The recent release of draft guidance from the FDA for conducting decentralized clinical trials (DCTs), inclusive of hybrid trials, offers clarification on the necessary roles of stakeholders throughout the research ecosystem, including that of IRBs. This new FDA guidance defines DCTs as clinical trials in which some or all of the related activities happen outside of traditional sites. Given the sharp rise in the popularity of DCTs, due to the COVID-19 pandemic, this initial guidance was highly anticipated as the industry seeks new ways to reach a wider, more diverse audience while maintaining both participant-safety standards and the quality of data. Achieving these goals becomes more difficult depending on the complexity of your clinical trial, which is generally high for oncology research.
With the administration of infusion therapies to imaging techniques only available at research medical centers to complex assessments, oftentimes oncology trials require traditional, in-person visits. Given this, complete decentralization is generally not an option in therapeutic oncology research, but a hybrid trial often is. Hybrid trials function as a subset of DCTs, bridging the divide between in- and out-of-clinic design, which is particularly important for bringing the benefits of decentralization to complex therapeutic areas like oncology. Among the advantages:
- Expansion of the participant pool made possible by reduced travel to traditional sites, which allows for faster recruitment and better retention, as well as greater diversity of study participants
- Reduction in study costs as a result of lower overhead
- Additional opportunities for real-time data collection
- Decreased burden and potentially an increased quality of life for participants
The industry is actively pursuing these benefits, with the Journal of Clinical Oncology reporting in 2022 that 73% of sponsors and CROs “are planning to run either a DCT or hybrid trial for oncology in the next 12 months,” which was an increase from the 49% planning to do so in the prior 12 months. To responsibly decide which kind of trial to run, factors such as the high rate of adverse reactions to oncology drugs, pre-treatment protocols, and other needs for risk-based monitoring must be weighed. And when you’re ready to get your hybrid oncology trial underway, it’s essential you have the right IRB at your side to safeguard your research and your participants. Some factors to consider:
- The biggest concern in moving to a hybrid trial is making sure there is still adequate oversight to ensure the safety of your participants. When deciding what elements of your study can be outsourced, it’s important that you examine each aspect from the participant perspective as well as from that of the study plan. For instance, while administering certain treatments at home may be entirely out of the question given the potential for adverse reactions, allowing the administration of appropriate treatments at local clinics may lessen the burden and time commitment of participants while widening your recruitment pool. This decentralization, though, requires an evaluation of the capabilities of each local facility, so offering participant convenience and gaining a greater pool of participants may require a larger time commitment on your part up front. For developing the list of considerations against which local facilities should be evaluated, your IRB can provide guidance based on regulatory expertise and oncology research experience.
- Obtaining informed consent remotely is a major element in ensuring participants have all the information mandated, and is an important part of the IRB review process. When obtaining ongoing informed consent, whether it is performed remotely or requires an in-person visit, it is of the utmost importance that participants have a full understanding of the study. Remember that the informed consent for your hybrid trial must include a contact for questions about the research, subjects’ rights, and a contact in case of a research-related injury. There may be additional disclosures for who will have access to personal health information.
- When it comes to data accuracy, it’s important to consider if the technology you plan to use is appropriate for the participant population. Wearables, apps, and other at-home data collection tools increase participant responsibilities, which creates valid concerns about the feasibility of these solutions. Added responsibilities may fall to caregivers to perform the at-home assessments. The usability of the technology depends in part on how effectively you offer clear instructions and training in its use. The regulatory suitability of this strategy should consider whether the caregiver requires informed consent and should be offered compensation. Close and early collaboration with an experienced, flexible IRB can help you determine the right path to compliance based on your specific research and study population.
- There are significant benefits of close collaboration with the IRB. While oncology trials often reach the IRB already developed, you can count on IRB experts to help interpret and apply regulations throughout the process, including for the abundance of midstream changes found in oncology research, whether based on a new drug approval, the development of a new lab test, or simply an element that was not available during protocol development. In order to avoid delays and potential setbacks when making amendments, consult with your IRB to gain guidance from their board, scientific staff, and management, all of whom should have the insight to consider changes from every angle and determine how they do or don’t satisfy existing regulations.
When it comes to conducting a hybrid trial, there is a steady stream of self-perpetuating questions that must be addressed, and this is only exacerbated by the comparative complexity of oncology research. From determining the suitability of a local lab to evaluating the effectiveness of adverse event reporting, there are a multitude of concerns that must be evaluated against existing clinical trial regulations. In order to make the best choice in the shortest time, you need to consult with IRB experts who can draw on hands-on expertise to accelerate your decision making. As in every type of clinical trial, the safety of the participant is of paramount importance in the conduct of hybrid trials, and close collaboration with professionals is the best way to ensure it. Not all IRBs, of course, are equal. Seek out a board that includes oncologists who stay up to date with standards of care and other current practices specific to oncology to ensure you’re getting advice guided by the most recent views. To complement this institutional skill set, you also need an IRB with a little imagination. While the new draft guidance helps answer a number of questions, creative approaches that satisfy both the needs of your study and the safety of your participants have become the new norm. An agile IRB takes the time to translate present guidance to your trial, including applying the necessary scrutiny to new ways of doing things. By entering an early and close partnership with an experienced IRB, you get answers that keep your participants safer and your research on track.
Have an oncology trial on the horizon? Explore all the ways Sterling IRB brings knowledgeable, creative solutions to every challenge at https://www.sterlingirb.com/.