Study Start-up Empowerment Techniques

Beth Harper
President, Clinical Performance Partners, Inc.
December 22nd, 2014

Welcome to the third blog in our site empowerment series. We pick up from the last discussion on site selection and look at how sites can continue the momentum generated from their initial empowerment efforts to facilitate the site selection process while continuing to strengthen their relationships with the sponsor/CRO.

What would an empowered site do?

Having passed the site qualification or pre-study site visit (PSSV) with flying colors (by applying all of the techniques discussed in the initial blogs of the series), the empowered site reminds the sponsor (or CRO) that the preliminary enrollment estimates previously provided will need to be confirmed once the budget is available. After all, they know that any study is feasible given enough time, money and resources. They request not only the preliminary budget but also inquire as to whether a patient recruitment organization (PRO) will be involved in the study and what patient recruitment materials /services will be provided centrally.

Ask for More Information

In addition, they proactively send the sponsor a list of information they will need answered before they spend a lot of time and effort on the start-up process. For example, the site may send their standard and “non negotiable” contract language to the sponsor along with their overhead rates or any information required by their IRB or protocol review committees.  Some sites affectionately refer to this as a “reverse feasibility” questionnaire whereby they let the sponsor know what information is needed as well as any “non negotiables” before all parties invest further effort only to face lengthy delays in the protocol, budget or contract approval process, or worse, failure to get the study approved at all.

Describe Internal Practices

Recognizing that the sponsor or CRO may not be acquainted with their internal start-up process, the empowered site also proactively provides the sponsor or CRO with a document describing their internal review and approval process. For example, the site might provide a flow chart that describes which committee approvals are required (e.g., protocol review or scientific review committee, radiation safety review committee, IRB / Ethics committee, etc.) and whether the committee review and approval process can be done in parallel with the budget and contract negation process. For some sites, the contract approval is contingent upon the budget approval, which in turn is contingent upon the internal committee approvals. Many sponsors and CROs don’t understand the site’s process nor the timelines, which results in a lot of wasted time and effort responding to requests on the status of start-up activities.

Develop a Recruitment Plan

Armed with a final protocol, a preliminary budget, and an understanding of what recruitment materials and resources will be provided by the sponsor, the empowered site reaffirms their enrollment commitment and develops a recruitment resource plan to describe:

  • The final # of patients they believe they can enroll within the enrollment time period
  • The # of patients that will come from internal vs. external sources
  • The # of patients they will need to identify and pre-screen to meet the randomization goal and the work effort required for this (i.e., the recruitment funnel analysis)
  • The tactics they will apply to recruit the patients
  • The additional materials and resources they will need to support their recruitment efforts

The recruitment resource plan is provided along with the site’s study budget to provide the necessary justification required for the recruitment budget approval. By now, the sponsor and CRO know that the site means business. They have demonstrated their interest, preparedness, and recognition of the sponsor’s need for predictable enrollment. The empowered site has moved from a preliminary feasibility estimate to a confirmed enrollment commitment that gives confidence to the sponsor and ensures the site receives the resources they need to maximize their potential.

Collectively, all of the site empowerment efforts we have described thus far should have led the sponsor and site to a much earlier, and mutual decision to accept or pass on the study opportunity so that the time and resources can be spent on studies that will truly support the ultimate end goals of the sponsor.

Read the next article of the series on site training empowerment techniques.

We also have a free webinar related to this series, titled, “Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs.”

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