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Contact

Address:
Gaea Pharma Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
United Kingdom

Tel:
+44 1625 413 900
Fax: +44 1625 413 919
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

Enrolment

Barriers / Solutions / Accelerating / Increasing patient accrual rate

As few as 1-3% of patients newly diagnosed with cancer participate in clinical trials. Slow enrolment delays the completion of many oncology clinical trials, with increased financial costs.

Gaea has identified a number of barriers to enrolment and has developed an approach that finds solutions by Sharing our Experience

The Gaea approach is effective

Two examples of our success illustrate this:

  1. Acceleration of enrolment in a pivotal phase III trial in relapsed sarcoma
  2. The effect of intervention on patient accrual in Phase III in indolent non-Hodgkin's lymphoma

Barriers to Enrolment

  • Few patients are told about clinical trials as a treatment option
  • Increased patient awareness of standard treatment, but not of other options available
  • Patient concerns about clinical trials, especially a fear of receiving placebo
  • Site issues not picked up during the evaluation visit, sites may not provide the whole picture and traditional CRO's CRAs are usually inexperienced
  • Shortfall of study co-ordinator and data-management resources at site
  • Patient numbers are based on guesses as there is a lack of site-specific databases
  • Overly enthusiastic sites take on too many studies in the same population
  • Lack of understanding of eligibility criteria, in particular how they relate to actual patients
  • Screening processes that do not reflect the realities of the clinic
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Solutions to Enrolment

  • Recognise that the principal investigators and sub-investigators are the most important drivers for patient accrual
  • Devise and implement a practical solution directed at the principal investigators and sub-investigators within a site-by-site strategy
  • Identification of steps to resolve specific site issues through interaction:

    • Workshops highlighting the study's clinical and scientific rationale
    • Brainstorming sessions to define actual patients in the practice through case history presentations

  • Close tracking of accrual performance for individual sites:

    • Correlate interactions with actual patient enrolment

  • Analyse and adjust:

    • Analyse changes in site-specific accrual rates
    • Adjust strategies and tactics to maximise enrolment

  • External support for data entry to resolve resourcing issues at sites
  • Involvement of medical advisors in analysis and strategy implementation
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Accelerating enrolment

Case1
The Sponsor's goal was 25% EU accrual into this global trial, but the accrual trajectory was only 12% of total enrolment.

The Gaea goal was over 50% EU accrual, but the actual EU enrolment was 53% of total accrual after Gaea intervention.

National (Spain, France), regional (Italy, UK) and city (Warsaw, Bratislava) case-study workshops were used to help site staff define suitable patients and to allow enrolling sites to share their best practice with non-enrolling sites.

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Increasing patient accrual rate

Gaea-led interventions improved accrual from an average of 3.8 patients per month to 13.5 patients per month by the following actions:

  • Re-assessment of study feasibility at poor-performing sites by open discussions with site PIs
  • Agreement on site actions during 'Lunch and Learn' meetings to introduce the study to other haematologists at site. The meetings also provide an opportunity for retraining and to share experience using case histories
  • Closure of poor-performing sites where direct intervention strategies did not improve performance

Case Study - the effect of intervention on patient accrual in an ongoing phase III trial in indolent NHL

  Pre-Intervention Pre-Intervention Pre-Intervention Intervention Intervention
Time since study ititiation Q4 Q5 Q6 Q7 Q8
# of patients accrued quarterly 7 7 7 12 27

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