From concept to patient: How an Alliance cancer clinical trial is born
Developing a cancer clinical trial is a rigorous, collaborative process designed to address important scientific questions while protecting participants and maintaining high standards for study quality and data integrity. The Alliance supports several pathways for turning research ideas into clinical trials:
- National Clinical Trials Network (NCTN)/NCI Community Oncology Research Program (NCORP) Pathway: Supported and funded by the National Cancer Institute (NCI), these trials address important questions in cancer prevention, treatment, and control that can inform clinical practice and national standards of care.
- Alliance Foundation Trials (AFT) Pathway: These trials are supported through independent research grants, foundations, pharmaceutical and industry partners, and other non-federal organizations to evaluate innovative therapies aligned with Alliance scientific priorities.
- External Collaborator/Partner-Supported Trials Pathway: These studies originate through external collaborations where Alliance institutions, investigators, and infrastructure contribute scientific expertise, patient enrollment, or trial operations. Although initiated outside the Alliance’s concept pipeline, these trials can leverage Alliance’s national network and operational capabilities.
Regardless of the pathway, Alliance clinical trials follow a structured lifecycle from concept development and review through participant enrollment, data collection, analysis, and reporting. Results from completed trials can inform the next stage of research, including late-phase studies or, when the evidence supports it, regulatory review and changes in clinical practice.
Every clinical trial begins with an important research question. An Alliance researcher might ask: “Can a new targeted therapy given immediately after surgery to prevent recurrence in patients with early-stage cancer?”
- Developing the concept: The investigator, who may serve as the Study Chair, develops a concept outlining the scientific rationale, targeted participant population, and key research endpoints.
- Committee review: The investigator submits the concept to the relevant Alliance scientific committee where experts review and refine the proposal. The committee considers the scientific rationale, patient need, feasibility, and potential impact to determine whether the concept is ready for further development.
Once the scientific committee approves a concept, Alliance programs provide the expertise and infrastructure needed to develop it into a rigorous clinical trial.
- Protocol development: The Alliance clinical operations team works with the Study Chairs to develop the formal protocol—the detailed scientific, ethical, and operational plan that guides the trial.
- Statistical and data planning: The Alliance Statistics and Data Management Center (SDMC) develops the statistical design needed to answer the research question, including determining the appropriate sample size and methods for analyzing the results. The SDMC also established the systems for collecting and managing study data.
- Translational research planning: The Alliance Translational Research Program (TRP) integrates molecular and translational endpoints into the study, including plans for collecting, managing, and storing tumor tissue and blood samples through the Alliance biorepository resources for future analysis.
Once a trial is fully developed, its operational and review requirements depend on how the study is funded and sponsored. The Alliance supports three primary pathways:
| Feature | NCTN/NCORP pathway | AFT pathway | External collaborator pathway |
|---|---|---|---|
| Funding | National Cancer Institute (NCI) and federal grants | Pharmaceutical or biotech companies, foundations, and other non-NCI organizations, including PCORI | May include NCI or other federal funding, foundations, or external partners |
| Protocol management | Managed by the Alliance Central Protocol Operations Program (CPOP) | Managed directly by Alliance Foundation Trials, LLC (AFT) | Managed by the Alliance Central Protocol Operations Program (CPOP) or as defined by the collaboration |
| Review and oversight | Follows applicable NCI scientific, regulatory, and operational review requirements; may include the NCI Steering Committee | Follows AFT and sponsor-specific scientific, regulatory, and ethical review requirements | Review and oversight depend on the funding source, sponsor, and terms of the collaboration; may include the NCI Steering Committee |
The pathway determines how funding is secured, who manages the protocol, and which review and oversight processes apply. Regardless of pathway, every trial must meet applicable scientific, ethical, regulatory, and participant-safety requirement before enrollment begins.
Before a trial can enroll participants, it must undergo appropriate ethical and regulatory review to protect participants and ensure compliance with applicable federal, state, and institutional requirements.
- FDA requirements: When applicable, the Alliance and study sponsors work with the U.S. Food and Drug Administration (FDA) to meet requirements for investigational drugs and devices. Trials involving an investigational drug or an approved drug being studies for a new indication may require an Investigational New Drug (IND) application. Studies involving investigational devices may require an Investigation Device Exemption (IDE).
- IRB review: The protocol and Informed Consent Form undergo review by an appropriate Institutional Review Board (IRB). For eligible NCI-sponsored trials, review may be conducted through the NCI Central Institutional Review Board (CIRB), with institutional requirements addressed as applicable. IRBs independently evaluate the study’s risks and benefits, participant protections, and informed consent process to help ensure that risks are minimized and communicated clearly.
Once funding and required approvals are in place, the trial moves into activation. The Alliance Central Protocol Operations Program or, for AFT studies, the AFT Clinical Operations team, coordinates the final steps needed to launch the study across participating sites.
- Trial launch: The study is registered on ClinicalTrials.gov and, when open for enrollment, listed as Active/Open to Accrual on the Alliance clinical trials website.
- Site activation: Alliance coordinates implementation across participating member institutions, affiliate hospitals, and community cancer centers. Sites review the protocol, assess their ability to enroll eligible patients, and complete the requirements for activation. Not every trial is available at every site.
- AFT site selection: For AFT studies, the AFT Clinical Operations team works with the study partner to select participating Alliance sites based on factors such as membership and project accrual.
- Participant enrollment: Research coordinators, data managers, pharmacists, and other site staff complete study-specific training and activation requirements. Once a site is open, local oncology teams screen eligible patients and begin enrollment.
Learn more about drug and device approvals through the U.S. Food and Drug Administration.