Time equals money. In the pharmaceutical development world, this axiom is literal. The financial cost of a delayed clinical trial is upwards of $680,000 per day. More significantly, the lost opportunity costs of being late to market - such as market exclusivity, leadership positioning, or thought leader and advocacy relationships - are even higher. Pharmaceutical performance and success are closely linked to the reduction of drug approval time.
Yet pharmaceutical companies can get their product to market faster and with a competitive edge with a simple - yet underused - strategy: bringing a marketing communications mindset to the implementation of clinical trial programs. Recruitment creates a significant bottleneck in the drug development process.
R&D/Marketing Roles
Traditionally, the roles of research/development and marketing communications have been clearly drawn. R&D is responsible for bringing an investigational product from pre-clinical trials through to regulatory filing. Marketing steps into the picture to create a favorable environment for the new product and to launch it into the market successfully.
One of the greatest challenges to timely drug development is recruiting study volunteers. The competition for study participants is intense because there are hundreds of clinical studies underway, a limited pool of potential volunteers, several effective treatments on the market, and the need to include more diverse populations.
Many of the same communication techniques that are successful in building brand awareness, customer loyalty and driving product demand can be applied to the clinical recruitment challenge of accelerating enrollment, building investigator loyalty and creating a climate of anticipation for a potential new drug. The most effective techniques for a particular study must be evaluated on a case-by-case basis.
Today, with burning competition in the clinical research and market arenas, the need for speed in bringing a product from clinical trials to market should be treated by the R&D drivers and marketing managers as a shared responsibility and opportunity.
Top 10 Clinical Trial Strategies
1. Plan early by anticipating recruitment challenges with strategic analysis of recruitment and retention barriers. Also, prepare and test tailored and consistent recruitment messages and tactical executions.
2. Understand your recruitment audiences and their needs, using potential volunteers and their families, study investigators and sites, advocacy groups and the media.
3. Evaluate the ROI potential of various communications tools like advertising, PR, communications training, site promotional materials, advocacy and community outreach and the Internet.
4. Mine market research data to help target productive study sites, participant populations and communications vehicles using:
- claims data;
- prescription drug utilization data;
- consumer psychographics, demographics and behavior patterns; and
- media usage patterns.
5. Unify your message and challenge the norm. Create and mobilize study "messengers" to deliver consistent and audience-relevant messages.
6. Consider outreach to diverse, minority populations.
7. Capitalize on hidden resources to shape and deliver study messages via:
- feedback from sites and participants about study retention, discontinuation drivers; and
- local health and special interest "stakeholder" advocacy groups.
8. Test pilot your recruitment advertising messages and tactics before full program roll-out.
9. Boost participant retention with proven patient compliance techniques using:
- personalized or segmented communications, one-on-one relationship marketing; and
- involve and communicate with influencers of the study participant who can affect retention.
10. Consider CTR-savvy communications experts to maximize return on your recruitment spending.
Ilyssa Levins is chairman and chief creative officerm of GCI Healthcare, a global full-service healthcare agency in New York. She is responsible for global new business development, new ventures and acquisitions. She can be reached at 212/886-3500.
Her co-author is Elizabeth Fisher-Au, SVP, GCI Healthcare director, clinical trial recruitment.