Category: Clinical Trials – Early Phase

Leveraging lab data to operationalize clinical trials can significantly streamline the development and recruitment process, not to mention lowering overall costs and accelerating time-to-market for new drugs and treatments. What’s that worth? Considering that every day of a patent life is a million dollar win for pharma, quite a lot.

Using lab data, combined with other data sources, also increases screening accuracy, helping to identify candidates most likely to clear trial inclusion/exclusion criteria. Since 60% of patients who express interest in a clinical trial ultimately fail to qualify, this is a big efficiency gain, especially balanced against the cost of prescreening, where 50% of the budget has already been committed to patient outreach.

What about the quality of clinical lab data when it comes to decision-making? When lab data is combined with claims, it gives researchers a window into diagnostic history, as well as patient procedures. Lab data is also the common language of physicians and, given the longitudinal view, enables researchers to see how values change, both independently and in concert with other values.

Indeed, 70% of clinical decisions are made, at least in part, on clinical lab data results.

When relying on lab data, expertise and a robust database are of critical importance. Quest is a trusted partner with experience and capabilities in data, analytics, and services across the trial development continuum, leveraging a database with more than 58+ billion clinical lab results in our database, as well as 2,250 patient service centers.

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With rapid digital transformation occurring in healthcare today, it is understandable that the Food and Drug Administration (FDA) is calling for new, decentralized clinical trial models, both to improve the efficiency and impact of studies, and to reduce overall costs. Quest supports this position, acknowledging that we are in a transformational time, not only related to therapeutics but also to today’s data and computing environment.  

As demonstrated by the accelerated development of COVID-19 vaccines, we now have the digital capabilities and know-how to scope, define, recruit, test, and bring to market broad-spectrum medications for large populations, as well as biologics and cell-based therapies, putting patients at the center of the process.  

Instead of just establishing more sites and recruiting more patients, which requires both enormous budgets and long cycle times, the opportunity now exists to connect to the right patients, as well as care teams, labs, health plans, and the pharma and clinical trial industry overall, catalyzing a different approach. Downstream, the benefits to pharma are enormous, as every day of patent life is worth an estimated million dollars.

Shifting the focus

While today’s medicines are more complex, many clinical trials are still conducted for the broad population versus the focused populations they are intended to benefit. This approach is both inefficient and expensive, with 60% of patients who express interest in a trial failing at prescreen. Given that approximately 50% of a trial’s budget has already been spent for patient outreach prior to prescreening, this underscores the inefficiency of the traditional approach.  

Additionally, only two percent of physicians in the country participate in clinical trials, with half one-and-done. Most never participate again because they consider the process too cumbersome and difficult to navigate.

Leveraging the power of analytics

To cut through this inertia requires an infrastructure built around data analytics that adheres to privacy and regulatory requirements. At Quest, we recognize the need to standardize and normalize data, pulling it together into a secure cloud and translating it into a de-identified, secure, linkable format. This platform unlocks the power of lab data, especially when linked to other kinds of information, such as claims, diagnostic history, procedures, etc. 

Related to clinical trials, analytics also supports and enables more complex and precise inclusion/exclusion criteria, as well as prior diagnostic and therapeutic exposure. In this spirit, it is also important to partner with other data suppliers to create a robust infrastructure that meets these demands. 

At Quest, our robust database, which includes 58+ billion clinical lab results from 2,250 Patient Service Centers, can be parsed to reflect the size of targeted populations, the kinds of physicians participating patients see, how their disease has evolved over time, the impact of one therapeutic over another on underlying biology, etc. All of this is served up through cohort analytics, enabling researchers to garner a rich depth of insights to inform their efforts. 

Today, Pharma and CROs can access this level of data through our Quest self-service platform via a subscription service. Quest data can also be leveraged to help with digital outreach campaigns. 

In a very real sense, it is all about looking at a population of patients and being able to predict who is going to enroll and who is most likely to stay in the trial, both from a clinical standpoint and related to social determinants of health, which factor in demographics, psychographics and other elements of the patient’s profile.

In this context, it is important for investigators to think about the therapeutic design and the patient population they are reaching out to when deciding whether to go with a traditional anchor site trial, a hybrid model with sub-PIs, or a direct-to-patient/virtual trial. Understanding how patient populations or therapies fit these scenarios is key to the trial’s success.

Don’t underestimate the power of convenience, relevance

Ultimately, some of the biggest justifications for a decentralized clinical trial model are convenience and relevance. People want trials that are both relevant to them personally and close to home, otherwise trials wouldn’t have as much as a 30% dropout rate. The days of moving the patient to the PI or a clinical trial institute are largely over.

In a decentralized model, any number of touchpoints can become part of the network for a trial, putting more and more capabilities into service centers. In these environments, health care professionals can also help identify and pre-screen patients as they do standard-of-care visits. It is only when a patient has a more invasive, complex issue that they need to go to a hospital to participate in an onsite clinical trial. 

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Most people have heard of clinical trials but only understand how they work in vague terms and often associate them with negative stereotypes. There is a long and dark history surrounding clinical trials, but recent efforts and regulations have made participating in clinical trials safe while giving patients the opportunity to try cutting-edge treatments. At Quest, the Specialty Clinical Trials BioPharma team supports testing for phase I-III clinical trials every day.

A novel drug can take up to 20 years and a billion dollars to get approved by the FDA. The process starts with preclinical studies where a novel drug is tested on animals to see if the researchers’ theory works in a living being. If it works as expected, testing of the drug moves into phase I studies which are generally very small groups of healthy volunteers or, in cases where the drug is already known to be safe in people, patients with a different disease who have not responded to other therapies. These are called safety trials and the goal is to find the optimal dose for the new drug with the fewest side effects. Phase II studies are done on slightly larger groups, and the goal is to determine if the drug actually works for the disease, while continuing to understand its safety implications. If the drug passes this stage then phase III studies are started. These are generally large studies that span several years and look to determine if the new drug works better than the existing standard of care treatments. If a drug passes this phase, it has beaten the odds and is the 1 in 5,000 to actually make it through this process and onto the market.

The goal of all of these trials is to progress research and knowledge, while offering new and effective treatment options to patients coping with a devastating diagnosis. The Sponsors of these trials also often help pay for medical and travel costs for patients enrolled in their trial, and offer them the opportunity to use their burden as a way to help other people in the future.

Quest offers the expertise and specialized testing that is required to identify and enroll subjects into these clinical trials, monitor a subject’s disease and overall health while they are on trial, and perform exploratory testing to support future research. Quest also provides phlebotomy services at our Patient Service Centers and at patients’ homes to make participating in these trials easier. Quest supports so much important work, and part of this includes giving patients hope for a little more time, the opportunity to advance research, and to simply have a better quality of life over their last days.

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