Do you have scientific evidence that the country chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources to conduct clinical trials? Have you compared it with other eligible regions? To find answers to all these questions, you need to perform proper clinical trial feasibility.
The US and most Western European countries remain the important centers to conduct clinical trials.
Top advantages of US and most Western European countries to conduct clinical trials
- Predictable regulatory timelines
- Agile ethical processes
- Qualified and experienced staff and professionals
And, there are challenges as well, such as
- Cost to perform a study,
- 35% of delay in studies is due to patient recruitment,
- Nearly one-fifth of investigators do not enroll any patients, and
- about one-third enroll only 5% of evaluable patients.
- The challenges with developed countries are making developing countries of Asia, Latin America, Central, and Eastern Europe, the Middle East, and Africa preferable centers for conducting clinical trials.
- Every country has its pros and cons for conducting clinical research, and all regions may not be perfect destinations to conduct clinical trials.
- Thus, it becomes crucial to identify and evaluate the best country to match your trial needs. This evaluation process can be achieved essentially by performing efficient country-level feasibility.
What is clinical trial feasibility?
Clinical trial feasibility is a process of evaluating the possibility of conducting a particular clinical program/trial in a specific geographic region, site, or investigator in order to achieve the overall objective of optimum project completion in terms of timelines, targets, and cost.
What is country-level clinical trial feasibility?
Country-level feasibility is a process of scientific evaluation to determine the feasibility of the region/s to conduct a clinical trial.
Top 7 key areas to explore in country-level clinical trial feasibility
Here are the top 7 key areas to explore to execute country-level clinical trial feasibility successfully
- Patient recruitment potential
- Regulatory and ethical approval processes and their timelines
- Sites’ capabilities, qualified staff, and resource availability
- Regulatory benefits and incentives
- Confirmation on data acceptance
- Overall project costs
- Details on clinical trial shipment and connectivity
How does a country-level feasibility study help to select a perfect region for your clinical trial?
After completion of country-level feasibility, one should completely understand the relevant region/s for conducting a clinical trial in the following ways.
Patient recruitment in clinical trials: Potential
- Most of the clinical trials (about 80%) fail in achieving recruitment objectives as planned initially. Most of the time, this is due to a poor understanding of the region or giving priority to other factors.
- Conducting country-level feasibility helps understand the site’s potential, ease of recruitment, and recruitment estimates based on disease prevalence, competing trials, the number of willing patients available for recruitment, and previous similar trial experiences.
- It also helps in avoiding the chances of recruitment failures.
Regulatory and ethics approval
Initial understanding of regulatory timeline and process differs significantly from the practical scenario. It may most likely be due to poor regulatory knowledge. One can sort out it by conducting a proper country-level feasibility study.
The number of sites, site infrastructure, and qualified professional availability
It is another crucial aspect to avoid time delays and inefficient data collection. As inexperienced staff requires more precise monitoring, this, in turn, affects the costs, time, and patient recruitment efficiency. With country-level feasibility, one can identify experienced sites suitable for activation.
Regulatory benefits and incentives
- Many regulators, in specific cases, offer various benefits and incentives.
- It helps accelerate the clinical trial process and gives financial benefits that may inevitably reduce drug development costs. It can be a crucial game-changer while choosing a country for your clinical trial, and country-level feasibility can help achieve.
- There may be differences in data acceptance due to ethnic incompatibility. For example Japan, PMDA reviews the clinical trial data generated in other countries to accept and may ask for an abridge trial due to ethnic differences.
- Hence data acceptance should be well thought out before initiating a clinical trial.
The expenses of labor and site fees are typically higher in developed countries compared to developing countries. One needs to analyze cost per patient expenses, study conduct costs, and regulatory expenses can be charted out before choosing a country and foresee whether they over-weigh the data quality.
Clinical trial shipment & connectivity
It is crucial to know whether it is flexible for logistics and agile for reaching sites. The sponsor can explore various channels for logistics, regional, or international logistics providers having better accessibility.
Tips to conduct country-level clinical trial feasibility
Before you start a country level feasibility study, here are some tips to be noted
- Ideally, one needs to conduct the country level feasibility well before the protocol design and during the Clinical Development Plan (CDP)
- A multidisciplinary approach to performing the country level feasibility assessment with the best teams that include members with experience in clinical informatics and analytics, medical affairs, the given therapeutic area, and clinical operations
- Consider including aspects based on statistical analysis and not on opinions.
- Include key investigators and sites for more legitimate results
- Include regions, which you’re more assured of, along with those which you are not. It will help evaluate the scenario with better comparisons and analyses.
- Choose a flexible, simple, and efficient platform with a sophisticated comparison process.
The smarter way to achieve country-level clinical trial feasibility
The key is to explore quality data on the top 7 areas described earlier in the best possible time frame.
The smart way to fast-track the feasibility process includes having access to and utilizing one or more of the following resources.
- A ready database of investigator and sites in the countries of your choice
- Thorough understanding of the regulatory approval process in those countries
- Proven & optimized tool to ascertain current recruitment potential in the country
- Latest details on regulatory incentives and benefits currently provided for drug development in the country
- Access details of various CROs, service providers and vendors working in specific segments
- Estimations and analysis of operational cost for clinical trial conduct based on experience & latest inputs
If you have access to these resources, the best way will be to put together a comprehensive team of experts with expertise in various disciplines and start the process under the supervision of an experienced project manager.
However, if you don’t have access to these resources or experts, you can outsource this process easy to a partner with an efficient team. Click here to explore Credevo for country-level feasibility.→
Here are more details on these resources.
Site Feasibility and Selection: Readily available database of clinical trial investigators and sites
Site feasibility helps understand the in-depth capability of the site and investigators’ potential. Connectivity with a large pool of sites and investigators will help assess the recruitment potential and patient retention capabilities, study startup timelines, study conduct, and completion scenario, and even possible risks in achieving program objectives.
Credevo has access to more than 100,000 investigators and sites worldwide. One can easily explore these clinical trial sites in various therapeutic areas, such as oncology, rare diseases, dermatology, gastroenterology, ophthalmology, etc. Explore global pool of investigators and sites through Credevo →
Regulatory process and approval pathways in different countries
A regulatory team with knowledge of existing regulations in the country, practical understanding of the approval process, and awareness of possible risks can help understand the project’s probability scenario. Thus, a thorough understanding of regulatory processes in various countries is an essential asset to country-level feasibility.
To get quick support in these aspects, you can utilize the regulatory process details for clinical trials and product registrations in various countries freely available on Credevo. Alternatively,
Current recruitment potential assessment for the country
Most of the trials fail due to poor assumptions on patient recruitment. Factors like therapeutic area, disease prevalence, clinical trial awareness, patient incentives, insurance, recruitment approach, facilities, connectivity, and site accessibility impact patient recruitment. Thus, it becomes pertinent to ascertain current recruitment potential in a pool of sites from the country. However, getting unbiased and evidence-based data quickly from the sites is generally not easy.
Web-based tools used for online clinical trial feasibility can be quite useful to overcome that problem. Credevo provides a proven clinical trial feasibility tool that has helped organizations assess feasibility in multiple countries worldwide.
Alternatively, you can also get access to readily available clinical trial feasibility reports. Of course, what faster way to expedite the clinical trial feasibility process than getting access to an already prepared feasibility assessment report? 😉
Regulatory incentives and benefits currently provided for drug development in the country
It is one of the aspects often ignored by the feasibility teams since it does not normally affect clinical trial performance. However, this can be a very important factor in the selection of countries based on future incentives.
Many countries would like to promote the development of drugs and medicines in certain therapeutic areas or promote clinical trials in general. Some countries require conducting clinical trials in their country in order to encourage innovative medicines.
Credevo team continuously explores these aspects and provides details about various countries & regions. Some of the details on the following countries can be accessed below.
Access to CROs, service providers and vendors in clinical research
It is crucial to understand the capability of various service providers that you can harness for your clinical trial. Mainly, the potential of these providers varies across countries. These companies may include CROs, SMOs, logistics providers, recruitment support teams, etc. Explore how to select CROs as a small-mid size pharma→
Gaining access to these details about service providers in each country can often take months or years. The best way is to take support from experts, such as those at Credevo. Credevo connects more than 350 service providers, and it’s possible to utilize this connectivity for selecting appropriate vendors.
Cost analysis & estimations based on experience
Often, cost estimates vary across countries. It is not only due to different currencies and standards of living but also due to different requirements and ways to execute projects. For example, one might need to budget SMO costs in China, but not in Thailand.
It is, therefore, essential for the feasibility team to understand the requirements in the country, service providers to fulfill those requirements, and the best way to optimize these costs. In case of any help needed with these aspects, connect with the Credevo team.
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