Conducting clinical trial feasibility is both an art and science. The science comes from the disease area, study design, and patient population. The art comes from collation and evaluation of historical trial data and the experience to assess. The challenge for clinical researchers is to ensure a high level of clinical trial data while meeting desired timelines. In a true sense, feasibility is an investment to ensure a good study.
We apply a stepwise approach to conduct an initial feasibility – typically in the RFP stage:
An initial medical and scientific review of the protocol or synopsis to identify study parameters that may affect conduct
Utilize Trialtrove® to identify similar studies (Indication, Phase, Subject Population) for benchmarking
Cross-reference Trialpredict® to evaluate subject accrual rates from benchmark studies and compare to the desired accrual rate in the RFP
Utilize Sitetrove® to identify sites with relevant experience
Augment findings with additional databases and information sources for further site identification
Site Level Feasibility
Peachtree conducts site level feasibility and site identification – ether as a stand-alone project or part of a full-service award.
Post-Award Site Level Feasibility Process
Working in conjunction with the client project team, Peachtree develops a focused and comprehensive questionnaire that allow for the full evaluation of potential investigator interest and suitability. Sites are assessed and ranked on mutually agreed criteria across a number of key areas including:
Access to Patients: Data will be gathered on site access to sufficient patients that could support the study, including an assessment of their patient population and referral pathways taking into consideration the inclusion/exclusion criteria and protocol requirements.
Recruitment: Sites will be assessed on how they plan to meet or exceed their recruitment target. For example, their previous experience in recruiting the required patient population, the site recruitment plans, a review of site database, and experience in working with patient referral networks will all be taken into account.
Facilities/Equipment: Sites will be assessed on their access to the required equipment and facilities to support all study requirements.
Competing Studies: Sites will be evaluated by review of public domain information and by inquiring of the site on their competing trials, available patients, and available resources. We will also access SiteTrove, where sites can be checked for their ongoing participation on other studies recruiting similar patient population.
Site Staff Experience: Sites will be assessed on their experience with conducting ICH-GCP studies. Additionally, we will assess sites’ experience in participating in studies of similar indications.
Site Capacity and Resourcing: Sites will be asked to demonstrate that they have the necessary staff to conduct these studies and the level of commitment that the staff will require for the study.
Start-up Times and Processes: Sites will be evaluated on their ability to get the study started quickly, based on previous experience and the challenges identified that may slow down this process.
Our feasibility team incorporates robust follow-up (email and phone) to ensure timely questionnaire completion.
Following a comprehensive review of each investigator/site response, Peachtree stratifies the recommended sites for the study to be scheduled for either an in-person or a phone pre-study site visit in accordance with our and/or sponsor business practices. At the site qualification visit, the information collected during the Site Identification process is confirmed and a final recommendation with respect to site selection status made.