When it comes to recruiting and enrolling individuals in clinical trials, the industry's challenge is similar to the one that
General Riggs cites in his call to modernize the US Army. For clinical research, the challenge is not just about using mass
radio advertising or direct mail to recruit qualified study volunteers. It is to develop a system that integrates recruitment
strategies with the screening and enrollment process, enabling pharma companies to:
- track trial patients from the first point of contact to the end of the study
- measure the recruitment strategies' effectiveness in reaching new consumers
- adjust recruitment strategies quickly
- predict the randomization period (the time it takes to select and assign volunteers to a clinical study)
- analyze the return on investment (ROI)
Progressive communication agencies offer services that meet some, if not all, of those objectives. Pharma companies can select
offerings from various agencies and establish their own integrated system or turn to agencies that provide turnkey services.
Getting the word out
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This article discusses the many stumbling blocks that hinder the clinical trial process: fragmented services, the effect of
negative press, the difficulty of reaching new study volunteers, and site inefficiencies. Yet a new breed of communication
agencies is helping pharma sponsors to meet those challenges.
Flaws in Old Methods The call to establish an integrated system for clinical research is born of the need to accelerate drug development. CenterWatch
predicts that, during the next five years, the research and development pipeline will expand by 12 percent -- almost double
the growth rate of the past five years. In addition, large pharma companies are focusing their R&D efforts on similar therapeutic
areas, creating a high-stakes race to be the first to market.
Pharmafile, an online industry resource, reports that, taken together, US pharma companies invest approximately $7 billion
annually in clinical trials, with about $1.89 billion of that set aside for patient recruitment. But because of delays affecting
nearly 60 percent of clinical trials, that expense is expected to increase. Setbacks translate into millions of potential
dollars lost for every day a drug is delayed to market.
Smorgasbord of Services
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Several factors hamper recruitment. One is the reliance on 20th century methods to recruit 21st century study volunteers.
Traditionally, pharma companies have relied on clinical sites to initiate and manage marketing strategies that recruit subjects.
Because many of those sites are independently run by individuals or small practice groups, they often face the following challenges:
- lack of market research on how to find potential subjects and to discover what motivates them to participate in a trial
- lack of staffing to oversee marketing strategies and screening of individuals
- inability to combine recruitment resources to use marketing dollars more effectively
- difficulty in finding study volunteers who "fit" the restrictive study inclusion/exclusion criteria
Many investigator sites apply simple marketing tactics, such as bulletin board announcements and one-on-one discussions with
their own patient base to find study volunteers. Clinical sites with more resources may run 4x7-inch one-color ads in local
papers.
But such strategies are painfully slow, laborious, and inconsistent, resulting in study delays of six months to two years.
When clinical sites fail to meet targeted enrollment levels, sponsor companies often come to the rescue, investing more marketing
dollars in recruitment.
Tracking Patient Information
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A common "rescue" method is the advertising-centric model, relying on mass advertising to find volunteers. Unfortunately,
that approach is no longer sufficient to reach mobile and skeptical consumers. Furthermore, staffing limitations prevent many
investigator sites from quickly and efficiently screening and scheduling volunteers. Sponsors may spend millions of dollars
on media campaigns that recruit hundreds of study volunteers, or "pre-screened" study patients, who often "sit" on waiting
lists for several weeks before they are finally called to the clinical site. Consequently, scheduling inefficiencies at the
clinical sites can add significant time and costs to any clinical trial.
Added to that is rising pressure from regulatory bodies to increase the number of trials per NDA, creating a need for more
study volunteers per trial. Augmenting recruitment strategies only increases the bottleneck if sites cannot handle the overload
of volunteers.
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