The Rise of Decentralized Clinical Trials: 10 Companies Pushing the Field Forward

by Andrii Buvailo, PhD          Biopharma insight / Biopharma Insights

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The biotech industry has been witnessing a paradigm shift in recent years as it moves away from traditional clinical trials towards a decentralized model. Decentralized clinical trials (DCTs) leverage digital technology to streamline the process, allowing for greater flexibility, reduced costs, and improved patient outcomes. This article will explore the factors driving this transition, discuss the pros and cons of DCTs, and highlight some key examples of companies and drug candidates that have successfully adopted this innovative approach.

The Shift to Decentralized Clinical Trials

As the FDA increasingly embraces DCTs, the industry is responding by exploring new ways to conduct clinical research. Decentralized clinical trials companies are leveraging technology such as telemedicine, mobile apps, and wearables to facilitate remote data collection and monitoring. This shift is driven by the need to improve trial efficiency, reduce costs, and enhance patient accessibility.

 

Pros of Decentralized Clinical Trials

  1. Improved patient access and diversity: DCTs allow patients from various geographic locations and backgrounds to participate, leading to more representative and inclusive trials.
  2. Reduced burden on patients: Patients can participate from the comfort of their own homes, eliminating the need for frequent travel to clinical trial sites.
  3. Faster enrollment and retention: The convenience and flexibility of DCTs can lead to faster patient recruitment and reduced dropout rates.
  4. Real-time data collection: Continuous monitoring through digital devices enables real-time data collection and analysis, improving the overall quality of data.

 

Cons of Decentralized Clinical Trials

  1. Data security and privacy concerns: Protecting sensitive patient information and maintaining data integrity is critical, necessitating robust security measures.
  2. Technological barriers: Limited access to technology or connectivity issues can exclude certain patient populations or introduce bias in the results.
  3. Regulatory challenges: As DCTs are relatively new, regulatory bodies like the FDA are still developing guidelines to ensure compliance and safety.

 

Several companies have already adopted decentralized clinical trials with notable success. Science 37, a prominent DCT company, has collaborated with major pharmaceutical firms such as Novartis and Sanofi to conduct remote trials. In one particular case, their partnership with AOBiome led to the successful completion of a Phase 2b trial for a novel acne treatment, with 372 participants recruited in just three months.

Another example is Medable, which has developed a digital platform to streamline the DCT process. Their collaboration with PPD, a global contract research organization, has enabled more efficient and patient-centric trials across various therapeutic areas.

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