Advancing New Health Care Paradigms in Pharma

The modernization of clinical trials accelerated after Congress enacted the 21st Century Cures Act into law in 2016. Its purpose: to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

A potential silver lining to the global pandemic was proving the feasibility of more efficient and cost-effective methods to conduct clinical trials and provide patient care. Innovation adoption occurred at a speed never seen before, changing how we think about what is possible. Questions on collecting data outside of the clinical environment still remain. I.e., how do we accelerate real world evidence (RWE) and data collection?

Today, next-gen digital health platforms enable the scale and use of mobile technologies, electronic patient reported outcome tools, wearables, and biosensors.?

The Burden of Healthcare is Real

Clinical trial procedures often create unnecessary burdens for patients — unnecessary blood draws, imaging scans, and urine collections. Monitoring patient vitals after each dose can lead to negative effects or adverse events with patients. Arranging transportation for patients to receive these tests is costly and time consuming.?

Technology used at trials are poorly implemented with patients finding it difficult to use devices because they are too complex. The list of problems goes on making it no surprise why patients become wary. Their risk of dropping out or not adhering to the medication guidance increases as the clinical trial goes on.?

It is not always so rosy for clinical teams either.?

Although many comprehensive datasets exist based on clinical care, a lack of systematic integration, data sharing, and data standards limits therapeutic development. This makes it difficult to integrate and access siloed data as patients move between providers or seek care in other facilities.

Technology implemented at the clinical trial, onsite or at home, should be an enabler, not a roadblock. If researchers can collect and integrate all the data captured from in-person and remote site visits, they’ll unlock new ways to capture objective measurements and real world evidence (RWE) as clinical trial participants go about their daily lives.

Better Performance Through Decentralization

Use of full or hybrid DCT designs has been hampered, in part due to uncertainty surrounding the effect of remote assessments on data quality and outcomes.

Tailored engagement of a suitable target population may increase participant comfort and convenience, improving satisfaction with and reinforcing the ultimate benefits of DCTs. Pharmacovigilance is mission critical while ensuring the security, accountability, traceability, and compliance to data and IP requirements.

DCTs may have several potential benefits including reduced patient and sponsor burden and increased accrual and retention of a more diverse trial population. The mission should then become expanding decentralized trials across more therapeutic areas, accelerating drug discovery, and preventing deterioration of disease to keep patients safe during studies.?

Totality of Evidence

Even when the data is captured in the EHR, different health care systems may use EHRs in different formats making the data inoperable. EHR (Electronic Health Records) data is supposed to provide more detailed data on the patient beyond information contained within medical claims data. Behavioral (obesity, smoking, alcohol use) and outcomes data (e.g., mortality, symptomatic changes) may not be consistently captured in EHRs or medical claims data. No surprise, EHR-related burnout amongst clinicians is common.

Designing studies that reliably and rigorously combine data from different sources and generate evidence can be used to support regulatory and clinical decision-making. Each successive piece of data builds on prior data to provide the quantity and quality of evidence needed to adequately assess risks and benefits.?

Data from studies can now be assessed within the context of other available data, not in isolation. Doing so effectively allows trials to extend a patients’ follow-up time beyond trial completion to capture additional effectiveness and safety outcomes, while minimizing missing data, and generalizing trial results to real-world target populations.

Enabling providers to spend less time dissecting data and more time providing informed patient care. More effective development and use of RWE (Real World Evidence) requires that information within EHRs be more accessible and connected, with better tools to search these records.?

Digital technologies can improve patient care, yet pose a risk as well. The challenge is a solution that connects or integrates various data sources to form a holistic picture of an individual patient. Doing so effectively reduces the workload of the clinical team during clinical studies.

Where we go from here...

Race, gender, socioeconomic status, or ethnicity should not affect the care we receive. This mandates we increase patient access to care, and improve diagnostics and therapeutics to meet the needs of a growing human population.

The clinical research industry is making strides toward incorporating remote monitoring, virtual clinic visits and virtual enrollment, electronic informed consent (eConsent), and electronic patient-reported outcomes (ePRO), among other digital solutions.

As change today is complex, fast, and extremely hard to predict;?new external threats means that business operations are more disruptive than ever. Hence, we should accelerate adopting solutions that address problems from a holistic approach so we can enable real opportunities to increase the efficiency of research and answer questions that may not have been answered in trials, for example how a drug works in populations and environments that weren’t studied prior.

My next article will be on Real World Evidence (RWE). If you made it this far, thanks for reading. Now go treat yourself!

Do you agree?

Check out what we're doing at Current Health to improve clinical operations at the site level, where sponsors and investigators observe and analyze data in real time. With digitized data immediately visible, site staff can detect and resolve adverse events before they become trial-derailing issues.