Dr Michael Silverman of BioStrategics Consulting Ltd discusses five commercial considerations of clinical trial end points and their implications for the company and the drug.
The selection of an end point for a clinical trial can be a decision with critical strategic implications for a pharmaceutical or biotechnology company. On a technical level, clinical trial end points test the hypothesis that a drug’s pharmacological activity can be translated into true clinical benefit. Scientifically, they provide insights into the pathogenesis and treatment of disease. And, they serve the indispensible function of developing data in support of regulatory approval.
Yet clinical trial end points are much more than technical constructs employed in the service of a single protocol. They provide a company with important commercial and competitive tools that are otherwise unavailable. The primary end point becomes the indications statement, and the secondary end points become label claims. Indications and claims become promotional material, which can drive the size of the market, or even create new markets, or expand current uses by established drugs. So think carefully before locking in those end points: clinical trialists – talk to your marketing team, first.
Let’s assume you have some basic phase 1 and 2 clinical data on your drug with regard to safety and efficacy. Before pressing forward with the next large, expensive clinical trials, you may want to consider a few commercial questions that could help you include important measures and clinical trial end points in your clinical study:
- What is it your drug really does? How do you define it? What is the benefit it offers over existing treatments? For example, do you know or suspect you have an advantage over the standard of care treatment? If so, how do you articulate it? More critically, how to you define it in a way that translates into a clinical trial end point?
- Exactly what is the market your drug addresses? Which patients does your drug help most? How can this segment be optimally defined for the purposes of clinical trial conduct and, ultimately, the product label?
- What information would a doctor want to see to convince them to change their prescribing habits? For example, would a comparison study with the standard of care treatment have great influence, even if not necessary for regulatory approval? If so, what is the magnitude of advantage that must be shown to make your drug a relevant competitor?
- What product profile would convince a patient to “demand” this drug from their physician? How can the more “technical” clinical benefit shown in trials be communicated on a “lay” level?
- What information would insurance carriers need to convince them to include this drug in their formularies? Could it reduce overall healthcare costs? Can it replace more expensive therapy? Or show such greater benefit that it becomes the new standard of care?
I would be delighted to hear your thoughts on these issues, your approaches, or anecdotes about decisions you have faced in similar circumstances. To make comments or ask questions, click on this link.
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