In the midst of the COVID-19 pandemic, a new ASCO article reports that oncology research programs are experiencing delays and other challenges in advancing clinical trials during this unprecedented time. The article, which published today in JCO Oncology Practice and was previewed during ASCO’s recent presscast on COVID-19 and cancer care, looks at the types of changes and challenges to clinical trials that research sites experienced early in the pandemic. Data from the article comes from a March 2020 survey of oncology research programs, including both academic- and community-based research programs.
The survey found:
- Research delays are common. Nearly 60% of programs halted screening and/or enrollment for certain clinical trials, and 59% stopped research-only visits, except those visits where cancer treatment is provided.
- Remote interactions are a standard part of the clinical trial process, with 66% of programs reporting remote site initiation visits and 72% reporting remote monitoring by sponsors and/or contract research organizations (CROs).
- Programs report a range of challenges, including decreased patient ability/willingness come to their site; staff time needed to organize, implement, and conduct telehealth visits; and limited availability of ancillary services (e.g., radiology, surgery, cardiology, etc.). Duplicative and inconsistent communications from industry sponsors and CROs were also challenging.
In the article, ASCO issued recommendations for programs to consider adopting during pandemic, including:
- Develop formal COVID-19 standard operating procedures for clinical trials that could be repurposed with other disease outbreaks.
- Leverage e-signatures for informed consent and other study documents.
- Promote telehealth visits for patients.
- Implement patient review of symptoms and adverse events (e.g., through patient portal, email, phone, video).
- Ship oral drugs directly to patients.
- Ensure transparency and thorough documentation of changes to procedures and modifications to or deviations from protocols.
The article calls for the cancer research community to monitor and assess the impact of the pandemic on access and recruitment to clinical trials of racial and ethnic minorities, rural communities, older adults, and other underserved groups. It also argues that the research community should evaluate the impact of clinical trial protocol modifications to determine if they can safely and successfully continue after the pandemic. All stakeholders in the research community are urged to seize this opportunity to simplify the conduct of clinical trials by making permanent the positive adaptations to clinical trials that were introduced during the pandemic.