Leading or Pre-empting?

In September 2012, the pharmaceutical industry launched TransCelerate – an organization tasked with creating common standards for clinical trials. Two weeks later, one of the industry's big players announced it would make its clinical trials data available immediately to business partners.

With TransCelerate's standards development work only barely begun, this could look like an attempt to pre-empt the eventual standards. If you put your large collection of data out into the community, then the community has to work with what you give them. There's no need for the donating company to translate its data. If the donor's formats become the de facto standard, then it will save money in perpetuity.

However, the pharma industry is dominated by a small number of big players. These leaders are likely to have a proportionately higher say in the crafting of standards than smaller players. They are also more likely to have the resources to assign to standards creation. They will certainly own the largest part of the existing data.

To take a pragmatic view, the faster members of a sector arrange to share their data, the better. Earlier sharing means earlier benefits – to organizations and their end users. The friction generated by the use of one participant's inhouse standard may be outweighed by the benefits of sharing. Also, as time goes by, it is likely that the user community – including the original donor – will press for any changes required to make the standard more effective.

From the donor company's point of view, I guess they see the release of their data as the main benefit they are giving the sector, and any implied standards pre-emption as an additional favor. This organization has presumably invested time, money and expertise in developing its clinical trials standards. Managers there will likely see the resulting formats not as local peculiarities, but as highly professional models of the clinical trials domain.

What is important is that this community continues to support and resource its shared standards efforts. Even if this early donation dominates initial standards creation, its influence will wane as development continues. Essentially, those inhouse resources previously invested in maintaining and developing an inhouse standard will become available to the wider community. The donating company will also begin to alter its own formats and practices in line with shared developments. In other words, everyone will evolve together.

Can the not-invented-here syndrome be beaten? If these unilaterally published standards are good standards, then they should be embraced and extended by the community. If not, not.  Seeking Alpha