Quest Diagnostics has built a series of collaborations with data providers that enable clients to link data sets with matched, de-identified data in order to understand the clinical trial patient journey. In this interview, David Freeman, general manager, Information Ventures, for Quest Diagnostics, discusses how the company uses its laboratory data to try to be an effective partner for pharmaceutical and biotechnology companies.

Q: Can you briefly describe Quest’s Clinical Insights and Clinical Trials Connect products, and how long they took from concept to product? Can you describe how each works in practice?

David Freeman: Most people I talk to in pharma and biotech know that Quest Diagnostics is a leader in laboratory diagnostic services. What they often don’t know is the depth of our experience and capabilities in data, analytics, and services across the development continuum. Beyond having over 48 billion clinical lab results in its database, Quest has 2,250 patient service centers, increasingly in retail locations, 20,000 mobile care professionals seeing patients in workplaces and the home. Quest provides services to half the country’s hospitals and physicians, roughly a third of the adult U.S. population every year. 

The Clinical Insights portfolio started in 2015 with dialogue between Quest data scientists and medical directors with researchers in pharma who were trying to understand large patterns in disease progression, diagnosis, and treatment. Those dialogues, which continue to this day, produce rich insights and customized at-scale data sets and analysis used for research and the planning of new therapeutic launches.

As our clients have realized how powerful clinical laboratory insights can be, they have asked us to enhance our offering in two important ways. The first centers around enabling the linkage between diagnostic laboratory insights with other data sets, and the second is to add services linked to patient recruitment in clinical trials. Recruitment offerings typically start with the sponsor or CRO sharing the inclusion and exclusion (I/E) criteria for a study. We use those criteria to provide three core services:

1. Site and investigator Identification and validation-based on the I/E criteria, do the clinical trial sites and investigators have an active patient pool that matches the study?

2. Physician outreach-to identify either potential principal investigators (those with 1572s filed) or physician referral networks, based on Quest relationships.

3. Patient outreach-Quest has an identified patient relationship and can outreach to patients to inquire if they are interested in learning about clinical trials opportunities.

Taken together, the Clinical Insights and Trials Connect capabilities support assessment, planning, and outreach in therapy development, from research all the way through to commercial launch.

Q: How much data cleaning, API building, or other tech involvement is required?

DF: Quest has been systematically investing in our data capabilities, connectivity, and partnerships for years. For example, Quest works with half of the country’s hospitals and physicians. To enable those relationships, Quest has over 650 active EMR (electronic medical record) interfaces that enable ubiquitous test ordering and high-availability results reporting.

For our pharma and public health customers, many of them have invested in clinical data sets that are particularly relevant to their disease focus. Quest has built a series of collaborations with data providers that enable these clients to link those data sets with matched, de-identified data in order to understand the patient journey, patterns in disease progression, acuity stratification, etc. For example, a therapy company may have a cardiovascular pipeline and has invested in an events database that contains stroke and heart attack data. Quest can leverage its laboratory data to perform analysis to match relevant biomarkers so that intervention opportunities and linkages between labs, medication history, claims and outcomes could be explored. Quest has invested in multiple de-ID collaborators so that our clients can choose from one of the six de-identified output formats, based on which “dataverse” they have previously invested in. A core principal for our data, analytics, and services business is that we do not lock our customers into only one data format or CRO.

Q: How does the physician get notified that a patient is a potential fit for a clinical trial?

DF: Quest Diagnostics is in a position of being able to contact a physician who may serve patients that are suitable for a trial. This contact may occur through one of our medical directors, for instance, and if the clinician is interested, more information is provided.

Effective patient recruitment has been a huge challenge for drug development. For every 100 patients that express interest in participating in a trial, 69% of those patients fail the pre-screen. That screen-failure rate is expensive, time-consuming, and frustrating to the site team and patients. Starting with known patients and matching their health history against study inclusion/exclusion criteria is a critical step in addressing this issue. 

Q: As industry moves into very specific targeted therapies, how do you see your services evolving?

DF: Today’s therapeutic landscape is very different than it was 20 years ago. Precision medicine, where new therapies are targeted to a patient’s specific genotype and phenotype, in essence, means that every new drug is a rare disease drug. This had led to amazing new therapeutic breakthroughs that also carry added complexity from a patient recruitment perspective.

With the largest diagnostic testing compendium and advanced companion diagnostics capability, Quest is extremely well positioned for the long run as an effective partner for pharma and biotech firms.

Q: What are your plans for further development and collaborations?

DF: There is a lot of innovation occurring in the clinical trials ecosystem and we are extremely proud to be part of that. Quest has a number of important partnerships and will continue to expand those in order to extend the range and value of our services.