Patient Recruitment Accelerator

European Proof of Concept Phase IIA Study

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.

Results
  • 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.
Methodology

The feasibility assessments consisted of the following:

  1. Clinical aspects.
  2. Site demographics.
  3. Recruitment and retention.
  4. Ethical aspects.
  5. Site infrastructure.
  6. Quality
Results

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.
Outcomes

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 ”

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