No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies.
While the test results are clearly valuable to the requesting physician to inform diagnostic decisions, sponsors can also leverage this information to support patient recruitment in an increasingly competitive space. We recently evaluated how de-identified patient data from these common tests run by LabCorp can support sponsors' clinical trials in rheumatoid arthritis.
Tapping into a rich resource
When tests are ordered through LabCorp, the results are stored in a secure database along with supporting metadata. The additional data includes the ICD-10 codes for the patient, physical testing location, healthcare professional specialty, as well as general information such as age, sex, co-morbidities and number of visits to the physician. With today's analytical technologies and informatics capabilities, many new insights can be collected to improve forecasting and clinical development planning.
Adjusting inclusion/exclusion criteria in real-time
Protocol design is one area that benefits from access to this trove of relevant test results. Sponsors seeking to optimize their study design can evaluate the feasibility of their protocol's inclusion/exclusion criteria, a practice that is valuable before protocol submission and even during a study to address in-flight issues.
Querying the LabCorp database by ICD-10 codes for these two common RA tests, ESR and CRP, the desired values can be set for each test result along with choices in patient demographics. A baseline result is returned with the number of eligible participants and summary statistics of the selected lab parameters. This information can then be compared to different scenarios, such as directly measuring the effect of increasing the CRP levels on the number of eligible patients, or measuring the change in variability of ESR when the age range is increased.
Using values calculated from real-world evidence - not estimates or best guesses - helps sponsors quantify their recruitment timelines with higher accuracy, assess the true impact of eligibility criteria and decrease screen failure rates.
Locating eligible patient populations
Another crucial factor in optimizing a clinical trial is determining which sites are most appropriate for their study. The LabCorp data can be transformed into a heat map of eligible patient populations (clusters) based on any combination of patient diagnosis codes, test results, test ordering patterns or patient-level progression of a disease state. Overlapping patient clusters and physicians can then be identified across the U.S. This information can be supplemented by leveraging the Covance Xcellerate® database, which tracks investigator performance, to pinpoint the best sites to support the study.
Geographic patient and physician information can also highlight gaps in coverage. For example, the heat map of RA patients from LabCorp may indicate that a large patient population isn't served by a known investigator. In that case, the sponsor may choose to engage a new investigator site or establish a referral relationship with the physicians who are frequently ordering RA-related tests or see RA patients that may screen into their study.
Opting-in to clinical trials
Beyond gathering and mining patient information, LabCorp's online patient portal has added an option for people to opt-in and consent to receive information about clinical studies. In a very short time frame, we've amassed over 120,000 people who have expressed interest in participating in applicable clinical studies. Sponsors can also leverage this information to boost their recruiting strategy and potentially locate new, engaged patient populations to support their recruitment efforts.
Learn more about how LabCorp's database of 13 billion test results can optimize your protocol and accelerate patient recruitment at Covance.com