What Are Decentralized Clinical Trials and Why Are They Important?

Key Takeaways
  • Historically, patients have needed to travel to physical clinical trial sites in order to participate in clinical research.

  • There’s a huge opportunity to change how we do clinical trials by incorporating decentralized elements.

  • Virtual and hybrid trials are inherently more inclusive and can improve everything from patient recruitment and trial time to patient cohort diversity and health outcomes.

  • Vault Health works with a variety of biotech and pharmaceutical companies as well as contract research organizations (CROs) in conducting fully decentralized and hybrid clinical trials.

Traditional clinical trials are often slow, expensive, and inefficient. While researchers are continually looking for ways to improve the patient and physician experience, sponsors also want to leverage innovations that will help conduct trials faster and reduce costs.  Decentralization can help in this pursuit while also preserving the continuity of care and data integrity.(1)

Defining Decentralized Clinical Trials

Decentralized clinical trials (DCT) are defined as studies “executed through telemedicine and mobile/local healthcare providers, using processes and technologies differing from the traditional clinical trial model.”(2) In DCTs, there is a large emphasis on patient-centricity to help improve recruitment, participation and retention. Visits, for example, may take place from the comfort of the patient’s home or at a more local physical trial site using telehealth or remote patient monitoring technologies instead of requiring the patient to go to a far-away medical center.

Keep in mind that DCTs don’t have to take an all-or-nothing approach. Hybrid clinical trials may include some activities or procedures that can occur at the patient’s home but still require travel to a physical trial site for other activities related to the study. 

Examples of hybrid trial elements include:

  • In-home sample collection (i.e. blood draws), vital sign measurements, or trial drug administration
  • Telemedicine and video conferencing for clinical visits or supervision of patient self-collection of samples
  • On-site visits for procedures that require major medical equipment (e.g., advanced imaging) or specific medical expertise or interventions
  • Mobile technologies (e.g., wearables) to capture real world data

Nearly 1,300 clinical trials utilizing virtual/decentralized components are projected to start in 2022 — a 28% increase from 2021, and a 93% boost from 2020.(3) Digital elements like eConsents and web-based questionnaires are some of the most commonly incorporated approaches being used to help streamline patient participation and align data collection with patient-centric endpoints. 

Decentralized Clinical Trials Offer Many Advantages

Clinical trials are necessary for bringing interventions that improve health outcomes to market. Unfortunately, more than 80% of these trials [in the U.S.] don’t start on time or close before completion due to recruitment challenges.(4) The concept of meeting patients where they are through decentralization is an effective way to address common barriers and pain points associated with clinical trials.

Key advantages of hybrid and decentralized trials include:

  • Faster trial participant recruitment, which can help reduce costs for sponsors and bring important interventions to market faster.
  • Improved trial participant engagement and retention, leading to more and better data.  
  • Greater control, convenience, and comfort for trial participants.
  • Increased diversity and inclusion of the patient population eligible for clinical trials, including those living in care deserts

These benefits apply to all trials, but especially those that are studying rare diseases, where there are fewer patients available to enroll, or they aren’t able to travel to a physical clinical site.

How Vault Power Decentralized  Clinical Trials

Vault Health’s hybrid clinical trials platform connects in-person sites and virtual care, enabling drug manufacturers and trial sponsors to bring new therapies to market faster.  The platform includes:

  • Clinical Trial Management Software
  • Telehealth
  • National Clinical Study Staff 
  • Remote Sample Collection & Diagnostics
  • At-Home Visits

We empower patients to receive care on their terms: virtually or in-person through:

  • Self-Directed or Supervised Diagnostics  
  • Asynchronous and synchronous Telehealth
  • Pharmacy & e-Prescribing
  • At Home & On-Site Patient Care

At Vault, we leverage our active patient network, which is managed by one national medical practice,  and supports a multitude of clinical studies for streamlined, continuous patient and data acquisition. Learn more here.

References

  1. Agrawal, G., Parry, B., Suresh, B., & Westra, A. (2021, September 15). COVID-19 implications for life sciences R&D: Recovery and the next normal. McKinsey & Company. https://www.mckinsey.com/industries/life-sciences/our-insights/covid-19-implications-for-life-sciences-r-and-d-recovery-and-the-next-normal
  2. (2018.) CTTI Recommendations: Decentralized Clinical Trials. Clinical Trials Transformation Initiative. https://ctti-clinicaltrials.org/wp-content/uploads/2021/06/CTTI_DCT_Recs.pdf
  3. Parkins, K. (2022, February 4). 2022 forecast: decentralised trials to reach new heights with 28% jump. Clinical Trials Arena. https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/
  4. Sanofi’s Digital Initiative Simplifies Patient Participation in Clinical Trials. (2017, February 3). Sanofi. https://www.sanofi.com/en/science-and-innovation/patient-participation-in-clinical-trials/

 

Disclaimer: This article is for general information purposes only, does not constitute medical advice, and is not intended to be relied upon for medical diagnosis or treatment. If you are experiencing a medical emergency, dial 911 immediately.

 

DISCLAIMER: This article is for general information purposes only, does not constitute medical advice and is not intended to be relied upon for medical diagnosis or treatment. If you are experiencing a medical emergency, dial 911 immediately.