Role of Technology in Multinational Clinical Research

Pharma Tech Outlook: Pharma Tech Magazine

Role of Technology in Multinational Clinical Research

Pharma Tech Outlook | Wednesday, December 28, 2022

Technology comes with various advantages in Multinational clinical research, such as in making multinational trials more efficient and in reaching more patients.

FREMONT, CA: One way to help clinical trials find more participants, especially diverse participants, is by going multinational, as demonstrated in the Covid-19 vaccine studies. The technology enabled research sponsors to communicate and share documents and data with multiple sites around the world, despite travel restrictions.

In addition to vaccine trials, holding trials across multiple countries can also help clinical trials with strict enrollment requirements, such as biomarker-driven oncology trials. In addition, expanding clinical trials benefits patients living in low- or middle-income countries, who have fewer treatment options.

Clinical trials can benefit from remote collaboration and distributed expertise: Sponsors of pharmaceutical trials are responsible for patient safety and quality. The performance of the trial sites that they work with must be monitored and audited. They can either send their own clinical research associates (CRAs) to monitor trials or enlist the assistance of CRO CRAs.

Monitoring has historically been a major barrier to expanding trials internationally. Multicountry trials used to be expensive and time-consuming when monitors could only visit sites in person.

However, many of these barriers have been eliminated by technology. Site data and regulatory documents can now be reviewed online by monitors with just a few clicks. The CRA can leave a message for the research site if they notice that a document needs to be updated or added.

Sponsors can also detect protocol deviations more quickly with remote monitoring. It is possible that countries may vary in their drug supply chains and in their ability to transmit samples, images, or scans, so expanding to new countries may increase this risk.

CRAs can detect protocol deviations quickly and prevent other human errors from going unreported with remote monitoring. Furthermore, managers can communicate with sites immediately about how to fix issues, making conducting trials in new countries realistic.

Technology in Multinational Trials: How Pharma Sponsors Can Use It:

Pharma sponsors can use it in multiple ways, such as in determining a standard for the study and in finding out what technology the sites are already using.

If sites don't already have the technology, providing it is a must.

Setting up training and revisions to standard operating procedures (SOPs) with the tech vendor.

Whenever organizations provide new technology to sites, seeking out vendors providing extensive training both to the organization and to the sites and who can help organizations in revising SOPs is necessary. It is essential to find a vendor who understands change management and the needs of clinical research teams when implementing new technology systems.

In addition to providing access to cutting-edge medical treatments, multinational clinical trials can improve health equity around the world.

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