Although excitement surrounds the constantly changing landscape of cancer care, we have much to learn to keep our practices current.
Advancements in genomics and cancer precision medicine have improved our ability to differentiate cancers by their genetic mutations. These advancements, in turn, have fueled efforts concerning precision oncology, in which therapies are selected to target cancers based on their genetic mutations. These innovative treatments are commonly referred to as targeted therapies.1
Phase 1: often concerns dose escalation or dose finding with an assessment of dose-limiting toxicity
Phase 2: single arm, to evaluate drug efficacy and safety
Phase 3: randomized, controlled trial to test efficacy and safety vs standard-of-care arm. The results could lead to FDA approval for a new treatment, which usually concerns 1 cancer type. The process to get a drug FDA approved is lengthy and expensive.
The historical use of phase 1 to 3 trials for oncology drug approval was based on the tumor site of origin and the tumor’s histology. Clinical trials have been adjusted to target tumor-specific biomarkers regardless of the tumor type and histology. See Box for definitions of clinical trial phases.
Because it would be challenging to investigate biomarkers based on current trial design, there is a new framework called the master protocol. Master protocol refers to a single design developed to evaluate multiple hypotheses to improve efficiency and establish uniformity based on the presence of specific biomarkers, not tumor types.2
The 3 types of new protocols include basket trials, umbrella trials, and platform trials,1 as seen in the Table.
As oncology nurses, we are excited about the constantly changing landscape of cancer care, as our patients are surviving and often thriving. However, we have much to learn to keep our practices current. These novel clinical trial formats will allow survival advantages and more inclusive enrollment of patients with cancer. The formats can be complicated, time-consuming, and need careful planning. We must carefully analyze the results and know how to interpret the data and the design. You must be well informed before counseling your patients and families. This article gives a brief overview of the types of clinical trials, so I encourage you to review the referenced articles and learn more.
Table. Master Protocol Framework of Clinical Trials
Master Protocol
Definition
Pros
Cons
Basket Trial
Umbrella Trial
Platform Trial
References
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