Science 37 Forecast—The Adoption of Hybrid Oncology Trials Will Accelerate in 2023 & Beyond
Oncology is a therapeutic area of singular importance in clinical research. R&D spending in oncology was set to top US$70 billion in 2022, making it the largest research market by some distance, accounting for almost one-third of the total drug R&D budget. Globally, there are currently 3,718 active clinical trials in oncology, investigating 2,160 treatments from 1,903 companies, according to Evaluate Pharma. More than 26,000 investigators are conducting these studies across over 11,000 sites.
There is tremendous innovation in oncology clinical research, particularly in the areas of precision oncology, immuno-oncology, and cell/gene therapies. Breakthroughs in drug discovery will catalyze numerous studies for targeted cancer treatments, with Evaluate Pharma forecasting that the number of oncology clinical trials could exceed 10,000 by 2026.
Opportunities for new clinical trial approaches in oncology
Oncology has trailed other therapeutic areas in one notable respect: a slower rate of adopting hybrid and decentralized clinical trial modalities. Oncology is differentiated as a therapeutic area by the need for a primary caregiver. This is because cancer treatment options and regimens are complex, and patients often have a high disease burden—which heavily impacts their quality of life. Frequent testing is required to monitor tumor progression and therapy effectiveness.
While oncology research may have trailed other indications in the adoption of hybrid and decentralized clinical trial modalities, the shift towards hybrid studies is advancing. A recent global survey commissioned by Science 37 of clinical research executives in oncology found that more sponsors and CROs were expecting to execute hybrid clinical trials than traditional trials in 2022. In fact, 73% of clinical research executives in oncology plan to implement decentralized components in their studies, up from just 49% in the prior year.
Innovations driving adoption of hybrid studies
Several factors have coalesced to improve the feasibility of hybrid and decentralized clinical trials in oncology, which were discussed in the Journal of Clinical Oncology1. Oral, subcutaneous, or intramuscular therapies with proven safety profiles and supply chains are well-suited for hybrid studies.
Digital technologies also play a vital role for both patients and clinicians. Endpoint devices enable much of the data collection to occur virtually via electronic patient-reported outcomes (ePROs) and wearable devices. And DCT technology platforms provide virtual sites (such as The Science 37 Metasite) to expand beyond traditional sites and onboard community oncologists, capture patient consent, enable telehealth visits, and more.
Given the disease burden and the stresses of treatment, robust clinical care must be in place for non-traditional oncology trial models to gain momentum. Requirements include role clarity between primary oncologists and clinical trial teams, mobile and remote nursing staff for safe delivery and monitoring of home-based treatments, and access to nearby healthcare facilities.
Protocol guidance and encouragement from regulatory bodies have contributed to the uptake of DCT in oncology. The FDA has expressed support for this approach, stating, “Decentralized clinical trials hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population, a key goal for the FDA Oncology Center of Excellence2 (OCE) programs including Project Equity and Project Silver.” Governmental guidelines about patient referrals to studies, diversity in drug research, as well as payer policies that cover at-home treatment and monitoring, are also vital to the broader adoption of hybrid trial models.
Hybrid clinical trials and the use of the Science 37 Metasite are gaining significant traction in the oncology research landscape, spurred by the adoption of new approaches during the pandemic, and continued through advances in drug delivery, digital technologies, and at-home care models. Stakeholders ranging from sponsors and sites, to patients, see significant benefits, including universal access to patients and providers, faster enrollment, higher retention rates, increased diversity, improved patient experience, and better-quality data.
To learn more about how Science 37 is bringing hybrid trial capabilities to oncology studies with the Science 37 Metasite, please read the new Oncology Playbook.