Do you have scientifically proven evidence that the country you have chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources for conducting your clinical trials? Have you compared it with other eligible regions?
The US and most Western European countries remain the important centers for conducting clinical trials.
Here are some advantages of these regions
- 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 investigators do not enroll any patients and
- about one- third enroll only 5% of evaluable patients.
These challenges with developed countries are making developing countries of Asia, Latin America, Central, and Eastern Europe, the Middle East, and Africa as preferable centers for conducting clinical trials.
So, it’s obvious that all regions are not perfect destinations for conducting clinical trials. Every region has its own advantage and challenges for conducting clinical research.
Thus, it becomes crucial to identify and evaluate the best country that matches your trial needs This evaluation process can be achieved essentially by conducting efficient country-level feasibility.studies.
What is a clinical trial feasibility?
As discussed in the previous article, clinical trial feasibility is a process of evaluating the possibility of conducting a particular clinical program/trial in a specific geographic region, site, or investigators in order to achieve the overall objective of optimum project completion in terms of timelines, targets, and cost.
What is country-level feasibility?
Country-level feasibility is a process of scientific evaluation to determine the feasibility of the region/s selected to conduct a clinical trial.
Here are the top 7 key areas to explore for a successfully executed country-level clinical trial feasibility
- 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 help in selecting a perfect region for your clinical trial?
After completion of a country level feasibility, one should be able to completely understand the relevant region/s for conducting a clinical trial in the following ways.
Patient recruitment potential
Most of the clinical trials (about 80%) fail in achieving recruitment objectives as planned initially. Most of the time, this is due to poor understanding of the region or giving priority to other factors. Conducting country-level feasibility helps in understanding 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. This helps in avoiding the chances of recruitment failures.
Regulatory and ethical approvals
Initial understandings about regulatory timeline and process may differ significantly from the real practical scenario and this happens with most of the clinical trials. This may most likely be due to poor regulatory understanding. This can be sorted out by conducting a proper country-level feasibility study.
The number of sites, site infrastructure, and qualified professional availability
This is another important aspect to avoid time delays and inefficient data collection. Poorly qualified staff may require more precise monitoring and this in turn affects the costs, time, and patient recruitment efficiency. With country-level feasibility, the selection of experienced sites suitable for activation can be sorted out easily.
Regulatory benefits and incentives
Many regulators in some of the therapeutic areas and specific disease conditions such as rare diseases offer various benefits and incentives that may accelerate the clinical trial process and also provide financial benefits that may inevitably reduce the drug development costs. This can be the key game-changer while choosing a country for your clinical trial and can be evaluated by conducting a country level feasibility. Click here to learn more about the benefits and incentives provided by various regulators →
There may be differences in data acceptance due to ethnic incompatibility. For example Japan, PMDA may review the clinical trial data generated in other countries for acceptance, and may ask for an abridge trial due to ethnic differences. Hence data acceptance should be well thought before you start a clinical trial.
The expenses of labor and site fees are typically highest in developed countries compared to developing countries. Cost per patient expenses, study conduct, and regulatory expenses can be charted out before choosing a country and foreseen whether they over-weigh the study quality generated.
Clinical trial shipment & connectivity
This is an important factor while choosing countries that are not flexible for logistics or not agile for reaching sites. The sponsor can explore various channels for logistics, regional, or international logistics providers that have better accessibility.
Some tips for conducting country-level feasibility
Before you start a country level feasibility study, here are some tips to be noted
- Ideally, the country level feasibility should be started 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. This will help evaluate the scenario with better comparisons and analyses.
- Choose a flexible and simple yet efficient platform with the sophisticated comparison process
The smarter way to achieve country-level clinical trial feasibility
The key is to get quality data on the top 7 areas described earlier in the best possible time frame.
The smarter 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 to 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.
Readily available database of clinical trial investigators and sites
This will help us understand the in-depth capability of countries’ site capabilities and investigators’ potentials. Connectivity with a large pool of sites and investigators will be quite handy to assess the recruitment potential and patient retention capabilities, timelines of study startup, study conduct and completion, and even possible risks in achieving program objectives.
Credevo has access to more than 100,000 investigators and sites worldwide that can be easily explored for clinical trials in various segments, including but not limited to 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 project the probable scenario expected for the current clinical trial. Thus, a thorough understanding of regulatory processes in various countries is an essential asset to useful 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. Many factors including therapeutic area, disease prevalence, clinical trial awareness, patient incentives, insurance, recruitment approach, facilities, connectivity, and site accessibility could have an impact on the recruitment. etc. Thus, it becomes absolutely 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
This is one of the aspects often ignored by the feasibility teams since it does not normally affect the 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 receive regulatory incentives.
Credevo team continuously explores these aspects and provide 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 very helpful to understand the capability of various service providers that you can harness for your clinical trial. Mostly, 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. More than 350 service providers are connected to Credevo teams and it’s possible to utilize this connectivity in the selection of appropriate vendors.
Cost analysis & estimations based on experience
Often, cost estimates vary across countries. This is not only due to different currency and standard of living but also due to different requirements and ways to execute projects. E.g. it might be needed to budget SMO cost 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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