategy, and program planning; change and content management; social media; and, technology adoption. Follow him on Google+. He also publishes on CTOvision.com and aNewDomain.

The "Open Movement" Continues: Big Pharma Company Opens Up Access to Clinical Trial Data

The "Open Movement" Continues: Big Pharma Company Opens Up Access to Clinical Trial Data

By Dennis D. McDonald

I was serious when I suggested it would be to Apple’s advantage to open up to the public on how it is repairing its Maps app problem.

I wasn’t optimistic that Apple would take my advice. Secrecy seems ingrained at Apple and they can point to major successes over the years despite maintaining it. Still, more competitive times would seem to justify more extreme solutions. 

Clinical Trials

I therefore admit surprise when I read a news item in Science Business about GlaxoSmithKline’s decision to “open” its clinical trial data. Clinical trials for experimental drugs are expensive. They can take many years to complete. Investments are huge with no guaranteed payback. As major drug company patents run out on “cash cow” proprietary drugs, though, pharmaceuticals companies must seek the next big thing. 

This decision on GlaxoSmithKline’s part seems bold, given how secretive in the past drug compaies have been about clinical trials and how selective they have been in terms of release of the data. According to the news report,

The company says it hopes this announcement will encourage other companies sponsoring clinical trials to join in a broader system to enable greater access to industry data. GlaxoSmithKline CEO Sir Andrew Witty noted at a meeting hosted by the Wellcome Trust in London that “the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone. We need to take a different approach — one focused on partnership, collaboration and openness.”

If you read the whole article you’ll see that “open access” is not being provided to 100% of all clinical trials, just to those from a selected number of compounds being tested against tuberculosis. Also, researchers have to apply for secure access to the data. According to a search I initiated on my iPhone via Siri, over 95% of cases and deaths from tuberculosis are in developing countries (World Health Organization data). Still, this is a big deal given how secretive big pharma has been in the past. Will other companies follow suit? Perhaps. The same Science Business article notes that

GlaxoSmithKline also plans to double the funding to its Open Lab project in Tres Cantos, Spain, providing another £5 million ($US 8 million). The Open Lab began in 2010 to allow independent researchers access to GlaxoSmithKline facilities and resources to advance research on diseases of the developing world.

Granted, we’re not talking “developed world” here and Viagra. Also, there is no guarantee that making research more accessible will reduce the time it takes to perform clinical trials. But making data more accessible will mean that more eyeballs — and brains — will be looking, sifting, comparing, and analyzing. That’s good.

It’s also appropriate to point out that the term “open” is being used a lot these days to describe practices that are quite different from the more “closed” approaches to handling information than in the past.

Scholarly Journals

In the area of scholarly journal publishing, for example, there is an “open access” movement that seeks to make published research more accessible than is currently the case with a system that is dominated by high priced commercially published journals. I wrote about this in What Does “Open Access” Mean, Really? and noted out that, no matter how “open” one makes a system, it is still necessary to take into account how the costs of operating the system are being supported. Relating this comment to GlaxoSmithKline, let’s assume that other researchers do gain access to the tuberculosis clinical trials data. Who is paying their salaries? Other governments? Competing drug companies? Tax supported public universities? Federal research grants? And what happens if an outside researcher makes a valuable discovery unrelated to the purpose of the clinical trial?

Government Transparency

Also, since Obama was elected in the US, Federal government agencies in the US have been moving in fits and starts to becoming more “transparent.” I wrote about this in Has “Transparency” Concerning Federal Stimulus Funding Been a Success? Part 1 where I noted that “transparency ain’t cheap.” It costs money to be “open.” Some one has to be there to answer the phone, to respond to the email, to maintain the web page, or to package the database updates for distribution to subscribers. Maintaining “transparency” costs a lot of money. Not taking ongoing costs into account would be, in my opinion, an automatic recipe for transparency program cutbacks when money gets tight.

On balance, though, I believe that being open is generally better than being closed — as long as the costs of being open are understood. What do you think?

For more articles related to Transparency go here.

Copyright (c) 2012 by Dennis D. McDonald, Ph.D.

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