Feasibility Studies: Methods & Reports
Delays in study startup and patient enrollment are the major contributors to cost overruns in clinical trials. A properly designed and executed feasibility study can provide a comprehensive assessment of a clinical trial’s specific challenges as well as strategies to mitigate risks before startup activities begin. Companies that use feasibility studies experience faster clinical trial accrual and significantly fewer delays in enrollment than those that forgo the assessment.
A properly conducted clinical trial feasibility study can provide information regarding:
- Investigator interest in the clinical trial concept
- Compatibility of the clinical trial treatments and assessments with current patterns of care
- Available patient population
- Likelihood of patients agreeing to participate in the clinical trial
- Potential modifications to clinical trial design and eligibility criteria to enhance enrollment
- Competing clinical trials
- Site capabilities
- Research infrastructure
- Personnel
- Equipment
- Regulatory requirements and timelines
- Local institutional review board/independent ethics committee (IRB/IEC) review timelines
- Investigator grant requirements and site contracts
- Projected patient enrollment rates
PPD works directly with clients to design a feasibility study that is appropriately tailored to the needs of the planned clinical trial or program. During the design phase of the study, clients interact with our feasibility and therapeutic area specialists to ensure that all relevant needs for the trial or program are considered.
Global Expertise and Experience
Our presence in more than 45 countries ensures that PPD has the local expertise to assess clinical trial feasibility worldwide in any therapeutic area. Global coordination of the feasibility study and utilization of PPD’s local expertise guarantee delivery of the best possible data to guide decision-making and achieve success for the planned clinical trial.
In 2008, PPD conducted 74 feasibility studies in various therapeutic areas.
Specialized Feasibility Methods
PPD uses several specialized methods to perform comprehensive feasibility assessments, including:
- Web-based survey technology using automated reporting with customizable graphic output to ensure accuracy and ease of interpretation
- Access to sites from both our investigator database and CiteLine’s™ SiteTrove, an investigator database
- Historical assessment of enrollment performance in similar clinical trials performed by PPD
- Assessment of the competitive clinical trial environment using CiteLine’s TrialTrove, a comprehensive database of upcoming and planned clinical trials worldwide and across all indications
- Use of specialized epidemiologic databases
- Access to global regulatory databases and internal regulatory metrics
Conducting the Feasibility Study
Feasibility studies at PPD are a cooperative venture between the dedicated feasibility services team, therapeutic experts and worldwide clinical management personnel. The feasibility services team is headed by a board-certified physician and includes experts in feasibility strategy, clinical operations and medical writing services.
In addition, a global project manager with expertise in feasibility study conduct and in the therapeutic area of interest is typically assigned to the study to provide ongoing contact with clients. Weekly client teleconferences can be arranged and facilitated by the global project manager to review the results of the study and determine if any modifications are required.
Customized Feasibility Report
At the conclusion of each study, PPD provides a complete feasibility report that directly and comprehensively addresses the specific information requirements of the planned trial or program. The format for the feasibility report can be customized as necessary to meet client needs. Besides providing data to support decision-making, the report includes clear, data-driven operational strategy recommendations for the successful conduct of the trial or program.
