MedCity Influencers, Devices & Diagnostics, BioPharma

Leading Clinical Trial Recruitment Strategies Center Around Real-World Data

By allowing study teams to design and conduct more inclusive and/or relevant studies, real-world data can enhance the standard of care and ultimately improve patient outcomes.

Last year, Walmart expanded its reach into real-world patient data through its entry into clinical trial recruitment. The retailer is joining the growing movement to break down health data silos and offer a solution to barriers that have plagued the industry for years—chief among them—poor recruitment, which is often cited as the primary reason for clinical trial failure. With pharmacy chains Walgreens and CVS Health also launching clinical trial service businesses in recent months, the three retail giants stand to gain access to significant patient data including electronic health records (EHRs), lab results, retail pharmacy data, and insurance claims. The data can provide valuable insights that lead to more informed and inclusive clinical trial design.

Real-world data insights help trial sponsors better understand disease states, comorbidities, biomarkers, and patient treatment journeys—important information that allows research teams to define patient pools more rapidly and accurately. This can be reflected in different ways: When sponsors design studies with overly restrictive inclusion criteria, they may struggle to find enough patients to participate, leading to prolonged recruitment or a need to amend their protocols. For example, oncology trials often have restrictive cut-offs for lab values such as bilirubin, albumin and neutrophils. However, a recent study found that relaxing these requirements would dramatically increase the number of eligible patients, while having little to no impact on efficacy and safety data.

At the other end of the spectrum, when recruitment criteria are too broad, it may be easier to find participants, but cohorts may have certain comorbidities that increase the likelihood of withdrawal from the study. In other cases, it may be beneficial to exclude certain populations that have exhibited a negative correlation with outcomes that might reduce efficacy of the drug to be tested.

Today’s technology provides sponsors and CROs with access to anonymized and pseudo-anonymized data that allows them to interrogate patient populations while maintaining patient privacy to build inclusion/exclusion criteria intelligently.

Walmart’s approach will likely be to define an optimized cohort and use data to identify and invite patients who might be good candidates for a specific study. The retailer also plans to use its access to underserved communities and rural areas to help expand and diversify clinical research participant pools. For example, a study team investigating a new treatment for hypertension might approach a major retail pharmacy to offer participation to patients currently taking a standard of care ACE inhibitor. Real-world data can act as a one-way mirror: Study teams can see that a certain number of patients could benefit from a trial, and those patients can see that a trial is open to them. Meanwhile, strict parameters around the usage of real-world data preserve the ethical and legal boundaries necessary for patient privacy and data quality.

Visibility into clinical trial availability can be invaluable to patients, particularly those with rare diseases who often struggle to find clinical trials that are right for them. A key barrier to participation in research is “lacking awareness of opportunities,” according to a systematic review of studies that reported the perspective of patients who accepted or declined to participate in clinical trials. By partnering with healthcare providers who have access to real-world data, study teams give patients the opportunity to speak with their physicians about trials, allowing them to make informed decisions about their participation.

As with any technology advancement, there are challenges associated with using real-world data. Study teams and healthcare providers must continue to prioritize data privacy, an area that will likely draw more attention from regulatory agencies in the coming years. In addition, study teams must grapple with the possibility of unseen bias, making it essential that they carefully interrogate the data for skews. For instance, certain studies in women’s health could be prone to socioeconomic bias by virtue of the datasets that skew towards higher-income women more likely to receive routine gynecology care.

Despite these challenges, real-world data has strong potential to enhance clinical research. These developments in the life sciences industry hold tremendous promise for patients, providers and sponsors alike. By allowing study teams to design and conduct more inclusive and/or relevant studies, real-world data can enhance the standard of care and ultimately improve patient outcomes.

Photo: elenabs, Getty Images


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Ivan Jarry

Since taking the helm at ObvioHealth, CEO and co-founder Ivan Jarry has grown the company 13-fold. Ivan leveraged advances in digital technology to tackle the inefficiencies in clinical research, designing one of the first patient-centric apps for decentralized clinical trials. Since then, he has put agile teams and processes in place to quickly scale the business.

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