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    Clinical trials – where to conduct them?

    Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves where to test the developed medicinal product. However, there is no easy and straightforward answer as there are no formal limits in choosing the country. In this article we would like to bring the topic of country selection for clinical trials and present some benefits of certain countries – the final choice is always up to the study sponsor after profound analysis of pros and cons.

    What should be taken into account?

    During the process of choosing a country in which to conduct the clinical trial the following points should be considered:

    • regulatory and ethical approval processes and their timelines,
    • access to a specific patient population,
    • patient recruitment potential,
    • sitescapabilities,
    • staff qualifications
    • and project costs.

    Thanks to the Clinical Trials Regulation (CTR) for drugs of human use (EU Regulation 536/2014) that entered into application on 31 January 2022, the rules required to conduct clinical trials are now the same in the entire European Union. However, still there are many different aspects in conducting clinical trials, in which even European countries could differ.

    Clinical trials – Countries to consider

    Does the new regulation in Europe mean that there is no difference which European country we choose for clinical trial? No. It should be remembered that even if the Regulation harmonizes assessment of clinical trial applications (CTA) between Member States, still there are some areas of the Regulation, which are completed by national laws e.g. language requirements, fees, need for EU legal representation, etc. Moreover, countries may differ in other characteristic aspects.

    We also do not need to limit ourselves to countries in Europe. Taking into account different aspects, there are several countries that are worth considering. Below some benefits of selected countries are listed.

    Germany

    • About 7% of all clinical trials conducted worldwide*
    • At least 45 university hospitals and 118 clinical institutes are involved in clinical trials
    • High medical, technical and ethical standards
    • Good patient recruitment rates – because of the fact, that insurance is universal in Germany, patients are unlikely to be swayed by free examinations or treatments

    France

    • About 6% of all clinical trials conducted worldwide*
    • Highly qualified healthcare personnel with strong research capabilities
    • Long list of top clinical sites with high enrollment rates across multiple therapeutic areas
    • Clinical R&D spend in France is around €5 billion, attractive tax credits available for R&D companies

    Canada

    • About 4.5% of all clinical trials conducted worldwide*
    • Over 40 research hospitals
    • Canadian regulatory agency reviewsclinical trial applications in 30 days, with CTAs for bioequivalence trials taking sometimes as little as 7 days, (in the EU, the CTA assessment following the new Regulation is 60 days)
    • Tax incentives that can reduce the net cost of R&D projects by almost 35%
    • No fees to submit a clinical trial application

    Australia

    • About 4.5% of all clinical trials conducted worldwide*
    • An ethnically diverse population – population that is capable of meeting diverse recruitment needs
    • More than 50 independent medical research institutes, 37 clinical trial networks
    • Clinical research sites of high-quality clinical facilities with state-of-the-art equipment for testing, treatment and analysis
    • Attractive R&D tax incentives for clinical trials

    What about Poland?

    In Poland about 2% of all clinical trials worldwide* are conducted, which gave more than 14 000 clinical studies between years 1999-2021. The most frequently are conducted phase III trials, then phase II. The majority of trials (60%) are of a size of 101-1000 participants. Moreover, clinical trials in Poland are characterized by:

    • High rate of patient recruitment – quite a big population, patients participating in trials usually have access to medical treatment of a higher level than is the case of standard care.
    • A considerable number of specialized medical centers clustered around main cities with well‑qualified specialists.
    • Relatively low cost of conducting clinical trials – e.g. nearly 30% less than in the USA.

    It is worth noticing that in Poland, the legislation adjusted to new EU Regulation 536/2014 has been finally adopted only recently, in January 2023. Nevertheless, this was not an obstacle for the Competent Authority to accept and assess the CTAs in accordance with the new Regulation.. Data from EMA shows that in recent year in Poland about 60 of initial clinical trial applications with full dossier were submitted in accordance with Article 5 of CTR, which is the 8th place among UE countries with the biggest number of submissions [7].

    No matter which country you choose, do not hesitate to contact us, we will facilitate the process of conducting clinical trial.

    The final decision

    During the process of making the decision which country/countries to choose for our clinical trial we should keep in mind that it is impossible to predict everything, like in 2020 the start of global pandemic – at the beginning of covid outbreak the subjects’ enrollment to clinical trials decreased of about 30%.For sure we are not able to forecast the behavior of patients, the latest research suggests that even around 40% of those who sign up for a study drop out before it completes. However, by choosing the most suitable country for our research, we could minimize the risks.

    * data for period 1999-2021 by WHO

    If you are searching for optimal country to conduct clinical trail of your product, SciencePharma will be pleased to help you. We will be glad to answer all your questions and prepare a solution tailored for your needs.


    References:

    [1] Clinical research regulatory information https://clinregs.niaid.nih.gov/country/canada

    [2] WHO database https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-trial-registrations-by-year-location-disease-and-phase-of-development

    [3] Investissement Québec (investquebec.com)

    [4] Filing of clinical trials Frequently Asked Questions https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/frequently-asked-questions-filing.html#a5

    [5] Australian Clinical Trials https://www.australianclinicaltrials.gov.au/why-conduct-clinical-trial-australia

    [6] Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, do Nascimento IJB, Alhamad HK. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020 Sep 30;10(3):878-887.

    [7] https://www.ema.europa.eu/en/documents/report/key-performance-indicators-kpis-monitor-european-clinical-trials-environment-1-31-october-2022_en.pdf

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