Category: Physician identification

Mark your calendars—Parag More, Executive Director of Healthcare Analytics Solutions, will be presenting “How Lab Data Insights can Assist you in the Design and Execution of your Decentralized Trials” on September 29, 2021 during day 2 of DPharm. Click here to learn more about DPharm.

Lab data continues to play a critical role in the strategy, design, and execution of clinical trials. Patients’ diagnostic touchpoints at provider organizations and in community settings inherently provide the patient centricity that’s at the core of decentralized trials. Quest Diagnostics is playing an increasingly critical role in optimizing trials by using our proprietary lab data. The talk will explore the shifting dynamics of patient and provider engagement for decentralized trials and demonstrate how Quest Diagnostics is able to deploy engagement strategies for recruitment of clinically relevant participants. Discussion will also include how lab results and population insights help assess trial risks, analyze feasibility, and improve on the success metrics of decentralized trials.

DPHARM is the first event in the United States to question how we can disrupt the way clinical research gets done to reduce the burden to patients and physicians. DPHARM presented the first example of a decentralized clinical trial from Pfizer in 2011 and reports annually on the progress of flexible/decentralized trials with patient feedback.

Quest Clinical Trials Connect brings patient, physician, investigator, and other third-party data together to evaluate eligibility, enroll patients, and stay continually engaged through the clinical trial process.

Quest is proud to support DPharm as a corporate sponsor.

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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Recruiting for clinical trials has traditionally been an arduous and costly process, with likely candidates typically identified through hard-to-acquire physician referrals. Approximately 60% of referred patients fail at pre-screening, after 50% of the trial budget has been spent, and dropout rates aren’t much better, averaging around 30%, with most patients opting out either due to a lack of relevance or logistical constraints. 

To accelerate the recruitment process and support changing clinical trial models, investigators are increasingly turning to analytics to help facilitate the clinical trial recruitment process, including emerging hybrid and decentralized or “virtual” models. 

As a trusted partner, Quest brings experience and capabilities in data analytics to facilitate patient recruitment, leveraging a database of 58+ billion clinical lab results, 2,250 patient service centers — increasingly in retail locations – and 20,000 mobile care professionals seeing patients in the workplace and homes.

Leveraging lab databases and services enables critical linkage between diagnostic laboratory insights, other data sets, and patient services, informing recruitment offerings that typically start with the sponsor or CRO sharing inclusion and exclusion (I/E) criteria for a study. Based on the criteria, Quest provides a core patient outreach service through its Quest Trials Connect, which also includes site and investigator identification and validation, and physician outreach.

The patient outreach component of Quest Trials Connect deploys digital outreach campaigns to patient candidates on behalf of clients, measuring delivery, open, click-through, and pre-registration rates. If a campaign isn’t meeting expectations, Quest experts immediately ask why—helping clients dynamically change their investigator mix, geography, clinical criteria design, and outreach messages. 

Ultimately, the goal of any recruitment effort is to analyze populations of patients and predict who is going to enroll and be most likely to stay in the trial, both from a clinical standpoint and related to social determinants of health, which include demographics, psychographics, and other elements of the patient’s profile.

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By leveraging Quest’s relationship with half the country’s physicians and hospitals, a leading pharmaceutical company was able to identify over 1,000 additional physicians to approach for clinical trial participation or physician referral to study sites. This could allow for a higher rate of patient enrollment and improved cost-effectiveness—streamlining clinical trial operations to help bring new medicines to market in a timely fashion.