Blog | Did you know some concerns about decentralized trials may not be warranted?

Blog: Did you know

some concerns about decentralized trials may not be warranted?

As more Sponsors think about trying ‘decentralized’ trials, some remain concerned about how well they will actually ‘work’.  Decentralized trials are not what we are used to.  They do not operate the same way the traditional clinical trials we are accustomed to doing.  Describing how some of the procedures are going to work can be confusing, even to the site staff.

As noted in a November 2022 article “Fully Decentral Trials:  Aspirational Goal or Reality?”, some of the reasons for the hesitance include:

Concerns over lack of control

    • “How can I effectively treat the patients if I can’t see them?”
    • “I’m not using MY staff so how can I provide proper oversight?”
    • “How do I know the home healthcare nurses have been properly trained?”
    • “All of the assessments and data is being collected remotely?”
    • “But I’m not the one administering the drug…”

Challenges in maintaining data integrity

    • “Who’s entering the data?”
    • “Are they trained in GCP?”
    • “The patients are going to be responsible for that?”
    • “Can that DHT (Digital Health Technology) really collect that information accurately?”

Inability to complete more complex procedures outside of the traditional clinical setting

    • “How can we do that ‘decentrally’??
    • “Who is going to oversee that if it’s not being done in the office?”

There are certainly challenges with decentralized trials.  These can come from:

  • Staff and/or patients with limited experience with digital, remote, or AI technology
  • Detailed and highly variable state laws and regulations on the protection of patient information and confidentiality
  • Issues with prescribing and administering investigational product outside of the site
  • Ensuring consistency when executing protocols
  • How the data is handled and stored as well as how the data is being generated
  • Concerns with data privacy and confidentiality linked to the collection method and those collecting the data

Despite the concerns and challenges, there have been some real benefit to using decentralized and hybrid design trials (hybrid design trials are those where some aspects of the trial take place at the site while others are decentralized).:

    • Increased diversity in the trial population
    • Meeting patients where they are
  • One ‘partner’ vs. multiple sites
    • Sponsor pays one ‘decentralized partner’ rather than multiple sites with varying budgets
    • Dedicated data entry specialists ensured data consistency/integrity
  • Highly vulnerable populations don’t have to leave their home and travel to sites
    • Minimizes risk to elderly, critically ill, and medically vulnerable populations
    • Eliminates need for patient travel reimbursements

While not all trials or even trial procedures can be decentralized, there are efficiencies to be realized by investigating the potential of changing at least some aspects of clinical trials. Designing the trial to allow for decentralized visits and procedures must be done in the protocol design phase.  Careful evaluation of the technology and coordination with all stakeholders is critical.