FEASIBILITY & SITE SELECTION
Conducting Accurate and Effective Feasibilities in Clinical Trials is
An Investment to Ensure a Successful Study
About 35% of delays in studies are due to patient recruitment, nearly one-fifth of the participating investigators do not enroll any patients and about one- third only enroll 5% of potential patients. In most programs, only one-third consistently enrolls patients. 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. Feasibilities help in identifying region-specific or even institution-specific practices which can have an impact on overall study completion.
Exom Group provides unbiased and objective feasibility assessments ranging from exploratory country and epidemiology specific data relevant to your program through to detailed protocol and site information.
We work directly with clients to design a feasibility study that is tailored to the needs of the planned clinical trial or program. We manage the study feasibility assessments through our “eStudy Feasibility & Accelerator Suite”. We help study Sponsors identify solutions to mitigate the costs and risks associated with a particular trial. In a true sense, an accurate and effective feasibility is an investment to ensure a successful study.
THREE TYPES OF FEASIBILITIES
- Ethical and Regulatory: Program feasibilities aim towards finding overall time for clinical trial approval, particular regulatory requirements which can affect decision related to placing of the study etc
- Medical: Disease frequency, prevalence of program-specific patient population, nature of existing treatment patterns or guidelines, presence of alternative drugs and treatments.
Study level feasibilities are more customized towards assessing whether a particular clinical study can be conducted in a country or region.
This relates to the epidemiological data on the study specific population in terms of stage of disease, availability of standard care (in terms of background therapy and comparators), specific agreement with inclusion and exclusion criteria and acceptance of study specific procedures in line with existing medical practices.
This would include the assessment specific regulatory requirements and of the overall approval timelines to get the study ongoing.
Site or Investigator Level
- Clinical aspects: Assessing the investigator’s readiness in terms of standard care (e.g., type of drugs, dosage), actual study population vs. the patient population treated or seen by the potential investigator, readiness and acceptance of background and comparative therapy and familiarity with use of tools and technology is done in investigator level feasibility.
- Site demographics: Site demographics help us in assessing the type of clinical practice (hospital vs. out-patient), prior experience in clinical trials, and availability of study coordinators, pharmacists and nurses. This helps in assessing the ‘competency’ of the investigator/ site to conduct the clinical trial, not necessarily in terms of medical knowledge but more in terms of protocol related knowledge, personnel availability etc.
- Recruitment and retention: This is the most important section of the site feasibility. It helps us in finding the recruitment potential, specifically in anticipated subjects per month and in the entire trial. Other information collated includes ethical considerations, presence of competitive studies, prior experience in conducting similar studies etc.
- Ethical aspects: This also helps in site start-up and planning. It includes ethics committee requirements, requirements of translations etc and overall process of ethics clearance.
- Site infrastructure: Most clinical studies have specific requirements related to drug storage, processing of biological samples e.g. refrigerated centrifuge etc. Hence it is important to assess site’s capabilities related to such requirements, whether it is available at the site or needs to be procured, whether there are team members who have the relevant expertise to conduct these activities and use such tools.
- Quality: One more aspect which also needs to be evaluated is whether sites have undergone sponsor or regulatory agencies independent site audits in the past. This also helps in allocating appropriate resources and providing adequate training in the start up period.