After helping a CRO win Bid Defense, daCRO were asked by the CRO and the company for help in selecting suitable sites for involvement in a proof of concept phase IIa study.
The aim was to use our experience of the Network sites to provide a number of suitable sites for Company approval.
This included the following:
- Generation of a list of prospective investigators.
- Creation & execution of confidentiality agreements with potential sites.
- Creation & assessment of feasibility questionnaire from sites.
Clinical Trial Feasibility
The clinical trial feasibility was a process of evaluating the possibility of conducting this Study in Europe.
In spite of the fact that most Western European countries remain the important centers for conducting clinical trials:
- ~35% of delay in studies is due to patient recruitment.
- Nearly 1/5 of investigators do not enrol any patients.
- About 1/3 enrol only 5% of evaluable patients.
- In most programs, only 1/3 consistently enrol patients.
These were the challenges we faced.
- A Network Advisory Committee was established.
- Significant protocol enhancements were achieved from physicians and nurses who would actually run the study.
A total of 30 sites were approached in Europe:
- 18 in the UK.
- 8 in Germany.
- 4 in France.
The feasibility assessments consisted of the following:
- Clinical aspects.
- Site demographics.
- Recruitment and retention.
- Ethical aspects.
- Site infrastructure.
A list of 8 prospective sites who could deliver these rare patients was generated.
All Sites chosen:
- Had experience to run study.
- Had a local, certified laboratory facility capable of performing all exams described in the protocol synopsis.
- Saw sufficient patients to meet eligibility criteria and therefore would enrol 20 patients within six months.
- Had no current or planned research studies with the same target population that would compete.
daCRO were able to help us provide our Client with not only a list of sites who could perform this difficult study, but also ggenerated a list of prospective investigators.
“ Access to this European Cancer Network allowed us to deliver extremely speedy feasibility assessments and governance checks within 4 weeks ”