The timing was perfect. Writing projects were becoming less collaborative and more administrative. Research was left on the table in favor of honed objectives aligned with a client brand strategy, publication plan, or marketing plan. Let me clarify less you envision babies being tossed out with bath water--not all pharmaceutical companies, academic centers, medical societies or healthcare stakeholders follow their own special interests right down a rabbit hole--but to quote Lewis Carroll--“Which way you ought to go depends on where you want to get to...”
When working with smaller budgets for clients lacking the infrastructure of industry, a large academic center, or medical society--data quality and scalability are critical. What is the saying? Garbage in, garbage out? What do you do when results of half of the clinical trials are hidden. How do we know? Try looking up a few clinical trials--go ahead--we will wait. The bad news is that the information you need could be in one in over a hundreds places.
Health and Human Services recently published the Final Rule requiring guidance for registration and submission of clinical trials and their findings. Head over to clinicaltrials.gov to observe how many studies fail to provide data within the 1 year requirement. Approximately twice as many positive trials are published vs. negative findings--statistically 4 out of 5 trials are indeed breaking the law.
Universities, charities, governments, industry all conduct trials--what unites them? The culture of secrecy.
How do we fix it?
AllTrials is a movement led by patients to provide information--historic data as well as evolving clinical data. Pass it on.
AllTrials is an international initiative of Ben Goldacre, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Sense About Science USA, Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. The AllTrials petition has been signed by 89138 people and 682 organisations.
Click on the image or Clinical Trial Publication Game from the Economist to test your new drug!
The "game" is a publication bias simulator and allows perspective to see how decisions to withhold results skews medical evidence.
I recommend following OpenTrials for progress in creating transparency in clinical trials. Recently launched in beta and with Ben Goldacre, MD as a founding member, the goal is providing a “comprehensive picture of the data and documents on clinical trials conducted on medicines and other treatments around the world.”
When a new drug gets tested, the results of the trials should be published for the rest of the medical world -- except much of the time, negative or inconclusive findings go unreported, leaving doctors and researchers in the dark. In this impassioned talk, Ben Goldacre explains why these unreported instances of negative data are especially misleading and dangerous.
For example, you need to consider that injections are typically prescribed for the experienced patient--who are typically more adherent. If we compared adherence based on all patients with out regard for formulation we would be introducing bias. Looking at data with deeper granularity we now observe the influence of drug delivery and adjust our analyses.
Obviously if we all could access QuintilesIMS data resources or other proprietary databases the playing field would be level--but we can't--and it isn't. Not enough of us any way. As a journalist I have been granted access to several proprietary databases. Learned by trial and error, meeting by meeting, and connection by connection--once we access the data--what we have is information.
On the other hand--if you need a collaborative partner--lets chat.