Zabir Macci, director of eCOA business strategy & sales engineering at IQVIA, describes how to navigate global regulatory guidance for successful multinational clinical trials.
Key insights:
- Multinational clinical trials uncover variabilities in results, such as gene and socioeconomic factors, and bring them forward for consideration in analysis.
- Clinical trials can become complex when conducted on a global scale as regulations vary from country to country.
- An electronic clinical outcome assessment (eCOA) is a key tool for alleviating participant burden in multinational clinical trials, used by regulators to measure the effectiveness of a treatment and capture real-time participant insights.
The rising popularity of hybrid clinical trials has created more opportunities for multinational clinical studies, uniting patients across the world to participate in research for the same disease. While the diverse trove of data yielded from these trials provides unprecedented opportunities for the innovation of breakthrough treatments, compliance can remain a challenge. Regulatory guidance is continuously evolving and can be vague in describing how data can and cannot be utilised. This becomes increasingly complex when clinical trials are conducted on a global scale as regulations vary from country to country.