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How Hybrid and Decentralized Technologies Impact Each Phase of the Clinical Research Journey

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The clinical trial process consists of several predefined phases designed to answer questions about a drug’s efficacy and safety, all while monitoring the care of participants along the route to approval. 

Digital advancement made possible by technology has led to a rise in the practice of clinical trial decentralization. This means that patients may complete a portion of a trial without needing to come to a trial site, which can be supplemented by home healthcare when needed. 

In this article, we’ll examine how decentralized clinical trial (DCT) technology can assist in all phases of clinical research.

Overview

Clinical research looks at how drugs impact the human body. It’s the third step in the drug development process, and it has several phases in and of itself. DCT technology can be used in various ways during each phase—offering a myriad of benefits during the trial process including increased access to potentially life-changing therapies, speed, patient-centricity, and data quality. Both the highly competitive research environment and the COVID-19 pandemic have highlighted the need for decentralized technology across research phases, and all signs show this need will continue to grow in the future. 

Phases of Clinical Trial Research

Each phase of clinical trial research has a unique purpose and seeks to answer certain questions based on the study group. The use of DCT technology will vary during each phase. 

  • Phase 0 (First-in-human): A very small group is recruited to sample the drug. 

Solutions like eConsent forms can prove quite valuable here.

  • Phase 1 (Safety and tolerability): A small volunteer group is used to sample the drug. 

Safety is a top priority, and adverse events (AEs), or reactions that can potentially harm a patient’s safety, are observed carefully. Here, remote patient monitoring can help alleviate safety concerns by filling in to provide extra vigilance. 

  • Phase 2 (Efficacy): A larger study size is used to help determine drug efficacy and additional safety concerns. DCT technology, such as remote patient monitoring, eConsent, and patient screening forms, can be beneficial during this phase.
  • Phase 3 (Registrational): This phase uses a large study group and is usually the most expensive to operate. The stakes are high, as it needs to generate evidence for approval while monitoring efficacy and AEs. A wide variety of DCT technology, depending on the goals and length of the trial, may be deployed.
  • Phase 4 (Post-approval): This post-approval phase usually takes place over a longer period of time with a larger number of participants to monitor their continued health and safety. The goals of the study will determine the best use of DCT technology during this phase. 

Common forms of DCT technology and how they’re used

While DCT products are ever-expanding, here are some of the most applicable forms of DCT technology for clinical research.

  • Digital & DCT Screening: Used to screen patients, no matter where they may be located.
  • eConsent: Expands trial access to study participants and allows for consent remotely.
  • TeleVisit: Provides the experience of visiting a clinic from a remote setting.
  • eCOA: Improves the patient experience and data quality by securely collecting and processing the study data.
  • Remote Patient Monitoring: Includes a wide variety of approved instruments used to collect patient data outside a clinical setting. 

Remember, DCT technology isn’t designed to be a one-size-fits-all approach. While there are a number of options to choose from, careful consideration of a trial’s goals, patient population, research activities, and treatments can drive a strategic selection of the most advantageous DCT technology.

Example 1: Vaccine trials benefit from the use of DCT methods based on their:

  • Need for global remote access
  • Need for fast results across a high volume of participants
  • Low operational complexity
  • High reliance on patient-reported outcomes

Example 2: The complexity of oncology trials can make them ill-suited for a fully remote trial. However, DCT tech in cancer trials can help solve for: 

  • Enrollment challenges
  • Participant and site burden
  • Long-term follow-up data collection
  • Retention of participants

At Medable, DCT technology is what we do

Tracking DCT technology and understanding when/how it can best be used during clinical research is a complex process. Offering unique solutions based on the needs of each trial, Medable’s DCT platform continues to be a choice partner for research groups. With an experienced team that understands DCT methodology inside and out, Medable knows how to strategically leverage new and emerging capabilities to achieve desired trial results.

‍Contact Medable today to see how DCT technology can benefit each phase of your next trial.