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
- evaluation of the target patient population
- disease prevalence within the general population
- incidence of disease based on specific protocol inclusion/exclusion criteria
- existence of other drug trials competing for similar patients
- site qualifications
- confirmation of patient accrual timetables based on prior study data.
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.
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