For years, we relied on simple questionnaires to conduct trial feasibility: identify sites likely to enroll, send out a questionnaire along with inclusion/exclusion (I/E) criteria, and request each site to fax back details on the number of likely participants. If you’re still feeling the need to obtain completed questionnaires from multiple trial sites in order to feel confident about meeting enrollment goals, it’s time to change your way of thinking. Here’s why:
The process can now be done with data-driven metrics if you contract with an organization that has access to the right data. Select a contract research organization (CRO) that effectively conducts trial feasibility driven by electronic health records. You’ll get data with more accuracy than faxed-in questionnaires.
Accuracy and Timeliness
Data-driven lists will be accurate and timely. If you’re using an organization with real-time access to information, you diminish the probability of outdated information in your trial feasibility query. You don’t need to wait for contacts at multiple sites to gather information and send it back, or be concerned about how dated their information is. A data-driven approach may save both time and money.
I/E Criteria Modification Testing
If an initial review of the data reveals that your I/E criteria may be excluding a majority of potential participants, a CRO with access to patient data will be able to test modifications to the I/E criteria and determine how many potential participants you’re likely to gain with each modification. What once may have been accomplished only through trial and error has now become a more accurate and scientific process if the organization has the data and the means to process it.
Healthcare Provider Experience
If the organization has healthcare provider experience in addition to access to data, you’ll gain from a wealth of expertise and insights beyond what used to appear in a trial feasibility questionnaire. Look for an organization that can collaborate on trial design – one with experts who not only have access to the data, but know how to interpret it. No questionnaire ever provided its insights to you on protocol design, right?
Trial design and start-up are never easy, but with the data and tools now available from provider-based CRO’s, you should be able to start your project with far fewer unknowns than ever before.