A real-world data approach for bridging diversity disparities in clinical trials

[Image courtesy of Pixabay]

The lack of appropriate representation in clinical trials, particularly in terms of ethnicity and race, has been a long-standing issue that directly impacts health equity and treatment efficacy. In a 2020 analysis of the global participation in clinical trials, the Food and Drug Administration (FDA) highlighted the vast difference between enrolled participants and the global population. Of the more than 297,000 participants in clinical trials globally, 76% were white, 11% were Asian, and only 7% were Black. By comparison, 60% of the global population hails from Asia, 16% from Africa, 10% from Europe, 8% from Latin America, and just over 4% from the United States.1

The FDA has focused on addressing this issue, drafting new guidance in April 2022 aimed at increasing clinical trial enrollment from underrepresented racial and ethnic populations. This draft guidance, “Diversity Plans to Im…

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Key clinical trial considerations for the new normal and the future

Image courtesy of Phastar

A great many new and varied approaches to clinical trial management have gained ground during the COVID-19 pandemic through the help of virtualization tools, strong partnerships, and regulatory guidance. Despite the upheaval this year and last, there appears to be a silver lining. The systemic changes have enabled remarkably quick development in adapting trials to accommodate different environments. Additionally, the pharma industry has developed COVID-19 vaccines at an incredible speed. Regulatory guidance has accommodated this abrupt shift. This article will cover the critical factors needed before adapting to patient-centric clinical trials.

For starters, there are quite a few differences regarding attaining and disseminating patient-level data in a decentralized or remote trial setting versus the traditional way an in-person study is designed. Telemedicine or remote visits, for …

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Thread debuts new decentralized clinical trial offering

Cary, North Carolina–based Thread has introduced a consultative service known as Thread Adopt to support change management in decentralized clinical trials.

The service encompasses processes, tools, templates and educational functionality.

“Thread Adopt guides and empowers customers to analyze their pipeline, with a view to match decentralized solutions and services to the specific needs of their trials,” said Dr. Christopher Watson, the company’s director of consulting, in a statement.

In late August, Thread announced a partnership with Endpoint Clinical, a provider of interactive response technology for clinical trials, to help clients streamline decentralized clinical trial operations.

The partnership supports two-way integration for eConsent, screening and randomization, while providing automation of workflows across both companies’ respective platforms.

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Introducing ‘BYOP’ clinical trials

Image courtesy of Pixabay.

The term BYOD — “bring your own device” — become common in tech circles in about 2009. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is working to connect patients with local physicians to collect real-world data and execute trials.

In any event, decentralized and hybrid clinical trials continue to gain ground as the pandemic persists. The trend is elevating the role of community-based clinical trials in areas such as oncology.

Additionally, physicians are playing a growing role in spurring clinical trial recruitment, according to a recent survey from Informa Pharma Intelligence and Rare Patient Voice. Almost half (48%) of patients taking par…

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