Bringing a new cancer clinical trial to life is a rigorous, highly collaborative process designed to ensure scientific excellence, data integrity, and patient safety. Within the Alliance for Clinical Trials in Oncology (Alliance), this journey leverages our vast network of more than 26,000 cancer specialists, statisticians, research participants, and patient representatives across North America.
From concept to patient: How an Alliance cancer clinical trial is born
To maximize the impact of cancer research, the Alliance utilizes several distinct pathways to transition a scientific question idea into a research trial:
- National Clinical Trials Network (NCTN)/NCI Community Oncology Research Program (NCORP) Pathway: These studies are supported and funded by the National Cancer Institute (NCI) to address questions that may help shape national standards of care practices in oncology.
- Alliance Foundation Trials (AFT) Pathway: AFT studies are collaboratively funded through independent research grants, foundations, pharmaceutical and industry partners, or non-federal organizations to evaluate innovative therapies that align with Alliance scientific priorities.
- External Collaborator/Partner-Supported Trials Pathway: These studies are initiated through external collaborations where Alliance institutions, investigators, and infrastructure contribute to the trial conduct, accrual, or scientific expertise. These studies still leverage Alliance’s operational structure and systems, including the member networks, but originates outside the Alliance concept pipeline.
No matter which pathway a clinical trial takes, it moves through a synchronized lifecycle from concept and research participant enrollment to data collection, analysis, and public reporting. If a clinical trial proves that a treatment is safe and effective, researchers may advance to the next phase trial or submit findings to regulatory agencies such as the U.S. Food and Drug Administration (FDA) for review. The FDA independently evaluates the available evidence to determine whether a treatment is safe and effective for its intended use and whether its benefits outweigh its risks.
Every clinical trial begins with a vital question asked by an Alliance researcher. For example, a research scientist might ask: “Can we use a new targeted therapy immediately after surgery to actively prevent recurrence in patients with early-stage cancer?”
- The concept proposal: The investigator (who may serve as the Study Chair) drafts a concept outline detailing the scientific rationale, the targeted participant population, and the desired scientific endpoints.
- Alliance Scientific Committee Evaluation: The investigator submits the concept to their peers within the relevant Alliance scientific committee. A multidisciplinary panel of oncologists, statisticians, oncology nurses, clinical research professionals, and patient representatives rigorously assess the idea to ensure it addresses an urgent patient need and meets the high standards of the Alliance Scientific Review Committee.
Once the scientific committee approves the concept, the trial is developed through the coordinated support of the Alliance’s core programs.
- Protocol development: The Alliance clinical operations team works directly with the study chairs to draft the formal protocol. A protocol is a comprehensive document that acts as the exact medical, ethical, and logistical instruction manual for the trial.
- Biostatistics integration: The Alliance Statistics and Data Management Center (SDMC) is engaged to ensure the trial’s statistical design will answer the question. Alliance biostatisticians determine the required sample size to ensure the study is scientifically conclusive and develop the secure data systems used for trial data collection. This is a very important component, as a trial is only as good as its data. Without a rigorous, mathematically sound blueprint, even the most promising medical discovery can fail to demonstrate its true impact.
- Translational integration: The Alliance Translational Research Program (TRP) works to integrate scientific bio-endpoints, establishing how tumor tissue or blood samples will be collected and managed by the Alliance Biorepository System for future molecular analysis.
At this stage, the study follows distinct operational tracks based on its funding structure.
Feature | NCTN/NCORP pathway (publicly funded) | AFT pathway (independently funded) | External collaborator pathway |
| Primary funding Source | National Cancer Institute (NCI) and federal grants | Pharmaceutical partners, biotech firms, or independent grant makers (such as PCORI) | National Cancer Institute (NCI), federal grants and/or foundations |
| Protocol management | Managed by the Alliance Central Protocol Operations Program (CPOP) (link) | Managed directly by Alliance Foundation Trials, LLC (AFT) administration (link) | Managed by the Alliance Central Protocol Operations Program (CPOP) (link) |
| National review | Requires formal evaluation and approval by the NCI Steering Committee to ensure alignment with federal public health priorities | Evaluated and approved via direct negotiation between AFT leadership and the industry sponsor or grant provider | Requires formal evaluation and approval by the NCI Steering Committee to ensure alignment with federal public health priorities |
Before a single person can participate, the trial must undergo rigorous ethical and regulatory review to ensure patient safety and compliance for federal and local rules and regulations.
- FDA coordination: If the study involves a new investigational agent or an approved drug being tested in a new indication, an Investigational New Drug (IND) application is maintained to ensure federal compliance and patient protection. For studies involving new devices, an Investigation Device Exemption is filed with the Food and Drug Administration to collect safety and effectiveness data.
- Centralized IRB review: The protocol is reviewed through a centralized Institutional Review Board (IRB) and also may be reviewed at a local institutional IRB. This independent panel of medical experts, ethicists, non-scientific members, as well as patient representatives thoroughly evaluates the study design and the Informed Consent Form to ensure participant risks are minimized and clearly communicated in plain language.
Once funding is secured and regulatory approvals are granted, the trial moves into the activation phase, coordinated by the Alliance Network Group Operations Center or the AFT Operations Unit.
- Launch: The trial is officially registered on public databases like ClinicalTrials.gov and designated “Active/Open to Accrual” status.
- Network-wide onboarding: The Alliance coordinates rollout across its main member institutions and affiliate hospitals and community cancer centers. During this phase, sites review the protocol to determine whether it aligns with their patient populations and clinical priorities. Because each study has specific eligibility and operational requirements, not all trials are activated at every participating site.
- AFT-specific onboarding: The AFT Clinical Operations unit coordinates the selection of Alliance network member sites with the partner supporting the trial. Alliance network sites will be approached by AFT and invited based on membership status and accrual criteria.
- Enrolling participants: Research coordinators, data managers and pharmacists at participating sites complete study-specific training. Local oncologists then begin screening and enrolling eligible participants.
To learn more about drug and device approvals, please review the U.S. Food and Drug Administration flowcharts.