The Future Feature, with Joseph Lengfellner | Read now

Medable, Inc caught up with noted oncology research informatics expert, Joe Lengfellner , to discuss what he perceives as the biggest breakthroughs in clinical research to date, & what he thinks our industry should strive towards in the future.

Note: The opinions offered during this interview reflect the views of Joseph Lengfeller only, and do not represent those of Memorial Sloan Kettering Cancer Center.

What's one thing you wish everybody knew about your job?

In my role, I have the privilege of not only guiding highly proficient technical teams, but also working with leaders in all realms of clinical trials. This unique position has afforded me the chance to build a comprehensive understanding of business obstacles spanning the entire clinical trial landscape, and to serve as an ally in identifying innovative technological solutions for these challenges.

For an organization to adopt a forward-thinking mindset in tackling intricate business problems, it is crucial to have technology leaders actively participating in the decision-making process. In my current role, I have been granted this invaluable opportunity, which has significantly enriched my knowledge of the industry. Navigating this dynamic environment is simultaneously exhilarating, demanding, and fulfilling, making it a truly rewarding experience!

In an ideal world, how would clinical research be done?

In my ideal world, the entire clinical research pipeline would be fully digitized from end to end. Starting with the initial protocol document, every aspect would be structured, codified, and reusable. Inclusion and exclusion criteria would rely on industry data standards, allowing for seamless integration with clinical trial matching software. The eConsent would be generated based on the codified study design and associated protocol information. The schedule of assessments would also be structured so that both research teams and patients could consume the data in useful ways. The opportunities that arise from a digitized study design are virtually limitless!

In this idealized future state, both the development and data population of downstream systems, such as EDC and CTMS, could eventually become automated. Protocol amendments would be far less burdensome when all related systems can be updated directly from the source. While this may be an ambitious goal, achieving it would enable the industry to make significant progress in accelerating trial activation and execution, driving innovation and improving patient outcomes.

What's one barrier to research that's not being talked about enough?

The role of site study coordinators is crucial for the successful execution of a clinical trial, as they are responsible for a wide range of tasks such as patient recruitment, study logistics, data collection, addressing inquiries, and ensuring patient care and safety by monitoring adverse events and deviations.

As an industry, we should be talking more about the challenges faced by these critical team members and identify ways to improve their experience—they are truly invaluable!

What's one consumer experience you wish you could bring to clinical research?

On a personal note, I have always found great satisfaction in exploring automation tools such as IFTTT.com, Zapier.com, or even the Shortcuts app on my iPhone. For those unacquainted with these platforms, they offer a user-friendly approach, often utilizing drag-and-drop functionality, to connect data and features across multiple applications. For instance, with Zapier, one can effortlessly create a workflow that sends a private Slack message each time a specific Google Sheets file is updated. Another example is automatically generating a to-do item in a task manager when an email receives a certain label. The possibilities are virtually endless.

Considering the vast array of digital tools employed in managing clinical trials, I can envision a world where we can automate and integrate these processes with the same level of simplicity. Imagine a scenario where a patient completes an eConsent form, and as a result, a record is instantaneously created in the EDC and CTMS systems. Simultaneously, an ePRO survey is dispatched to the new patient, and an email is sent to a scheduling team to confirm the patient's initial research appointments. Moreover, the patient can subscribe to updates, synchronizing their calendar or preferred to-do app. While some platform solutions in the market can address selected cases, the ever-growing number of clinical trial tools makes the development of comprehensive integration solutions an intriguing and worthwhile challenge to undertake.

If the industry could just _____ things would work better.? Explain why.

Find ways for tighter collaboration between sponsors, sites and technology providers

While I've seen progress in this area, there remains room for enhanced collaboration between sponsors, sites, CROs, and technology providers. One of the best ways we can accelerate clinical trials is by seeking ways to improve cooperation among all parties involved. By working together and adopting a more collaborative mindset, we can tap into the potential for greater efficiency and innovation, ultimately making a positive impact on the world of clinical trials and the patients we serve.

In your view, what is the smartest/best advancement in clinical trials that's happened in the past 5 years?

I am genuinely excited by the advancements in EHR-to-EDC technologies. Although the concept has been in existence for longer than five years, it seems as if a paradigm shift has occurred, priming the industry for accelerated adoption. From the perspective of a clinical trial site, I have witnessed the challenges associated with EDC data management and experienced firsthand the benefits of alleviating this burden.

What fuels my optimism regarding the success of EHR-to-EDC technology is the clear alignment of interests between sites and sponsors. Such tight alignment is not always evident in these initiatives, which makes the widespread adoption of this technology even more likely. An effective implementation can reduce operational costs, increase quality, and speed trial execution, wins for all stakeholders involved.

Initially, the focus has been on structured data, such as laboratory results, vital signs, and medications. However, it is already evident that AI/ML models can interact with EHR-to-EDC pipelines to facilitate EDC entry for unstructured data as well. I fully expect rapid expansion of this technology's adoption in the coming years and look forward to observing its transformative impact on the clinical trial industry.