Diagnostics CROs, diagnostic studies, and diagnostic research: Navigating the basic vocabulary in diagnostics clinical trials

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The healthcare industry has witnessed a significant evolution in the realm of diagnostics, primarily due to advancements in medical technology and research. Diagnostic clinical trials or diagnostic studies are instrumental in this evolution, paving the way for accurate illness detection, treatment, and prevention. They are key to the development of efficient diagnostic tools for various medical conditions. This article delves into the world of diagnostic clinical trials, focusing on their importance, types, and the role of diagnostics clinical research organizations (CROs) in the process.

Understanding Diagnostic Clinical Trials

Diagnostic clinical trials are designed to evaluate the effectiveness, safety, and accuracy of various diagnostic methods for specific symptoms or medical conditions. Before any diagnostic tool can be made available for public use, it must undergo rigorous testing and research. This testing and research phase is what we refer to as a diagnostic clinical trial.

Diagnostic Study Examples

One notable example of a diagnostic study is the COVID-19 diagnostic study conducted by Clip Health. They used one of Curebase's flexible site models to test 383 patients in two months, leading to the FDA EUA approval of Clip's COVID-19 diagnostic test. However, not all diagnostic trials can be expedited. Certain complex trials, such as oncology diagnostics, require a more elaborate trial design and possibly long-term follow-up.

Diagnostic Tests for COVID-19

COVID-19 diagnostic tests are designed to ascertain if an individual is currently infected with the SARS-CoV-2 virus. The test types available include PCR (polymerase chain reaction) tests and antigen tests.

• PCR tests are considered the gold standard for COVID-19 diagnosis. They use a sample from the patient's nose or throat to detect the SARS-CoV-2 virus. Despite their accuracy, the results take longer to process.
• Antigen tests are rapid diagnostic tests that identify specific proteins on the virus surface. They can produce results in less than an hour and are relatively inexpensive. However, they may yield a higher rate of false negatives.

Choosing between the two tests depends on the individual's symptoms, community transmission level, and test availability. It's important to note that a negative test result does not necessarily rule out COVID-19, especially for those recently exposed or in their incubation period.

Oncology Diagnostics

Oncology diagnostics are leveraged to identify cancer in individuals using various tests and examinations, including laboratory tests, imaging studies, and biopsies. These tests help determine the type and stage of cancer, consequently informing the best treatment plan.

Oncology Diagnostic Tests

• Blood tests: These include complete blood counts (CBC) and tumor markers (proteins that are often elevated in individuals with specific cancer types).
• Imaging tests: Examples are X-rays, CT scans, MRIs, ultrasounds, and PET scans.
• Biopsy: A small tissue sample is removed and examined under a microscope to confirm the presence of cancer cells.

Regular cancer screening is recommended for high-risk individuals as early cancer detection and diagnosis are key to successful treatment.

Liquid Biopsy Diagnostics

Liquid biopsy diagnostics are non-invasive diagnostic tests that use a sample of blood, urine, or other body fluids to detect and monitor cancer. These tests are also known as "circulating biomarker" tests.

Types of Liquid Biopsy Diagnostics

• Circulating tumor DNA (ctDNA) tests: These tests detect small DNA fragments released by cancer cells into the bloodstream.
• Circulating tumor cell (CTC) tests: These tests detect and enumerate cells that have detached from a primary tumor and are circulating in the bloodstream.
• Exosome tests: These tests detect and analyze small extracellular vesicles released by cancer cells.
• Protein biomarkers: Examples include CA-125 for ovarian cancer, PSA for prostate cancer, and CEA for colorectal cancer.

Liquid biopsy tests hold several advantages over traditional tissue biopsy methods. They are non-invasive, can be repeated frequently, can detect cancer at early stages, and can be used to monitor response to treatment. However, these tests are still in the early stages of development, and more research is needed to fully realize their clinical utility.

In-Vitro Diagnostics (IVD)

In-vitro diagnostics (IVD) are medical tests performed outside the body, typically in laboratory settings. They are used to detect and diagnose diseases, monitor treatment progress, and assess overall health.

Types of IVD Tests

• Blood tests: These include complete blood count (CBC) and serum chemistry tests.
• Microbiology tests: Examples are bacterial and viral cultures.
• Immunoassays: These include enzyme-linked immunosorbent assays (ELISAs) and rapid diagnostic tests (RDTs).
• Molecular diagnostics: These involve polymerase chain reaction (PCR) and next-generation sequencing (NGS).
• Histology and cytology tests: Examples include Pap smear and biopsy.

The results of IVD tests are essential for accurate and timely diagnoses, ultimately improving patient outcomes. It's worth noting that IVD tests are subject to national and international regulations to ensure accuracy, reliability, and patient safety.

Home-Based and Remote Diagnostics

Home-based or remote diagnostics are diagnostic tests that patients can self-administer in non-clinical settings. Examples include at-home pregnancy tests and rapid at-home strep tests. While these tests are easily accessible and convenient for patients, they require additional research to ensure safety and effectiveness. However, technology, such as software platforms, and services like mobile nursing or phlebotomy can facilitate remote diagnostics and make them more patient-friendly.

Diagnostics Clinical Research Organization (CRO)

A diagnostics CRO oversees day-to-day operations of diagnostic clinical research studies from start to finish. As studies become increasingly decentralized, diagnostics CROs offer technology-driven services beyond traditional offerings to reach more patients, collect cleaner data, and tailor to the unique needs of individual studies.

Diagnostic CRO Services

Diagnostic CRO services can vary based on the study type, but they typically include diagnostic research design, planning, and execution, clinical data management, project management, and trial monitoring. By working with sponsors, diagnostics CROs can design studies that properly define essential roles and responsibilities.

In conclusion, diagnostic clinical trials play a significant role in healthcare, driving the development of accurate and efficient diagnostic tools. The role of diagnostics CROs in the process cannot be understated, making it possible to accelerate diagnostics clinical trials and companion diagnostics clinical trials through their various services. The innovation in diagnostic clinical trial phases is leading to a brighter future for diagnostics in healthcare.

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