Thoughts on Global Medical Affairs
Data has always been the backbone of medical affairs. Understanding the data that underlies the company’s products and the products of the competition and understanding the prevalence and treatment data available about the disease state has always been a requirement. And, being able to summarize and explain the meaning of the data is one of the greatest values that MA brings to the organization.
But as a generator of data analysis and manager of data, most MA organizations have been passengers not drivers. Most data sets are being generated by clinical development and analyzed by statistical staff within the clinical function. Even after the product is on the market and the data generation turns from a clinical responsibility to a medical responsibility, most MA organizations still rely on these resources or the resources of outsourcers to define, manage and analyze their data.
However, as MA groups grow more sophisticated in their use of data, and as real world data sets available for analysis continue to increase in size and importance, it may become in the best interest of MA to begin developing some data science capability of their own.
Some MA organization already have their own stats staff or stats staff assigned to them but working in clinical, but in my experience this is still the exception not the rule. Instead, most organization rely on stats people internally who are not primarily focused on MA or on outsourced stats resources. There are a number of challenges with this environment. First, for the internally loaned people, most of them are not that familiar with what MA does and they are also usually not familiar with using real world data sets. Leveraging them requires bringing them up the learning curve, sometimes at the expense of time and effectiveness of the analysis.
Relying on to a large degree on outside statistical help is also very problematic. In these outsourcing situations, the cost can be high and the learning curve that you are paying for becomes the property of the outsourcer to resell to your competition. Additionally, when a non-stats person hires and manages a stats outsourcer, it is very difficult for them to understand if they are getting the best thinking out of the outsourcer and suggest other alternate directions if they feel the outsourcer is taking a less than optimal path. It is this very difficulty that led many clinical organizations, even virtual clinical organizations, to realize that they always needed some stats capability in-house, even if it was simply to manage the outsourcers. Finally, working with outsourcers makes it very difficult to answer quick, smaller “what if” questions that always seem to come up after the main analysis is complete.
Given the importance of these analysis for MA and the need to be flexible, I believe that more and more MA organizations will realize that they need their own stats capability on the MA team – focused full time on the data sets and analyses that are most relevant to the post-marketing world.
MA Data Managers
While some MA organizations already have stats, I have yet to see one that has their own data management function. Nevertheless, I am going to suggest that this will be less rare in the future. Data managers are responsible for the “care and feeding” of the databases that the stats team analyzes. A common function on clinical.
As medical affairs becomes more data sophisticated and as cutting edge groups decide to build huge repositories of real world data to perform ongoing analysis, the need for professional MA focused data managers will grow. These data managers will be more focused on the collating and cleaning of external data then their clinical counterparts and that is why I think the need for an MA specialist group will take hold.
What do you think? Does your MA team have its own stats function today? Is data sciences in the plans for the future? If you would like to leave a comment, click here and scroll down.