Feasibility Studies
The ClinTec feasibility team understands the importance of thorough and accurate feasibility assessments in helping clients make important decisions regarding the design, economics and conduct of clinical studies and have a network of staff experienced in conducting feasibility assessments to assist our clients with such important strategic decisions.
Need for Feasibility Assessment
Through a feasibility assessment;
* A client can be advised on study design, right sites with right subject population, recruitment potential, EC timelines and regulatory scenarios
* Investigators capable of performing the study can be identified and selected
* Recruitment potential of the sites in selected countries in the specified time period can be assessed
* Proper study planning can be ensured
* With CROs prior experience and interaction with the site during feasibility, easier site assessment can be performed and site issues that might arise during the trial can be anticipated
* Provides room for having backup sites (identified during the feasibility assessment)
* Early study start up as high recruiting sites identified during the feasibility can be initiated early on in the study
* Feasibility report based on completed questionnaires also provides regulatory information and recommendations based on feasibility findings contributing to the success of the trial
ClinTec Feasibility Experience
These have included therapeutic areas but not limited to oncology, gastroenterology, neurology, immunology, cardiovascular diseases, respiratory medicine, psychiatry, endocrinology, dermatology, and nephrology and also medical devices.
ClinTec has experience conducting large scale feasibilities assessments covering all of Europe, Latin America, Asia, Middle East, Africa, Australia and New Zealand. One of the large-scale feasibilities has been in oncology where 348 investigators in 17 countries were contacted and 153 completed questionnaires from interested investigators received. Of this, 125 sites were selected for the study.
Feasibility Process
Depending on the requirement of the client, ClinTec performs the following types of feasibility assessments
Basic Feasibility Assessment:
This assessment tries to ascertain the viability of conducting the proposed clinical trial in the selected countries focussing primarily on the recruitment potential and prevalence of patient population. Approximately 7 to 10 days are taken to conduct a basic feasibility assessment.
Comprehensive Feasibility Assessment:
This assessment conducted over a span of 4 to 6 weeks advises the client on suitable sites with right subject population, feasibility of study design, recruitment potential, timelines of study and provides information on ethics committee, regulatory requirements, qualified and interested Investigators and staff, funding and other resources. The findings of the assessment are provided to the client in a detailed feasibility assessment report.
Process:
Upon receipt of feasibility assessment request, an initial search of available registers of clinical trials, existing ClinTec contacts and databases, recommendations from key opinion leaders is performed by the feasibility team to identify an initial list of potential Investigators with an interest in participation in study.
Members of the feasibility team then follow up on these initial leads by contacting investigators directly, via email, fax or telephone to ascertain the investigators' willingness and capability to perform the studies.
