1 Boring Old Man

I got to wondering recently, how Clinical Trial Data got to be proprietary in the first place, the personal private property of the sponsor of the study, their intellectual property. In 1962, the Kefauver·Harris Amendment added proof of efficacy ["in the form of ‘adequate and well-controlled investigations’"] to the FDA’s mandate for drug approval [see Reform, Regulation, and Pharmaceuticals — The Kefauver·Harris Amendments at 50], ushering in an era of randomized placebo·controlled clinical trials. Originally, the RCTs were done in academic centers, but by the 1980s, there was a new industry involved – the Contract Research Organizations that ran and administered the Clinical Trials, usually contracted by the Pharmaceutical Sponsor of the Clinical Trial. The ticket that got the study reported in the medical peer-reviewed literature was authorship by an academic physician.

By all rights, the actual data from a Clinical Trial is generated double-blinded, so neither subject nor the people administering the trial know which subjects are on placebo and which ones are on the test medication[s] until the last person completes the study. At that point, the data is abstracted from the Clinical Report Forms [CRFs] into analysis-ready Individual Participant Data [IPD], tables of data from the subjects easily sorted into groups once the blind is broken. If things have been done properly, before then, no one knows who is taking what. In in the details…, achilles’ heel…, and the wrong compromise…, my premise has been that short of burying the study or creating a biased protocol, the distortion and corruption in Clinical Trial reporting occurs after the blind is broken, and can afflict both the Clinical Study Reports [CSRs] and the published paper. Thus, the current move to insist that the Data in Data Transparency means the data as it exists before breaking the blind in the study. Anything after the blind is broken is suspect, having been jury-rigged and distorted to a varying degree with surprising regularity.

As all of us are aware, there are any number of proposals about Data Transparency on the table involving: who can have access; how can access be obtained; what format will the access come in; what specifically can be accessed; etc. The permutations and combinations multiply almost daily. But they all hinge on who owns the data in the first place. Essentially, the pharmaceutical sponsor is assumed to be the owner [intellectual property]. While they give many reasons for wanting to maintain their ownership [subject confidentiality, confidential commercial information, etc], the bottom line is that it is theirs to control. The US FDA treats it as their property. The EU EMA treats it as their property. The signed-on Authors treat it as their property.  It makes little sense to me that they are so willing to show us their outcomes in the proxy form [a published article], but not in the form they received it in from the CRO running the study.

So I thought I’d go back to the Proprietary Data Act and see why they were given that right in the first place. Only I couldn’t find the Proprietary Data Act anywhere no matter what I put in Google®. That happens, so I wrote everyone I knew asking for leads. They kindly agreed to help, but they couldn’t quite recall – Was it Congress back in 1962? Just not sure. So they looked and couldn’t come up with anything either. So how am I going to mount a campaign to Repeal the Proprietary Data Act if I can’t even find it? I finally heard from some people-in-the-know who had obviously gone on the same Hegira and found nothing either. It just happened apparently. The pharmaceutical companies had the data from the CROs they hired, and they kept it to themselves. There is no Proprietary Data Act. Never was. I guess it’s something like staking a claim in the Klondike during the gold rush or squatter’s rights. So much for my Repeal the Proprietary Data Act Movement.