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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.
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:
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.
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.
Getting the word out
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.
Several factors hamper recruitment. One is the reliance on 20th century methods to recruit 21st century study volunteers.
Smorgasbord of Services
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:
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.
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.
Tracking Patient Information
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.
Further hampering the recruitment process is the dearth of patient volunteers. CenterWatch estimates that less than five percent of US residents -- four to five million -- participate in clinical trials. And many of them have already undergone a therapy from the same or a similar drug category, further decreasing the patient volunteer pool.
One way to increase the potential number of qualified study volunteers is by raising awareness about clinical trials in the remaining 95 percent of US consumers. (See "Getting the Word Out," page 83.) However, reaching that group requires a new approach, because their attention is constantly pulled in different directions by various media and the internet. But many -- nearly 22 percent or 143 million people, according to data presented at the United Nations Conference on Trade and Development in November 2002 -- are drawn to the internet. Results from the Stanford Institute for the Quantitative Study of Society indicate that every hour spent on the internet is one hour taken from traditional media. (See "Media Shift," page 88.)
Moreover, lack of positive media coverage on clinical research does little to create interest in new therapies. Rather, it fuels consumer skepticism about research, the cost of new drug development, and the pharma industry in general. At a time when competition for new study volunteers is keen, that skepticism only hinders the recruitment process.
Individuals whom recruitment strategies have successfully reached, yet have never participated in clinical trials, are likely to ask their doctors about studies. However, most practicing physicians are as nae as their patients about clinical research occurring in their area. That is because very little effort has been made to inform physicians about new therapies under development. If both groups are uncertain about such research, it is unlikely that those patients will participate in trials.
Fueled by consumer interest in the internet, several online patient recruitment companies now offer various approaches to facilitate patient recruitment and enrollment.
Some service providers strategically partner with web-based healthcare companies to link patients with clinical trials. They offer education about, and awareness of, disease states, benefits of clinical trial participation, and investigator site locations. Others offer online pre-screening as a more efficient alternative to telephone screening.
Although web-based recruitment offers the opportunity to communicate with a wider patient population, it is not a magic bullet. If not carefully integrated into the overall clinical trial process, it will have the disadvantages of other forms of mass advertising, such as geographic limitations -- no investigator sites nearby -- and large numbers of ineligible study volunteers. And consumers who receive information over the internet have one major concern similar to those of direct mail recipients: Has their medical information been accessed in order to reach them?
Companies that include web-based recruitment as part of an integrated system can apply technology to monitor the progress of trial volunteers through the entire recruitment process. Capturing study metrics in real time leverages critical recruitment information and allows companies to quickly make necessary changes in strategy or media expenditures.
Although relatively new, the market for patient recruitment has become a large and profitable business engaging many vendors with different services. (See "Smorgasbord of Services," page 84.) Yet all claim to offer solutions for expediting clinical trials.
Although many of those services may be of great value to pharma companies, they are often applied as an afterthought when a study is in trouble. In fact, the majority of clinical trials are underway before pharma companies turn to service providers for recruitment strategies. Pharma companies often keep some recruitment services in-house, or rely on clinical sites, to conserve marketing dollars. When they initiate several programs from various fronts, synergy in recruitment disappears, as do efforts to expedite clinical studies.
Unless pharma companies can overcome the strategic, economic, and managerial roadblocks to effective patient recruitment, they will continue to build, buy, and try disparate versions of recruitment and enrollment. Fragmentation limits their value.
Most recruitment agencies are advertising-centric; that is, they recruit patient volunteers mainly through print and broadcast advertising. Many have done so successfully. But because the advertising-centric model no longer reaches 21st century consumers, a new class of service providers has entered the fray, offering an integrated approach to recruitment. Such service providers have demonstrated that integrated solutions to clinical trials not only accelerate the process but that they also increase its efficiency. They offer a strategic approach, partnering with pharma companies during trial protocol development rather than waiting for the implementation stage.
Such companies have taken recruitment promotion to a new level by establishing a system that connects various recruitment strategies and measures the strategies' effectiveness from beginning to end. (See "Tracking Patient Information.") Metrics that capture patient recruitment data allow pharma companies to predict the recruitment strategy's true return on investment. (See "Predicting ROI," page 88.)
Another key differentiator of the new breed of agencies is the ability to manage the complex relationships among the pharma company, study sites, and patient volunteers. Innovative service providers employ a communication system that allows all groups to quickly review, transfer, and discuss recruitment and enrollment data rather than wait several weeks to measure recruitment and enrollment stages. (See "Tracking Referrals," page 88.)
Regardless of which agencies pharma companies work with, the primary measure of success is quantifiable results. Agencies that can provide data to keep study volunteers and sites on track, measure the results for future planning, and manage the complex relationship between the various groups give pharma companies their money's worth.
Most pharma companies struggling to bring new drugs to market agree that patient recruitment is the bottleneck in the clinical development process. As the number of compounds in the R&D pipeline increases, pharma companies will continue to experience delays. Breaking the cycle requires building a comprehensive system designed to:
That system takes into account the limited patient pool and the methods needed to reach a greater number of study volunteers. An integrated patient recruitment system incorporates:
Although pharma companies continue to seek ways to improve patient recruitment, they spend too much time on disparate and inefficient recruitment tactics. Those tactics may achieve short-term goals, but they fail to accelerate the rate of drug development.
An integrated system that combines marketing strategies with the recruitment and enrollment process may help improve the inefficiencies that pervade R&D. Pharma companies can develop internal systems, as long as they ensure that synergy occurs among all aspects of the trial process. Or pharma companies can turn to agencies with systems in place that will help move products to market faster. Those that do so stand to reap the benefits that much sooner.