Phase II: Advice and Consent
Pre–Phase II, KOLs advise on target product profile. Specifically, they assess competitive products (current and future), unmet market needs, considerations for product labeling, and avenues for differentiation. In Phase II, they provide guidance on structuring clinical trial protocols to generate credible, convincing, differentiated data in line with the needs they believe the product might address.
Phase III: Going Global
As a drug enters Phase III, brand teams typically engage influential physicians from various relevant markets. That increasingly means international markets. According to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008, more than 23,000 investigators were working on new FDA-regulated clinical trials. More than 40 percent were located outside the United States, covering 91 countries.
In this stage, password-protected online forums offer an effective way to increase the global reach of Medical Science Liaisons (MSLs) while preserving confidentiality and reinforcing the scientific nature of the online discussions.
Internet KOL portals can be used to provide KOLs with training and reference materials and for general project management of offline KOL activities, such as workshops or symposia. In addition, online forums with MSLs enable the company to collect information from KOLs, such as their perceptions of safety and efficacy data, regional market conditions, and so forth.
Similar solutions already exist for general physician communications. Industry reports claim that the next generation of the "e" relationship will expand beyond e-detailing, toward providing a truly integrated online/offline customer-service experience. Examples of service portals include http://Pfizerpro.com/, http://Merckservices.com/, and http://Rocheexchange.com/.
Given the regulatory attention to separating disease awareness from product messages, brand teams will want advice from their company's regulatory affairs, medical group, and clinical group before sharing data with KOLs. Such discussions should typically begin six months to a year before the end of Phase III.
The therapeutic-area Web site is a place where the brand team can publish concise, transparent, and fair-balance content generated by KOLs, MSLs, or a medical communications agency. Such content normally outlines the therapeutic gaps in the market and starts engaging physician audiences. This is a natural online complement to traditional publications. If the drug gets approved and aligns with one of the highlighted market gaps, adoption and ramp-up in those critical first six months postapproval will only be stronger. A password-protected section on the same site can also provide MSLs easy access to reference information when traveling. It can also provide MSLs with a convenient information warehouse, from which they can e-mail documents (approved by the company's regulatory team) to KOLs and other research physicians they interact with.