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

What are diagnostics?

Diagnostics refers to the process of identifying the cause of a specific medical condition or symptom through the use of various tests and examinations. This can include laboratory tests, imaging studies, and physical examinations. The results of these tests and examinations are used to make a diagnosis, which is a determination of the specific medical condition that is causing the symptoms. Diagnostics can take many forms including rapid tests that can be used at home for simple illnesses like COVID. Other diagnostics may take place at a central laboratory for processing and determining more complex conditions like biomarkers for cancer as seen in liquid biopsies. 

What are diagnostic studies?

Diagnostic clinical trials or diagnostic studies are trials designed to specifically study factors such as effectiveness, safety, accuracy, etc., in patients with specific symptoms or indications of a particular diagnosis. When it comes to answering ‘what are diagnostic studies?’ the answers can range across a multitude of indications however, diagnostic tools used for healthcare and medical decisions must go through rigorous testing and research before these diagnostic tools are made accessible to the public. Diagnostic research studies are simply the testing and research made necessary by the FDA  for diagnostic tools and products. 

What are examples of diagnostic studies?

The expedited trial planning, execution, and completion of Clip Health’s COVID-19 diagnostic study is a strong example of innovative health diagnostic studies. Clip Health used one of Curebase’s flexible site models to test 383 patients for COVID-19 within two months. Clip’s COVID diagnostic test received FDA EUA in 3 months' time by recruiting patients to their diagnostic study using pre-existing COVID testing sites where patients were already located. However, accelerated diagnostics clinical trials aren’t always the right approach, some oncology diagnostics require a more complex trial design with long-term follow up. 

What is a COVID diagnostic test?

A COVID-19 diagnostic test is a test that is used to determine whether an individual is currently infected with the SARS-CoV-2 virus, which causes COVID-19. There are several types of COVID-19 diagnostic tests that are currently available, including PCR tests and antigen tests.

PCR (polymerase chain reaction) test is a laboratory-based test that uses a small sample of the patient's nose or throat to detect the presence of the SARS-CoV-2 virus. It is considered the most accurate diagnostic test for COVID-19, but it takes longer to get the results.

Antigen tests are rapid diagnostic tests that detect specific proteins on the surface of the virus. These tests are relatively inexpensive and can provide results in less than an hour, but they are less sensitive than PCR tests and may have a higher rate of false negatives.

Both types of tests have different advantages and disadvantages, and the choice of which test to use depends on factors such as the individual's symptoms, the level of community transmission, and the availability of tests. It is important to note that a negative test result doesn't rule out the possibility of an individual having COVID-19, especially if they have a recent exposure or if they are in the incubation period.

What are oncology diagnostics?

Oncology diagnostics refers to the process of identifying cancer in an individual through the use of various tests and examinations. This can include laboratory tests, imaging studies, and biopsies. The results of these tests and examinations are used to make a diagnosis of cancer and to determine the type and stage of cancer.

Some examples of oncology diagnostic tests include:

Blood tests: such as complete blood count (CBC) and tumor markers (proteins in the blood that are often elevated in people with certain types of cancer)

Imaging tests: such as X-ray, CT scan, MRI, ultrasound, and PET scan

Biopsy: which is the removal of a small sample of tissue to be examined under a microscope to confirm the presence of cancer cells.

The combination of these tests and examinations helps the oncologist to determine the best treatment plan for the individual with cancer.

It is important to note that early detection and diagnosis of cancer are crucial for the success of treatment, and regular cancer screening is recommended for people at high risk for certain types of cancer.

What are liquid biopsy diagnostics?

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

Some examples of liquid biopsy diagnostics include:

Circulating tumor DNA (ctDNA) tests: These tests detect small fragments of DNA that are released by cancer cells into the bloodstream. ctDNA tests can be used to detect the presence of cancer, monitor the progression of the disease, and track the response to treatment.

Circulating tumor cell (CTC) tests: These tests detect and enumerate cells that have detached from a primary tumor and are circulating in the bloodstream. CTCs can be used to detect and monitor the progression of cancer.

Exosome tests: These tests detect and analyze small extracellular vesicles that are released by cancer cells. Exosomes can be used to detect and monitor the progression of cancer.

Protein biomarkers: such as CA-125 for ovarian cancer, PSA for prostate cancer, and CEA for colorectal cancer.

Liquid biopsy tests have many advantages over traditional tissue biopsy methods because they are non-invasive, they can be repeated frequently, they can detect the presence of cancer at an early stage, and they can be used to monitor the response to treatment. However, it is important to note that liquid biopsy tests are still in the early stages of development and more research is needed to fully understand their clinical utility.

What are in-vitro diagnostics (IVD)?

In-vitro diagnostics (IVD) is a type of medical test that is performed outside of the body, typically in a laboratory setting. These tests are used to detect and diagnose diseases, monitor treatment progress, and assess the overall health of an individual. They are also known as "lab-based" or "off-body" diagnostics.

IVD tests can include a wide range of tests such as:

Blood tests: such as complete blood count (CBC) and serum chemistry tests

Microbiology tests: such as bacterial and viral culture

Immunoassays: such as enzyme-linked immunosorbent assays (ELISAs) and rapid diagnostic tests (RDTs)

Molecular diagnostics: such as polymerase chain reaction (PCR) and next-generation sequencing (NGS)

Histology and cytology tests: such as Pap smear and biopsy

IVD tests are performed on samples such as blood, urine, saliva, and tissue, and are used to diagnose and monitor a wide range of conditions, including infectious diseases, cancer, and genetic disorders. IVD tests are an important tool in healthcare, allowing doctors to make accurate and timely diagnoses, which in turn can help to improve patient outcomes.

It is important to note that IVD tests are regulated by national and international regulations, ensuring that the test results are accurate and reliable and that the tests are safe for patients.

What are home-based diagnostics or remote diagnostics? 

Remote diagnostics or at home diagnostics are diagnostic tests, which can often be self-administered, that can be taken by patients in a non-clinical setting. Remote diagnostics do not require in-person administration by a healthcare provider and can therefore be taken in a setting desired by patients. An example of remote diagnostics would be an at-home pregnancy test, a rapid at-home strep test. Diagnostics at home may need additional research in real-world settings to ensure they are safe and effective for patients to use at home by themselves. 

Although these particular diagnostic tests are easily made accessible to patients to take in their homes, there are ways to administer other diagnostic tests in a remote manner that does not burden a patient with travel requirements. This is why clinical trials for diagnostic tests can be decentralized by using flexible virtual site models, diagnostic CROs experienced in DCTs, mobile nursing/phlebotomy if necessary, and technology such as a software platform to run and track the diagnostic trial from start to finish. 

Diagnostic CRO:

A diagnostics CRO or contract research organization traditionally oversees all or most day-to-day operations of diagnostics clinical research studies from start to finish. As studies become more decentralized by nature, the right diagnostics CRO can offer technology-driven services beyond traditional offerings to reach more patients, collect cleaner data, and tailor to the unique needs of an individual study.

Diagnostic CRO services: 

Diagnostic CRO services can include diagnostic research design, planning, and execution, clinical data management, project management, trial monitoring, and more. Diagnostics CRO services can look different for different types of studies. Each study is unique in its own way; diagnostics CROs can work with sponsors to design a study that properly scopes essential roles and responsibilities.