While the Alliance for Clinical Trials in Oncology conducts many clinical trials through the National Cancer Institute’s National Clinical Trials Network (NCTN), Alliance Foundation Trials, LLC (AFT) is a separate, nonprofit research organization established in 2014. AFT allows researchers within the Alliance network to conduct important cancer studies using funding from sources other than the NCI, such as pharmaceutical companies and independent research organizations like the Patient-Centered Outcomes Research Institute (PCORI).
Although AFT is funded differently, it relies on the same nationwide network of physicians, researchers, statisticians, academic and community centers that participate in Alliance clinical research. This allows promising studies to move forward when federal funding is unavailable or when a different funding model is more appropriate.
How an AFT trial becomes a reality
An AFT trial begins when a physician or researcher identifies an important question about cancer care that has not yet been answered. This may involve testing a new treatment, evaluating a new combination of existing therapies, or studying ways to improve patients’ quality of life. The researcher presents the idea (also called a concept) to the appropriate Alliance disease committee, where experts review its scientific merit, feasibility, and benefits to patients.
If the concept is approved, the study team develops a detailed study protocol. The protocol serves as the instruction manual for the trial, describing who can participate, how the treatment will be given, what information will be collected, and how participants will be monitored throughout the study. At the same time, the Alliance biostatisticians determine how many participants will be needed and design the study so the results can answer the research question reliably.
Unlike many Alliance studies funded by the NCI, AFT trials obtain financial support from other sources. Depending on the study, funding may come from pharmaceutical or biotechnology companies, nonprofit organizations, or independent research grants, including organizations such as PCORI.
Before a trial can begin enrolling participants, it must undergo careful ethical and regulatory review. If required, the study is reviewed by the U.S. Food and Drug Administration. In addition, an independent Institutional Review Board (IRB) reviews the protocol and informed consent documents to ensure the participants’ rights, safety, and welfare are protected.
Once funding, scientific review, and regulatory approvals are complete, the trial is opened for enrollment. The study is registered on ClinicalTrials.gov, participating academic and community centers receive training, and eligible patients may be offered the opportunity to participate. Because AFT uses the Alliance nationwide research network, many patients can access these studies close to home through participating hospitals and medical centers.
Here’s a link to the current AFT trials actively enrolling new patients.