Friday, October 19, 2012

Topic16: Greater Clinical Trial Transparency and Medical Affairs Rapid Response

GSK announced this week that it would open up its clinical trial data sets to researches who receive approval from a GSK review board.  Next year, the EMA intends to open up access to all new clinical data files that are part of a product registration filing.

I believe this is a trend that will not stop – the increasing openness of biopharma with its clinical trial data.  What does this mean for medical affairs?  I have some initial thoughts below but I would be curious to hear your perspective.

As this data becomes more open, other scientists, some perhaps not fully qualified to understand the data set, are going to review it and draw conclusions.  Since our culture has incentives for publicity in academia, expect that at least some of the scientists are going to spin the data into the scariest sounding headline they can.

The result is, I predict, a sharp rise in news stories highlighting safety risks of products, often blown out of proportion.  Nevertheless, it will ultimately fall to MA to deal with this misinformation on the scientific side.   While this can happen today, it is still fairly rare.  I believe it is going to be common place.

In order to be ahead of this, MA leaders are going to need to set up a Rapid Scientific Response capability (if they don’t already have one):

  • Identify Potential Areas Requiring Responses  –  First step is determining what potential areas require rapid scientific responses.  Start with a brainstorming exercise and prioritize to get to the top 5 to 10 topics.

  • Determine Leader of Response – For each topic area, identify who from the MA or other functions team should take the lead on coordinating the rapid scientific response

  • Identify Internal Experts and Voices – Search through the organization and determine who else has the scientific expertise and other skill sets needed to support the rapid scientific response – PR and Legal should be a part of each team

  • Develop Rapid Response Plan – Create a plan for assessing the situation, determining the outline of the response, assigning elements to team members, pulling it together, getting it reviewed and getting the message out  

The entire goal of develop the Rapid Scientific Response capability is to be able to move quickly when the event occurs and produce an accurate and complete response in as little time as possible.  Without this advanced planning, when issues hit no one is clear who should be taking the lead and how.

Do you have a plan for Rapid Scientific Response?  What other impacts do you think the increasing openness of clinical trial data will bring to MA?  Leave your thoughts in the comments section.

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