Four Ways Lab Data Can Enhance Clinical Research
A recent survey by the Deloitte Center for Health Solutions of biopharma executives and other industry leaders found that 90% of respondents are attempting to leverage real-world evidence, derived from real-world data (RWD), in their product life cycle.1 While many may understand the value of RWD from medical and pharmacy claims or electronic medical records (EMR), even more benefits can be derived from lab data. As leaders in the exchange of RWD and one of the only companies to have access to lab results from both Labcorp and Quest Diagnostics, we have compiled the top four benefits that lab data can add to your clinical research:
1. Unlock the Ideal Clinical Trial Site Selection
When designing clinical trials, lab data can provide additional insights into site selection and potential study participants, which can increase efficiencies and accelerate the trial. By exploring lab data, you can isolate physician offices or potential investigator sites where patients of interest with a key laboratory result, diagnosis or biomarker are being treated. This is in contrast to medical claims or EMR data that may only include ordered tests without results, while EMR data alone rarely includes physician identifiers.
HealthVerity is working with a major pharmaceutical company that is studying treatments and vaccinations for RSV. The client is actively utilizing near real-time lab results to conduct disease surveillance. This enables the client to identify ideal clinical trial sites and healthcare providers across the U.S. that could participate in upcoming clinical trials based on disease spread. Additionally, the lab data offers insights into the epidemiology of the condition, how RSV may interact with COVID and other seasonal concerns.
2. Reveal Optimal Participants
It is critical to identify optimal patients, both for participation in clinical trials and for RWD research. Lab results provide quantitative indicators that the patients meet your specific criteria. While some researchers have traditionally chosen to use EMR data to search for patients, the data in EMRs is limited to what the healthcare provider (HCP) inputs, such as with lab results that are often sent to HCPs in a PDF format that is attached to the electronic medical record and cannot be shared in a HIPAA-compliant manner. Additionally, as mentioned, EMRs rarely include physician identifiers, making discovery of de-identified patients in EMRs more difficult.
Using lab data is particularly useful when identifying patients with rare diseases where there is not a specific diagnosis code or the patient is misdiagnosed. In these instances, a genetic biomarker, indicated in a lab test, can be used to classify someone as having a rare disease. For instance, hypophosphatasia (HPP), a rare genetic disorder that causes weakness in the teeth and bones due to impaired mineralization brought on by changes in the ALPL gene, is diagnosed with an alkaline phosphatase (ALP) lab test.2
3. See Beyond the Trial Investigator’s View
Working within the scope of the clinical trial, investigators may only have a limited view into the health of participants. Additionally, the investigator has to rely on the patient to share any potential concerns, which the patient may believe are unrelated. Real-world lab data can provide a view into the care that patients may be receiving outside of the trial, the status of comorbid conditions or potential safety concerns.
Lab data can be particularly beneficial in tracking the effects of investigational therapies on comorbid conditions. For example, if a person with diabetes is participating in a clinical trial for a hypertension medication, lab data might reveal a sudden increase in A1C levels. This is a potential safety concern that sponsors would want to be aware of and to investigate further.
4. Understand Synthetic Control Arm Results in Near Real-Time
When using a synthetic control arm, researchers need to know the status of the patients as the study is progressing, not what happened months ago. Lab data is available in near real-time with only days to a week lag time, whereas EMR data is refreshed monthly and payer data may lag 90-120 days or even longer.
The COVID-19 pandemic epitomized the need to accelerate clinical research in order to better understand the virus and develop vaccine and treatment options. HealthVerity delivered a comprehensive national COVID patient cohort of RWD to Janssen, enabling their teams to garner insights and to conduct synthetic clinical studies in support of their vaccine approval efforts.
HealthVerity also de-identified trial participants, assigning a unique but persistent HVID in lieu of personally identifiable information (PII), allowing Janssen to augment clinical trial data with RWD in a privacy-protected manner and to observe the progress of the disease over time.
Lab data played a critical role in these efforts, providing not only timely COVID variant information, but also enabling Janssen to monitor key diagnostic results for patient populations at the greatest risk. The near real-time nature of lab results allowed Janssen and other COVID-19 vaccine manufacturers to quickly assess the efficacy of a vaccine across tens of millions of people while clinical trial enrollment numbered tens of thousands of people.
HealthVerity offers the nation’s largest healthcare and consumer data ecosystem that, as mentioned, includes lab data from both Quest Diagnostics and Labcorp, representing approximately 60% of the total outpatient laboratory market. Several other laboratories also partner with HealthVerity, such as genomic and pathology labs. The HealthVerity IPGE platform, an integrated technology and RWD infrastructure built on the foundational elements of Identity, Privacy, Governance and Exchange, enables the discovery of research-ready RWD, including this valuable lab data, allowing researchers to build more comprehensive and accurate patient journeys and power best in-class analytics and applications with flexibility and ease. Click here to request a demo to see what lab data the HealthVerity IPGE platform can connect you with.
1 Morgan, J., Feghali, K., Change, C. and Miranda, W. (2022).
Real-world evidence’s evolution into a true end-to-end capability. Deloitte Insights.
2 NORD. Hypophosphatasia.