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Site Support is Essential in Securing Enrollment
In planning for a clinical trial teams often begin with the selection of investigator sites based upon internally derived criteria that the team believes will result in the best possible outcomes in both enrollment and data collection. Makes perfect sense to us here at ICTS...the sites should be the driving force behind your clinical trial. It is well known that the best participants and evaluable patients in clinical trials are those that are on the patient roster at your investigator sites. Maximizing the sites' internal enrollment will result in shorting the time lines and eliminating a good deal of the cost associated with a rescue enrollment solution.
The questions we would ask are: "How are you supporting the sites' enrollment efforts?" "What is your team doing to help the sites with their enrollment initiatives?" And, more to the point, "are you being proactive with enrollment initiatives prior to site initiation"?
The relationships you develop with your investigator sites are essential to delivering cost efficient enrollment and quality evaluable patient data. As investigators, the sites each operate a business within their local community, a business that is open every week...a business that must remain profitable in order for your team to be able to use the site for your studies. Part of the business of running investigator sites is making sure that at least as many new customers (patients) engage the site as those who leave, whether due to mortality, relocation or other reasons. Investigator sites take a part of their normal business model and deliver it to your clinical trial, devoting patient treatment time, staff and other resources. A portion of each site's livelihood depends upon the study being efficient in enrollment time and profitable in terms of staff time.
Support of your sites is the primary factor influencing the sites' placement of your study in their hierarchy of studies. The longer a study takes to enroll, the further down the list your study is placed in both importance and urgency. For your study to remain important to the sites it is essential to provide adequate support in a number of different areas, each depending upon a number of factors derived from your protocol, your study team's mind set and the type of investigator sites you have chosen for your study.
Although we cannot list every detail of what types of support nor every solution, which will work for each therapeutic area, we can list some of the types of solutions you might investigate while you're planning your investigator selection:
- Screen Failure Payments (Should be proportional to protocol requirements)
- Coordinator Training (Enrollment and retention procedures, best practices, patient communication tips, etc.)
- Site advertising stipend (should vary depending upon market size of site location, helps sites with day-to-day business model)
- Site OptimizationSM Tools for study coordinators (designed to assist coordinators with identifying, engaging discussion, enrolling and retaining potential subjects)
- Study Credibility Materials (therapeutic resources, study websites, advocacy and support)
- Coordinator assistance (especially in the case of difficult to identify patient populations or intense lab value requirements)
- Physician Referral Programs (Essential in Acute treatment studies, in-hospital studies and when most patients will be coming from outside the site's practice roster)
- Consent Assistance Programs (To ensure the your study message is delivered in your preferred language and tone every time as well as ensure study participants understand study requirements, risks and procedures)
- In-study patient questionnaires (modified QOL and study specific questions designed to acquire accurate feedback)
- Centralized Enrollment Support (to fill gap left from site support initiatives and for those studies which require fast, cost-efficient, high volume)
ICTS specializes in solutions designed to support investigator sites and ensure cost and time efficient enrollment...even for the most difficult studies.
For more information, contact Michael Ohrwashel, VP of business development. (610) 365-8666. MBO@ICTS.us
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