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Working together in harmony

Medical education and clinical development: a symbiotic relationship

Paper cut outs of a team of people against a blue backgroundOver the last few years, the environment in which pharma companies operate has changed significantly. Interactions with physicians are now rigorously documented and the passing of information governed ever more tightly. The development of medicines and the wealth of data generated in the process continually evolve our knowledge of the biology of diseases, as well as how best to treat them. Communicating these advances not only benefits patients but is also a fundamental part of the successful commercialisation of any drug.

Medical education has increasingly become synonymous with continuing medical education, with the focus on physicians and other healthcare professionals (HCPs). However, in its broadest context, medical education spans a much wider range of activities and audiences. From an external perspective, HCPs need to stay up to date with the latest research and treatment modalities, payers need to ensure acceptable cost–benefit profiles of new drugs if they are to be reimbursed and patients need to be informed so that they can take an active role in treatment decisions.

Internally, pharma companies must educate their own teams, both at a global level and within affiliates. To make the right decisions, both in terms of designing clinical development plans and in delivering effective, co-ordinated marketing activities, key individuals from multiple specialties need a common and strong understanding of the disease, its treatment and the clinical and market environment. Consistent communication is as much an element of global branding as the visual elements, so medical education initiatives internally are perhaps equally important as those focused externally.

So what defines the content of a medical education programme and when should it start? Communicating the benefits of a new medicine is a must, as long as information is balanced, supportable and in context. Perhaps the most difficult aspect is what to communicate and when. Waiting until all the pieces of the jigsaw are in place is not a workable option.

From the earliest stages of clinical development, academic interest from researchers and clinicians in any new therapy is understandably strong, particularly if it raises hopes of a breakthrough in clinical treatment. To deliver on this effectively, communications plans must begin early in the development process, and then change over time, evolving to provide answers to a series of questions, many of which may not even be known at the outset. By viewing medical education in this way, it is apparent that it is intrinsically linked not only to the delivery of the clinical development plan, but also to its planning and creation.

The questions that will be important when a new medicine is evaluated by regulatory authorities must be anticipated several years in advance and the relevant endpoints built into the trials so that the information becomes available when required.

Studies need to be optimally designed with clinical needs, future information and communication requirements in mind. When this degree of foresight is achieved, the risks of being unable to answer critical questions from regulators and clinicians are surely minimised and the chances of achieving a successful product development and commercialisation must be improved.

Carol Hills
The Author

Carol Hills, director of medical marketing services, Prism Ideas
Email her at: carol.hills@prismideas.com

This article was first published in PME May/June 2010 as part of the Thought Leader series.

To comment on this article, email pme@pmlive.com

 

 

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12th May 2010

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