The clinical trial feasibility is one of the first steps in clinical trial conduct. The process includes assessing the feasibility of conducting a specific clinical program/trial in a specific geographical region to complete the project optimally in terms of timelines, targets, and cost. If the process is described in more details, it includes an assessment of the internal and environmental capacity, alignment of the clinical trial in terms of study design, a dose of investigational product, comparator, patient type, with the local environment and assessing the potential of conducting a clinical trial in a specific country. A qualitative assessment of the clinical trial feasibility provides a realistic picture of the possibility of conducting clinical trials. For local drugmaker branches and contract research organizations, this is an important part of choosing the location of the study and directly affects the choice of the trial trajectory.
There are three main types of feasibilities:
1) Program level. Concerning all planned studies in the program.
2) Study level. It is aimed only at a specific study.
3) Site level. It is aimed at conducting a specific study at a particular hospital/clinic.
In turn, in each type specialists focus on different aspects.
1) The following are assessed in the study program:
A) Ethical and regulatory requirements. The goal is to analyze the cumulative time for the approval of the clinical trial results, regulatory requirements that may affect the solution, and so on.
B) Medical aspect. The goal is to analyze the frequency of the disease, prevalence of program-specific patient population, nature of existing treatment patterns or guidelines, presence of alternative drugs and treatments.
2) In the evaluation of a particular study, attention is drawn to:
A) Clinical aspects.
B) Regulation. The goal is to analyze the overall timing of approval for a particular study, an understanding of specific regulatory requirements.
C) Technical aspects – electronic CRF, tools for randomization, etc. The goal is to assess the prior experience of usage of tools and explore possible options to overcome challenges.
D) Operational. The goal is to identify the risk of a recruitment strategy.
3) The evaluation of the site draws attention to:
A) Clinical aspects.
B) 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.
C) Recruitment and retention.
D) Ethical aspects. Includes the requirements of the ethics committee, the requirements for translations etc.
E) Site infrastructure.
X7 Research team specialists successfully cope with all levels of evaluation.
Our feasibility services include:
- Evaluation of the investigator/site
- Analysis of the speed of patient enrollment
- Possible confounding factors in patient recruitment
- Experience of the investigator/site in carrying out similar trials
- Retrospective assessment of enrollment and retention in similar studies
- Availability of qualified site personnel
- Availability of equipment/facilities required for successful trial
- Impact of study procedures on Standard of Care
- Possible additional sponsor requirements
We provide complex assessment services and predict the results of each clinical trial because the qualitatively-performed feasibility is the key to the clinical study success.