Assessing the Covid Impact to Clinical Research


How Challenging Clinical Research Norms Can Transform Drug Development — Key Takeaways from the Getting Life Sciences Back to Better Webinar

eClinical Solutions recently hosted a live panel with industry leaders to discuss how the biopharmaceutical industry can emerge from the Covid-19 pandemic stronger than ever, and how clinical drug development is transforming based on new models of collaboration and technology.

With the need to develop therapies as quickly as possible and the increasing decentralization of clinical trials, Covid-19 has become a catalyst for long-lasting change in the industry. Webinar panelists Raj Indupuri (CEO and Co-Founder, eClinical Solutions), Joseph Panetta (President & CEO, Biocom Board of Directors) and John Reites (President & CEO, THREAD Research) discuss the ability to develop drugs and a Covid vaccine within timeframes that are shorter than the industry average, the skills that clinical teams need to respond to the rapid pace of these developments, and what this means for establishing repeatable and sustainable processes for future clinical research.

Lessons Learned from Covid-19: 3 Key Points to Move Clinical Research Forward

1. Collaboration is Essential

The focus on accelerating timelines to develop a Covid 19 vaccine has forced a new sense of shared purpose and cooperation among government agencies, pharmaceutical companies and clinical researchers. This can be seen in how the industry has risen to meet current challenges by building a coronavirus knowledge base together. As Panetta notes, “I’ve been in this industry for 32 years, and I’ve never seen anything like this level of collaboration before.” The work does not stop with Covid vaccine development though. Panetta continues: “We need to be fully prepared for the possibility of another pandemic and be more aware of the need to develop therapies and diagnostics quickly. To accomplish this, there needs to be less of a tug of war between the government, our healthcare and the biopharmaceutical and medical device industries.”

2. Plan for Remote Monitoring and Data Capture by Investing in Modern Infrastructure

There is a fundamental shift in how clinical studies are being conducted, with visits moving from clinics to homes. Trial virtualization is here to stay, and this significant change means that adopting remote approaches to monitoring and capturing clinical data is imperative, not only for the development of a Covid vaccine, but for other ongoing trials. Patients are missing visits for existing studies, so sponsors need the ability to gain insights into the impact on enrollment, protocol deviations and delays with data capture.

A modern clinical data management infrastructure and data pipeline support greater visibility into the impact that the pandemic is having on existing trials. With a pipeline in place, the collection and standardization of diverse data sources can be automated. This ensures data quality and prepares data for the application of advanced analytics, which then drives actionable insights, encourages better decision making and minimizes risk.

3. Unlock Data Science, Genomics and “Stakeholder” Skills to Succeed

Clinical development leaders must foster specific skill sets in their clinical teams in order to navigate this new environment in drug research successfully. Understanding how technology works—and how best to use it—will ensure that the tools and solutions being implemented to drive efficiency in clinical research can be optimized.

Enhancing data science skills takes this idea one step further by making these tools actionable. As Indupuri explains, “Data science is a large skill set that companies need to develop between their data scientists, DMs and clinical operations teams in order for them to evolve and augment their data intelligence from machines so that you can effectively impact patients.”

Covid-19 has also highlighted the increasing importance of genomics and epidemiology in clinical trials. Understanding population groups and their genetics are crucial in current studies of the virus, and building skills in these areas will be vital in advancing clinical development in the future.

The ability to think like a patient, rather than thinking about a patient, is another important skill. To inhabit a patient’s and site’s perspectives means all relevant points are being considered when designing and implementing a study. Reites calls this “the stakeholder skill, which is the skill of thinking through everything we do from the vantage point of all the stakeholders in a study.”

Q&A: How Can Covid’s New Standards Serve as a Blueprint for Future Drug Development?

Indupuri: The investment in new technologies is long-lasting, whether it’s changing processes or bringing research to patients. This is now accelerated and one of the benefits of technology-driven innovation is that it’s repeatable and scalable. It can also be applied seamlessly for other therapies as well. For instance, mining real-world data from claims in insurance databases or from old trials will help with better protocol design, more adaptive trial design and synthetic control databases. This will actually help reduce cycle times and address any issues with enrollment, patient enrollment and other aspects of research.

Reites: The emerging blueprint presents two different ways to think about it. We thought Covid was going to be short-lived, so we created one express blueprint for supporting and making sure patients don’t miss visits for several months. The second approach imagines what we would do if this happens again. It required us to ask ourselves how we can incorporate or implement decentralized trial approaches and make content more flexible. All of the options we use for a normal part of decentralized trials, like telehealth and flex e-consent forms, need to be placed into a blueprint for an alternative solution to every kind of visit we have.

Panetta: Our ability to do things more efficiently with big data, remotely, and in ways that cut down on costs, is going to contribute significantly in the future toward reducing the development timeline and the costs. We’ll be moving through the process a lot more quickly, especially for those 99 products that don’t make it all the way through.

Get Life Sciences Back to Better

Though there have been many challenges, the pandemic has also encouraged innovation and cooperation in the life sciences industry. The new solutions and processes that have emerged as a result will continue to drive clinical research in the future. 

How can sponsors enable collaboration, improve data access, and support faster decision-making and agile flexibility to program changes? Draw on eClinical Solutions’ deep clinical trial expertise and core technology platforms by scheduling a demonstration with us today.

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