Oncology Clinical Research
Oncology continues to be one of the most active therapeutic areas in clinical trials. With significant funding from industry and federal agencies, the field is often the first to investigate new treatment modalities, technologies, and discoveries.
With this tradition of innovation comes the challenge of determining how new approaches fit into regulatory plans, clinical operations, and more.
How is the oncology clinical research community addressing diversity, equity, and inclusion (DE&I)?
Technology for Conducting Oncology Clinical Trials
Recruitment and retention are particularly challenging when working with very specific inclusion and exclusion criteria. Managing research data can also be difficult, as sites must meet additional reporting requirements from the National Cancer Institute (NCI). And because cancer patients often face grave diagnoses, extra care must be taken to ensure they truly understand what study participation requires.
To find sites with access to the right patient populations, sponsors, and contract research organizations (CROs) may choose to inform feasibility and site selection with site performance data.
Technology like a clinical trial management system (CTMS) can help research sites better manage study activities and report on oncology research data. Automating certain tasks can also help make more time available to focus on participants. However, when sponsors mandate study-specific technology to manage their cancer trials, sites may find the myriad systems a burden. 78% of NCI-designated clinical research sites use Advarra’s OnCore CTMS.
For sites outside of the U.S., sponsors should ensure they provide site-centric and integrated tools to support sites conducting complex research.
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Compliance and Safety in Oncology Clinical Research
Clinical trial safety and compliance are paramount for every type of study, but oncology trials also have special concerns specific to the field.
- Institutional review boards (IRBs) often have unique considerations with oncology protocols, as risk/benefit evaluations may be different from other therapeutic areas.
- The growing number of sIRB requirements for multisite studies adds challenges for institutions historically reliant on local IRB review and lacking sIRB processes.
- Phase I oncology trials in particular have unique ethical concerns to manage, given their role in collecting initial clinical safety data.
- NCI-designated cancer centers must meet additional requirements to maintain that designation.
- Cancer trials involving cell and gene therapy likely require institutional biosafety committee (IBC) review (in addition to IRB review), requirements which may be unfamiliar to those new to genetic research.
- Most cancer clinical trials require data safety monitoring board (DSMB) oversight, which must remain independent of study conduct to provide unbiased recommendations regarding safety signals and trends.
- Specialized medical expertise may be needed to ensure data are reviewed appropriately when assessing whether a study event is related to the research and/or its defined endpoints.