Service Description

Implexement and execute complex Phase 1a/1b trial

What Went Well

Many sites slowed down in patient identification 2 months into starting active enrollment and in numerous cases sites did not immediately identify potential back up patients. So, when patients either failed screening or discontinued (not due any safety reasons), the sites had to go and start the patient identification and recruitment process all over again. This lost considerable time. This could have been avoided if the CRO monitoring site enrollment and patient identification had NOT assumed everything would go fine. If the sites had been asked to proactively identify and “prequalify” back up patients these delays likely could have been avoided. When asked, sites said they could have identified back up patients in many cases; but did not think the CRO wanted them to do so.

What Could Be Improved

Predicted site enrollment rate (i.e. opening of sites including contracting with site, agreeing on site budget (activity by activity)) were within initial estimates provided. The preparation of regulatory documents and the submission of protocol to the site or central IRB also went well – expedited turnaround of IRB questions, some unique IRB requirements . Bringing on board a central laboratory for blood chemistry and hematology and other supporting blood analytes was a bit underestimated but it was still ok as these subcontracted functions were on board before first patient first visit. CRO underestimated work load in validating bio-analytical assays for drug serum levels ; this cost significantly more to validate and added 3 months in time. Sites initially identified a number of potential patients to bring into trial immediately upon IRB approval; Note this was following training of site personnel in specific requirements of the protocol and certain specialized testing equipment) so initial patient starts occurred in record time following site IRB approvals.

Lessons Learned from the Experience

Open more sites for a complex trial such as this, specifically allow an overage in number of open sites (at an assumed patient enrollment rate) and allow over enrollment and recruitment early on to avoid downstream delays. and Better consider events that can impinge on pt compliance during multiple return visits, examples of this include the fact that patients, due to other commitments, might not be able to meet scheduled dosing dates. Had the protocol allowed a small window of days around targeted dosing, the need for protocol deviations could have been avoided. Also had we better anticipated up front (by asking the patient about special needs), we could have more directly help patients comply with a challenging dosing schedule. Examples of this would be asking about special needs for child care, transportation needs, greater flexibility on the part of sites to accommodate patient work schedules, travel schedules, vacation and holidays, etc.