Conducting clinical trial feasibility is one of the first and crucial step involved in any clinical study process. Clinical trial feasibility helps in assessing the potential of investigators, country potential for conducting the trial and many more aspects involved to execute a clinical trial successfully.
What is a clinical trial feasibility?
Clinical trial feasibility is an assessment process to project likely scenarios if a clinical trial is conducted in a geographical region, site, or with certain investigators. This also helps create a most favorable path for successful project completion in terms of timelines, targets and cost.
What is the importance of conducting feasibility?
It’s estimated that more than 90% of clinical trials fail due to poor patient recruitment, inefficient investigators selection, improper region preference, poor understanding of ethical and local regulatory aspects of the selected site and region for conducting study, time delay and cost incurred due to delays.
- Conducting clinical trial feasibility minimizes these burdens incurred due to wrong assumptions and miss interpretations.
- Clinical trial feasibility helps in identifying these challenges before taking step forward.
- Feasibility studies also helps in identifying and understanding region-specific or even site/institution-specific practices and capabilities which can have an impact on overall study completion.
Significance of conducting clinical trial feasibility?
Feasibility studies are useful in all industries, including healthcare. In clinical trials perspective, a feasibility study examines the practicability of a clinical trial project in a defined scenario.
Clinical trial feasibility is one of the best tools in understanding and predicting the investigator and site performance, patient recruitment potentials, scenarios in a region/country and estimating the overall timeline and cost of study conduct.
Here are few aspects that significantly impact the study conduct and completion.
The process of selecting a location (country) with a sufficient number of quality sites and investigators is one of the most challenging tasks in conducting clinical trials. Proper region selection can not only impact the financials and monitoring resources requirements, but can also affect the credibility/acceptability of the data generated from the study.
Projecting prospective scenario helps assess the number of eligible patients for participation in the trial. This further improvise the process of selection of country / region for conducting the trial.
Qualified investigators and sites for your clinical trial
Careful selection and evaluation of investigator & site are critical for a successful clinical trial to complete within the estimated budget, proposed timelines and for generation of high quality data.
All sites or investigators may not fulfill the study requirements or be efficient to make the trial successful. Sites should demonstrate their ability to recruit the required number of subjects in the agreed recruitment period.
More than 80% of clinical trials in the united states fail to meet their patient recruitment timelines and approximately one-third (30%) of phase III study terminations are due to enrollment difficulties. These delays increase costs, deplete resources, and prolong the time to enter the market.
By executing a sound feasibility assessment, it’s possible to preempt the likely scenario in patient recruitment and make preparations to manage the challenges.
What outcomes can we expect from a feasibility?
Geography & investigator/site
With a well-designed feasibility, the sponsor will be able to clearly predict the country’s performance in the proposed study in terms of regulatory, patient pool, disease prevalence, availability of efficient investigators/sites, timelines and budget aspects.
Based on the investigators response and participation in feasibility sponsor shall compare various critical aspects for a clinical trial such as
- investigators clinical trial experience,
- patient recruitment tract of the investigators/sites,
- site infrastructure (staff, equipment, etc),
- feasibility questionnaire comparisons and
- various timeline for study completion (contract period, recruitment period etc.)
Foresight into clinical trial timelines / quality / cost aspects
A successful feasibility study shall determine and give foresight of timelines based on the site availability for conducting trial (initiation period), recruitment period, recruitment rate and treatment period.
It’s also possible to assess from a feasibility study, the possible quality of data at a particular site. Investigators experience, availability of trained technical clinical trial staff, site facilities help create a foresight of quality data that can be produced.
Traditional process to clinical trial feasibility
Conventionally, a typical clinical trial feasibility process involves
- Shortlisting prospective regions / countries
- Building database of prospective investigators and sites in each region
- Developing list of questions to be answered (Feasibility Questionnaire)
- Contacting investigators and sites with the preliminary information
- Getting responses from sites on feasibility questionnaire (FQ)
- Compiling regulatory and procedural details, including timelines
- Preparing a comprehensive clinical trial feasibility report
Practically, this process may take considerable efforts and time (few days to several months) to conduct whole process.
Due to the complexity of this process and time required, many site start up teams (generally responsible for feasibility) tend to skip over some critical steps.
choosing to go only with sites their database – potentially missing new investigators.
Or, skipping procedural details – inviting potential risks to timelines and whole project viability.
In order to avoid these hassles and still assess feasibility quickly, here are some smarter ways.
Smarter ways to clinical trial feasibility
You can fast track your feasibility with one or more of following ways
- Access ready database of investigators and sites
- Utilize ready professionally designed feasibility questionnaire
- Perform web-based feasibility
- Get access to readily available feasibility reports
Access database of investigators and sites
It saves a lot of time and cost to take help of readily available investigator database. These are prepared based on the experience and utilizing professional efforts.
With Credevo, it’s possible to reach out to more than 110,000 investigators across 25 countries.
Get ready feasibility questionnaire (FQ)
It makes the process lot simpler and easier, if you have a ready professionally designed feasibility questionnaire available.
Credevo provides a readily available FQ format for using in your feasibility studies.
Perform web-based feasibility
Conducting clinical trial feasibility just with few easy steps and making it time and cost effective are the hallmarks of web-based clinical trial feasibility process. This is made possible with modern information technology tools and experienced clinical research professionals.
Credevo offers a world-class online feasibility process for assessing clinical trial feasibility in almost all countries.
Get access to readily available feasibility reports
What faster way to expedite feasibility process than getting access to a already prepared feasibility assessment report?
Credevo makes some feasibility reports available for everyone to download and utilize
We invite you to discuss with our feasibility experts about your specific clinical trial needs.
Contact Credevo or just send us a message through social media or other means (links are given below).
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