Patient Engagement

Chances are you’re already doing decentralized clinical trials

DCTs improve effectiveness and efficiency while emphasizing direct-to-patient interaction.

If you work in the clinical research industry, you have likely heard the term decentralized clinical trial, abbreviated DCT. While our industry is famous for creating new acronyms, these terms do not always clearly convey their true meaning. After all, aren’t all clinical trials, by definition, decentralized given that they are traditionally carried out across distributed locations and sites?

In recent years, ‘decentralization of clinical trials’ has come to refer to the increasing virtualization of clinical research. It relies on well-established methods for virtual conduct such as ePRO, eConsent, and eSource, and encompasses newer approaches such as digital health and direct connection to electronic health record (EHR) systems.

So, consider your study a DCT if you’re doing some of the following:

  • Consenting patients electronically, via their smartphone, PC, or other device(s),
  • Sending healthcare professionals to meet patients at their home for services such as phlebotomy, sample collection, or treatment administration.
  • Connecting to the patient’s EHR to auto-populate the trial database,
  • Enabling patients to interface with clinicians via a televisit or video conference,
  • Having patients complete assessments such as questionnaires and diaries electronically from home,
  • Shipping investigational products directly to study participants, and
  • Instrumenting participants with connected devices to measure their health digitally.

DCTs deemphasize the traditional role of the clinical trial site in favor of more direct-to-participant interaction (sometimes, ironically, via a centralized ‘virtual site’). DCTs are possible today thanks to advances in web technology, clinical grade sensory devices, and data interchange standards. The COVID-19 pandemic, in particular, accelerated DCTs, as many clinical sites were simply unable to see patients in person.

Regulators and Patients Support Decentralized Clinical Trials

DCT approaches have the support of regulators. The FDA, for example, has issued draft guidance on DCTs, and has long standing, specific guidance on topics such as electronic informed consent.

“The FDA has long considered the benefits of decentralized clinical trials. Advancements in digital health technologies and the COVID-19 pandemic—when in-person visits were limited or unavailable for many trial participants—have accelerated the broader adoption of these activities. As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”

Those are the words of FDA Commissioner Robert Califf in a news release announcing additional draft guidance on decentralized clinical trials in May of this year. The draft guidance has recommendations and guidance on specific topics for DCT implementation, including:

  • DCT Design,
  • Remote Clinical Trial Visits and Clinical Trial-Related Activities,
  • Digital Health Technologies,
  • Roles and Responsibilities,
  • Informed Consent and Institutional Review Board Oversight,
  • Investigational Products in a DCT,
  • Packaging and Shipping of Investigational Products,
  • Safety Monitoring Plan and
  • Software Used in Conducting DCTs

I took particular note and comfort in one of the FDA’s software recommendations, which is:

Software programs that are used to produce and process trial records required by the 523 FD&C Act and FDA regulations are subject to 21 CFR part 11. These programs must ensure data reliability, security, privacy, and confidentiality.

As FDA Commissioner Califf wrote, “…decentralized clinical trials may enhance convenience for trial participants.” Since DCTs offer a higher level of convenience for participants and are less constrained by geography, this approach can help make recruiting trial participants easier.

Clinical trials often take a hybrid approach to decentralization. Making an entire trial completely virtual is often not practical, but there are nearly always parts of any trial that can benefit from virtualization.

While DCTs improve participant convenience and patient diversity, there are challenges too. DCTs produce different streams of data which can be difficult to organize. Software can help with this. For example, as a decentralized clinical trials platform, OpenClinica:

  • Coordinates study activities across stakeholders,
  • Delivers a frictionless experience for patients who want to participate in your trial,
  • Automates reminders and notifications via text message and email,
  • Auto-populates case reports forms with pre-existing data from  patient EHRs,
  • Makes it easy to incorporate data from digital health devices, and
  • Allows you to keep all your data in one place.

OpenClinica’s decentralized clinical trials toolkit includes:

  • OpenClinica Consent™, a complete electronic informed consent solution for improved efficiency, access and patient engagement in clinical trials
  • OpenClinica ParticipateTM electronic patient reported outcomes (ePRO) and
  • OpenClinica UniteTM, an award-winning EHR to EDC integration technology that automates source data acquisition from EHRs and EMRs to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale.

Allow us to show you the exciting ways we are able to make research more effective and efficient. The result is better data, faster!

To start a free trial of OpenClinica’s platform for decentralized clinical trials, click here: https://www.openclinica.com/request-a-free-trial/

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