Patient-Centered Drug Development Leads the Way in 2022

This year patients will drive changes in drug development and cancer care.

From broader adoption of real-world data to expedite vaccine availability for patients to innovations in antiquated clinical trials, 2021 has been another year of change, challenge, and innovation in both healthcare and the life sciences. What was unique this past year was the fast-tracked adoption of emerging technologies by the life sciences industry as they fought to continue serving patients’ near-term needs, while also driving development of their pipelines. 

As we reflect back on the year and lessons learned, there are a few areas ripe for growth and investment in 2022. Read more from COTA’s Chief Strategy Officer, Miruna Sasu, and her predictions for 2022 below.

Clinical trials will look different

In 2021, a severe lack of diversity and representation in clinical trials took center stage. While much discussion was had on this issue over the past year, I expect action in the year ahead – starting with further expansion of decentralized clinical trials. We’ll see more life sciences organizations adopting strategies and emerging technologies (such as remote-patient monitoring technology) that bring clinical trials further into communities in order to improve access to potentially life-saving drugs and therapies for devastating illnesses.

Choice will also be in patients’ hands when it comes to clinical trials in 2022 – from more options for home-based testing to acceptance of self-reported patient outcomes data, to broader adoption and coverage for virtual care visits and check-ins. We are already seeing this come to fruition as companies like CVS Health and Quest Diagnostics expand efforts to power home-based blood draws to simplify health data gathering for patients involved in clinical trials.

Real-world data will play a more prominent role in drug development

The pandemic shed light on the power and potential of real-world data (RWD) to drive efficiencies in clinical trials and overall vaccine development. This year, the FDA also released more guidance on RWD as well – providing clarity in some areas, and driving questions in others. 

For 2022, I expect more guidance from the FDA on RWD – likely in relation to how the most important high-quality real-world data can best be captured starting at the point of care. This guidance will, over time, help ensure the most accurate and comprehensive data is collected from patients and then shared in a secure and private way with both providers and life sciences companies that are looking to personalize and optimize patient treatments and outcomes. This may be a bit longer time horizon, but I also expect other countries to reconsider their stringent patient data privacy rules as they see the U.S. making strides forward in accelerating drug development.

Also, the types of real-world data that are accepted by the FDA for submission will undoubtedly broaden, including biomarker data, genomic data, patient-reported outcomes data, and even more consumer-focused data elements like financial data. 

With 83% of oncologists stating real-world data is critical to accelerating cancer research and treatment, we also expect more providers and life sciences companies to invest in creating teams that will own real-world data strategy and innovation – helping to push patient care, clinical trials, and R&D into a new era of value-driven, preventive medicine.

Real-world data will also become the foundation for several other technologies and analytical capabilities to develop, so the trend we have seen around developing predictive algorithms and technology to interrogate the data for continuous insights will definitely continue. We already see several companies adding capabilities through mergers and acquisitions that are pointing the industry in that direction. Now drug developers and the FDA will just need to start utilizing those capabilities so that patients actually benefit from big data and analytics.

The collateral damage of COVID-19 will become a primary concern

COVID-19 has had a devastating effect on the nation’s health. In addition to hundreds of thousands of deaths directly caused by the virus, millions more patients have been unable to access crucial healthcare services due to lockdown orders, economic stress, and fear of illness. 

During the early days of the pandemic, primary care visits declined by nearly 60 percent before rebounding later in 2020. And screenings for common cancers, including breast, colon, and cervical cancer, dropped by an average of 91 percent, prompting fears of a wave of advanced cancers in the coming months. In 2022, we will start to experience the real-world impact of these delayed screenings and routine care. I predict we will see an increase in cancer diagnoses – particularly at a later stage.

Throughout the pandemic we have been encouraged to “trust the science” and “rely on the data.” This has changed patient expectations and we will see that play out in cancer care. As a result, and perhaps a silver lining, the demand for precision oncology and data-driven cancer care will be stronger than ever before in 2022.