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From oncology to infectious disease: How DCTs can optimize and accelerate diagnostic clinical trials

January 19, 2023

What is a diagnostic clinical trial? 

There are a variety of different tools, services, and tests that can be categorized as a diagnostics clinical trial. According to the National Cancer Institute, a diagnostic test is “a test used to help figure out what disease or condition a person has based on their signs and symptoms.” These can range from pregnancy tests, COVID rapid tests, STI tests, diagnostic tests for Lyme disease, strep throat tests, and many more. What is considered a diagnostic trial? Diagnostic clinical trials are the required evaluations of safety, functionality, effectiveness, etc., that are needed for approval and distribution of diagnostics issued by governing bodies such as the FDA. 

Some of these diagnostics are more invasive and require more in-depth testing than others.  At-home diagnostics, like a pregnancy test, are considered non-interventional and are, by nature, great fits for DCTs. However, clinical trials for diagnostic tests requiring complex procedures such as biopsies or blood draws for data collection do not necessarily have to take place in a prestigious research center. 

David Messina, Ph.D., COO of Cofactor Genomics and 20 yr veteran in computational biology and human genetics, authored an article on  Why the Future of Diagnostics Requires a New Approach to Trials. In this article, Dr. Messina states that a “[a decentralized]  approach to diagnostic trials, especially those that are non-interventional and may not require additional hospital visits, would allow patients to participate in a clinical trial no matter where they live, what their socioeconomic status is, and who their treating physician is. The future of diagnostic trials must be decentralized and supported by diagnostics CRO partners who can keep sites and protocols harmonized.”

Decentralizing diagnostic trials can, at first glance, require a lot of planning and coordination; this may be particularly true for a sponsor utilizing several vendors to execute their trial. However, if a sponsor can find a decentralized clinical trial vendor that can collectively offer the right services, they can reduce the challenges and barriers associated with decentralizing a diagnostic study. These remote diagnostics capabilities allow for greater patient access and expanded diversity among study participants within diagnostic health. 

Diagnostics CROs

The ability of a DCT vendor to offer diagnostics CRO services allows sponsors to have unified data collection and management, effective study start-up, and more all in one place.  DCT vendors with CRO services also give sponsors the freedom to conduct diagnostic studies in locations that are most convenient for patients. Dr. Messina notes that many barriers diagnostic studies face can “be reduced when a sponsor partners with a contract research organization (CRO) that is well-versed in running highly virtual trials. These diagnostics CROs are equipped with platforms to provide remote monitoring, electronic patient consenting, and electronic data capture.” Having the ability to range from being an oncology diagnostic CRO to a Covid rapid test CRO, for example, comes with experience and having purpose-built technology for the core elements of diagnostics research.

Diagnostic clinical trial software platform 

Why is the right software platform important for a diagnostic clinical trial? A diagnostics eClinical software platform should be comprehensive and patient-friendly. In order to run the necessary remote and virtual components of a diagnostic study, the software platform needs to offer ePRO, eCOA, eConsent,  telemedicine, and EDC/eSource, just to name a few. To learn more about all the capabilities that should come along with a diagnostics eClinical software platform, take a look at The “E’s” of eClinical Software: Understanding and defining technology elements of decentralized trials

Furthermore, Dr. Messina highlights that “a virtual trial platform also allows for sponsors to leverage direct-to-patient engagement. By extending trial sites beyond large academic centers to sites local to patients, we enable maximal diversity in recruitment, streamline participant engagement, and help ensure improvements to patient compliance. A diagnostics CRO will likely have preferred vendors for decentralized clinical trial software, and in some cases have their own DCT platform. “ 

Diagnostic clinical site model

Diagnostic sites are often specific to the type of diagnostic being studied. A DCT vendor with CRO services, a comprehensive software platform, and flexible site models can allow sponsors to utilize whatever site model is right for them. The top diagnostics CROs have site models and site networks that lend themselves to these types of decentralized clinical trials. For example, a study researching a diagnostic test for early cancer indication can be run from specific oncology sites where highly-qualified patients are likely to be. Another type of diagnostic site model could be fully remote, using a virtual site for an at-home, non-interventional Covid-19 rapid test. Most importantly, with a full-service DCT vendor, sponsors are given the flexibility and freedom to run their diagnostic trial where it is most convenient for the patient. . Ask your diagnostics CRO about which site models make sense for your study.

Diagnostic research design is a crucial element in constructing a trial strategy that’s right for your diagnostic research study. Whether is a diagnostic at-home study, or one that requires in-person site visits, the right DCT vendor can offer CRO services, site models, and software platforms that cater to your needs. 

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