With the increasing pressure to more efficiently develop medicines, the proficient management of clinical trials has become a significant step in the drug development process.
According to the Tufts Center for the Study of Drug Development, it “now costs nearly $2.6 billion to develop and gain marketing approval for a new prescription drug.” With the demand for novel treatments rising and with that much capital on the line, clinical trials that miss their enrollment timelines will become less tolerable. Currently, it is estimated that revenue of between $600,000 and $8 million is lost for each day a clinical trial goes beyond its enrollment timeline.
In this context, the importance of sound patient recruitment strategy elevates. Patient recruitment efforts have a large impact on budgets and timelines. As industry grasps the notion that not all patients in a clinical trial come from a site’s own database, robust strategy planning and vendor outsourcing come into play.
According to ISR Reports, the number of patients who come from outside sites’ databases is increasing and is trending to increase more. It is rare that a pharmaceutical company or CRO has an in-house patient recruitment group that provides full capabilities and contains the depth of expertise required to ensure recruitment timelines are met. Although some are developing internal capabilities, in most cases some type of outsourcing is required.
When faced with outsourcing patient recruitment to a vendor, multiple factors must be considered. Obviously, you must choose your patient recruitment vendor(s) wisely and, at minimum, receive quality goods and services at agreed upon pricing throughout the terms of the written agreement or Scope of Work (SOW). Additionally, you should assign someone to oversee the deliverables and establish an ongoing communication channel. One of the key elements of a SOW is a detailed list of key performance indicators (KPI) that establish specific performance targets for major milestones. These are straightforward metrics used to quickly and easily measure the vendor’s performance against the service level expectations defined in the SOW. The KPIs are designed to indicate if the vendor is falling short of expectations.
Because there are numerous vendors that provide patient recruitment services, how do you narrow it down? Although this is a multifaceted decision process, one of the first things to do is to review your current vendors and evaluate their past performance. Look for gaps in the services offered to determine if they are particularly suited to a particular niche.
Secondly, take a hard look at and evaluate the types of services you are outsourcing to vendors to find out if there are any areas that need to be built up. For example, you may have plenty of print vendors, but as the landscape evolves and there is a need for more online capabilities, ensure you have vendors that can support online recruitment.
Thirdly, request case studies that show results of the vendors’ prior campaigns. Case studies are important; they are hard and fast proof that a vendor has successfully implemented the specific tactic and/or therapeutic area of interest to you. The ability of a patient recruitment vendor to provide metrics from past performance should be an indicator of its experience. Just because a vendor offers a service does not mean it has implemented that service successfully in the past.
Lastly, once an agreement with a vendor is signed, the most important piece of any vendor management program is ongoing communication with that vendor. The success of any relationship depends on such communication.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as principal consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to email@example.com
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