Despite technological advances in pharma R&D, nearly 80 percent of all clinical studies for new products fail to finish on time, and 20 percent of those are delayed six months or longer. That failure represents more than cost overruns: it translates into a loss of $1 million a day in unrealized sales. Accounting for nearly 40 percent of the US pharma research budget-$7 billion per year-clinical trials are the weak link in the pipeline and must be accelerated to improve corporate growth and profitability.
The process of finding, screening, and enrolling large numbers of clinical trial patients simultaneously at multiple research sites is a challenge for even the largest pharma sponsors and clinical research organizations. One strategy is to contract with recruitment specialists. This article outlines the basics of a consultant-developed recruitment program and describes case studies in which recruitment agencies successfully enrolled patients in some of the most challenging recruitment situations.
Strategic Opportunity Clinical trials require strict protocols and drug regimens that cannot be rushed. But during the last five years, several recruitment consulting companies have begun to provide campaigns that accelerate patient enrollment. Those professionals understand how to translate complex clinical trial protocols into patient-responsive and clinically appropriate recruitment campaigns that enable investigators to meet their quotas sooner.Their programs use a mix of communications tools, media planning processes, field-based recruitment approaches, and program management systems to develop and model the outcomes of clinical trial patient recruitment campaigns. Such modeling leads to greater accuracy in forecasting budgets and timelines for each protocol and trial. A growing number of pharma companies are adopting the new approaches, and wisely so. In view of ImClone's recent experience, when Wall Street has been promised an approval date for a pivotal compound, it's best not to disappoint investors.
The results achieved by such initiatives vary based on therapeutic area, new chemical entity factors, site effectiveness indexes, and sponsor insight and experience. Nevertheless, when properly conducted, such initiatives allow clinical trial planners to model various resource investment scenarios, estimate specific costs, and forecast timetables. Those analyses involve factors such as therapeutic prevalence, protocol requirements, inclusion/exclusion criteria, and historical randomization rates. And they usually result in the timely enrollment of subjects and the completion of trials ahead of schedule.
The Basics Recruiting patients has become as complex and as competitive as marketing products. Some of the defining characteristics of a comprehensive recruitment program include:
Protocol review. At the outset, project leaders must conduct a thorough protocol review from clinical and general demographic perspectives, including
Planners should also evaluate the investment cost of accelerating trial completion compared with the anticipated cost of delay-without intervention from external recruitment specialists.
Funding. Project leaders need management confirmation that funding levels will match recruitment efforts and expectations. That includes the understanding that some costs may not be known at the outset of the campaign and an appreciation of the timelines and economic "leverage points" of each patient recruitment initiative.
Task force.It is important to form a task force of clinically oriented managers and those involved in the enrollment process to communicate decisions and recruitment progress between the sponsor and recruitment consultants.
Appropriate tools. Clinical trial planners must chose between a patient- or a clinic-centric enrollment focus for the study, which will then determine whether they use mass media-based (advertising) or field-based (investigator database and community referral) recruitment and retention approaches, respectively.
Milestones.Project management software is essential to help identify and plan for recruitment/study milestones, including the approval of campaign materials by institutional review boards and the timing of "deliverables" to prospective patients, PIs, and other members of the trial team. Such tools can also help refine tactics throughout the program, while customizing elements of the recruitment program to each investigator's preferences.
Data-based interaction.To be effective, enrollment programs must track each study site's response to the referrals generated by the recruitment campaign. Using that data, project leaders can make necessary changes in media choices, ad-airing strategies, and the wording of print and electronic recruitment messages.
Analyzing recruitment performance by site in real time also helps sponsors identify the top performing sites. It also delivers signs of diminishing lead generation and the need to reallocate resources, refine messages, and provide additional on-site support. As a result, more recruitment consulting firms are developing simple-to-use web-based data collection systems that make it easy for sites to input the most current data.