Clinical Research Goes Global: What You Need to Know

Global harmonization and transportability are essential for advancing the development of safe and effective therapies across the planet. However, biopharma development remains a realm of siloed clinical trials with too much redundancy and too little interoperability. One of the contributing factors is the accumulation of local, regional, national, and international regulations. While these are often developed in response to specific issues, they are only sometimes accompanied by thoughtful streamlining or harmonization.

Even within countries, site requirements vary across academia, biopharmaceutical companies, CROs, and beyond. Therefore, aligning and defining the most common elements of the clinical trial site requirements may provide a foundation for harmonization.

Global regulatory engagement

The FDA 's primary focus is the US population, but its impact extends globally. Other regulatory authorities include:

• The European Medicines Agency
• The National Medical Products Administration in China
• The Central Drugs Standard Control Organization in India,
• The African Medicines Agency (set up in 2019 to speed up timelines for drug approvals and improve access to treatments for infectious diseases endemic to the continent .)

The more that clinical trial regulations differ from country to country, the more difficult it will be to establish common approaches to current pressing ethical issues (Harvard Public Health Review )

While all of these regulatory authorities (and others) need to be able to stand alone, there is also a need for harmonization across them to address the inequities in access to drugs and other therapies.

Globalization of clinical trials

Over the last 20 years, we’ve seen more global studies sponsored by global foundations and government funders (e.g., Bill and Melinda Gates Foundation and Welcome Trust) and some multinational pharmaceutical companies. Trials for new therapies should be conducted globally to reduce access challenges.

However, the reality is that clinical trials, including RCTs, cannot be conducted in every country to generate specific evidence for that country’s population. This is where evidence generation using transportability analysis may play a role in the globalization of clinical research. While limited, transportability analyses may offer some evidence of external validity.

For pharma companies looking to expand the geographical reach of their clinical research, they first consider the complexities of operating across different countries and cultures. This means having an understanding of the following:

• Local regulations
• Language barriers
• Cultural nuances
• Ethical considerations

Importantly, it also requires a willingness to embrace technological advances. There needs to be an emphasis on data sharing and collaboration between stakeholders in order to improve the accuracy and efficiency of drug development.?

In a rapidly evolving world of technology, can CROs and biopharmaceutical companies justify clinging to outdated methodologies and risk missing out on the transformative power of advanced technological solutions for their global trials?

At Castor, we understand the challenge of conducting trials globally. We have worked with multinational pharmaceutical companies to enable researchers to create a trial in a matter of clicks, with easy enrollment, consent, and real-world data capture.

Our solution can improve equitable health outcomes for global decentralized and hybrid clinical programs. Contact us to learn more about our platform and how we can help you improve the accuracy and efficiency of your clinical trials.