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We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive-or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation.
We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive-or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to listen to the patient, reuse of real world healthcare data can improve and maybe replace clinical trials, and pre-competitive collaborations can solve our common problems.
Sometimes such talk leads to new ideas that stick. More often they are explored briefly by a valiant few, only to fizzle out in the end. Innovation is for the bold, but the pharmaceutical research industry is restrained by risk aversion and the perceived fear of regulatory repercussions-new ideas are fine as long as we don’t deviate from the tried, true, and duly SOP’d order sanctioned by our regulatory department and quality assurance auditors. So nice idea, young whippersnapper, but let it go-you’re less likely to drown if you don’t rock the boat.
During a recent head-shaking moment mulling this conundrum I found myself recalling the classic Kurt Vonnegut story “Harrison Bergeron.” Vonnegut imagined a future where government didn’t just espouse the notion of equality, but mandated handicaps so that no individual could even have the opportunity to outclass another. Those with exceptional intelligence were required to wear headsets that disrupted their thought processes so they’d be in a state of constant confusion (some of these call these meetings in today’s world). Those blessed with beauty had to wear ugly masks. Athletes were straddled with weights to slow them down, and those with great eyesight were forced to wear glasses that would cloud their vision. This made everyone equal by bringing all down to the level of the least exceptional of them all.
Among pharmaceutical companies, it often seems we handicap ourselves with Luddite attitudes and habitual routines. We like to read about disruptive technologies that may be in the pipeline, or innovative new trial approaches like virtual trials. But the spark of innovation is eventually extinguished when we realize we need to deviate from SOPs, or undergo extensive validation of a new technology when the older one works well enough already, or that we may be trying something that a regulatory inspector might not agree with-even if some other regulator has praised such approaches in a recent presentation or hearing. It ends up taking months or years to change anything, because we need to write hundreds of pages of validation documentation, and seek endless approvals to change or even register a potential change to our hallowed processes.
But why does it have to be so difficult? We don’t have a Handicapper General assigning weights and headsets to ensure we can’t be exceptional. We don’t have laws requiring SOPs to be tedious and obtuse, and validation documents filling inches of binders. What’s really required is first, a willingness to embrace change. Then we need to think about what we plan to do in advance, and then verify we’ve done what we planned before we release the results. And all that should already be pretty familiar to anyone who’s worked on a protocol-driven study.
And maybe we need some brave souls-like the female runner with a hammer in the classic 1984 Apple commercial-to disrupt the natural order and release us from our self-administered handicaps. In Vonnegut’s story, Harrison, a dashingly handsome, athletic genius escapes from prison to burst into a live television show (of stumbling, shackled dancers) and invites one of the dancers to join him as his empress of freedom. One dancer removes her ugly mask and weights, joins him in a televised dance as they both rise in rapture 30 feet above the floor-until they’re both abruptly brought back down to earth by a shotgun blast from a government representative, Handicapper General Diana Moon Gompers.
OK, well, maybe we don’t need to read that far into the story, after all. But isn’t it time we started thinking and moving a bit more out of the box if we really want to make research soar?