3 Trends I’m Watching in Clinical Research Studies

1. New moves towards increasing diversity in clinical studies

The issue of diversity in clinical trials is quite personal to me. 

Growing up in a remote area of India, access to healthcare was limited and often required traveling long distances, leaving family, friends and relatives to reach the clinics or otherwise rely on traditional remedies or self-care. Having experienced this firsthand, I feel bringing clinical trials and healthcare into the community is very important to achieving diversity in clinical trials.

There has been a lack of focus on diversification in the past, but the US Food and Drug Administration (FDA) recently posted a Draft Guidance which will become a mandate for biopharmaceutical sponsors to submit Diversity Action Plans. This is intended to increase enrollment of participants from historically underrepresented populations in clinical studies and give evidence for the intended use population.

At Teva, we are working on implementing these diversity plans for upcoming clinical studies, with study enrolment goals “disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations”.

2. Patient enrollment challenges and study accelerations

As a clinical trial leader, one of our biggest challenges is patient enrollment.

According to data published by the Tufts Center for the Study of Drug Development (CSDD), 89% of clinical trials meet their enrollment goals, but this often results in trials taking twice as long as expected. This delay largely stems from challenges in patient recruitment and retention.

The Tufts data also indicates that a significant percentage of trial sites either underperform or fail to enroll patients altogether, with about 11% of sites not enrolling any patients and 37% under enrolling, while only 39% of sites meet their target goals.

To avoid enrollment delays, we are examining the burden to patients on multiple dimensions. We are gathering insights and working to design trials that are acceptable to patients. Additionally, we aim to ensure cost neutrality to patients participating in our trials, while obviously maintaining full compliance with applicable laws, regulations and policy.

In addition, we are examining ways of reducing the site burden through early engagement with our Clinical Research Organization (CRO) partners, investigator sites and patient advocacy groups. This year, within GCO, I have developed a new group focused on site engagement and a new leader has been appointed for this group.

3. Increasing efficiency in trials using AI and Big Data

Finally, technology, including artificial intelligence (AI) and Big Data, plays a crucial role in enhancing the efficiency, accuracy and overall effectiveness of clinical trial operations.

Here are some of the key benefits it brings to the field:

• Streamlined patient recruitment and retention by appropriately selecting trial sites, identifying the trends in inclusion and exclusion criteria and helping to prevent potential screen failures
• Improved data collection and real-time monitoring of data for protocol deviation trends
• Facilitation of decentralized trials through home monitoring
• Product label development and translations for investigational medicines

We at Teva continue to leverage this technology to more efficiently conduct our clinical trial operations, gain earlier and better insights, and continue to innovate our delivery operations to be best-in-class. 

I am excited for the future and the opportunity in front of us to leverage improved and more efficient ways of working.

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Find out more:

• What are the 3 biggest elements shaping clinical development today?

• Find out why diversity in clinical trials is so important

• Be part of our work – browse career options at Teva