The Shifting Landscapes of Clinical Trials

This article is based on Marta Motta’s DIA Annual Canadian Meeting presentation on 30 October: “Digital Health: Transforming Processes with Technology.” Contact us to learn more.

The global clinical trial market is growing, changing and evolving dramatically. In 2016, the market size was valued at $40 billion and is expected to reach $65 billion by 2025, according to a 2017 report by Grand View Research. Nearly half of these trials are conducted outside of North America.

A trial, particularly a large, global trial, needs robust technology solutions that can help coordinate, track and streamline processes while improving patient and study communications.

Key drivers impacting growth include:

Globalization of clinical trials. Trials are conducted in more and more countries to reach a larger number of patients across a wider variety of ethnicities. 

The evolution of cloud-based and mobile technologies. Technology and digital platforms continue to advance and evolve. These tools and platforms are a part of our day-to-day work and personal lives.

With these changes comes increased possibilities for a negative impact on the trial, such as data breaches or non-compliance based on a specific regions’ laws and regulations.

It is also important to ensure patient information is protected and securely stored. Therefore, companies are emphasizing the need of having documents exchanged in a protected and traceable environment.

Global Growth = More Complexities

Diverse cultures and languages add significant complexity to the clinical trial process. It changes the risk profile dramatically. To ensure the most time and cost-effective process is very important to plan every aspect of a trial as early as possible. In addition, global clinical trials result in multiple vendors across multiple global sites.

How can you plan for these complexities? 

  • Build in time to streamline the communications effort.
  • Work with partners who understand the differences and complexities across regions.
  • Implement language assets and automation solutions.
  • Consider a comprehensive budgeting exercise that includes translation spend based on benchmarks, an understanding of local requirements and language adaptability.

In addition, implementing secure technology and digital tools can help reduce soft costs and improve various aspects of study communication.

  • Increase security of information. Emails are not the most secure means of communication and data exchange. A secure portal offers a layer of data protection.
  • Improved study communication. Technology can help aid in the management of multi-national site data and streamline communication and data flow across sites.
  • Easier (but secure) access to information. It’s also important to consider that trials last for many years. Therefore, it becomes even more crucial to maintain data in an easy to track and easy to access manner.

All these improvements are possible through the use of a tailored technology built around those specific needs. There are many tools that can help with faster site activation, such as language assets and automation solutions to deliver clean, consistent data across languages, keep all documents up-to-date, and manage different document workflows.

The bottom line: Clinical trials are becoming ever more complex with diverse audiences who are globally distributed. Anything we can do to reduce the time and cost of a trial, streamline communications, and increase patient engagement means therapies can be evaluated more rapidly and reach people faster

Contact Welocalize Life Sciences for information on how we can help streamline the translation of your clinical study documents.