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Halabi Named Fellow, American Society Of Clinical Oncology

Beaver, Gideon Blumenthal, and Richard Pazdur. Neil Palmisiano, Bradley M.

Oncology Clinical Trials: Successful Design Conduct And Analysis

Cecilia R. Steven J. Lemery, Gideon Blumenthal, Paul G. Edited By: Lisa H.

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Compare Products. You have reached the maximum number of selection. You can select only upto 4 items to compare. View Order. More than one-third of all oncology trials do not include a North American site, and the percentage of patients accrued in the United States is even less. The relative abundance of small, early-phase, single-arm, and open-label studies in oncology can be partially explained by a few selection pressures. First, accelerated approval was embraced by the US Food and Drug Administration FDA in to improve access to treatments for life-threatening diseases 31 and subsequently expanded to cover applications for new molecular entities in oncology.

This results in variations in the number of phase 3 trials that are performed after approval. Second, regulations support the off-label use and reimbursement of antineoplastic agents. Because postmarketing evidence requirements for off-label use are less stringent than those for FDA approval, evidence development is inconsistent in this space and frequently ends at phase 2.

Although these policies can be defended, we must ensure that the resulting research can answer the pressing questions in oncology. There is an inherent tension between the desire to use new, life-saving treatments and the imperative to develop the evidence base that patients, clinicians, regulatory agencies, and advocacy groups need to make sound decisions. Unfortunately, the high prevalence of small trials that lack comparator arms, rely on historical controls, and lack randomization limit the ability to assess the evidence supporting specific treatments through systematic reviews and comparative effectiveness research.

As the national debate regarding research priorities continues to unfold, the research community must take into account competing priorities, the importance of particular research questions, the urgency of disease, and the availability of trials across geographic regions and disadvantaged populations. Although discovering breakthrough treatments must be a priority, understanding and improving the use of existing treatments is likewise essential. Nations such as the United Kingdom 36 attempt to coordinate and manage their approach to clinical research to align it better with public health priorities.

The United States has not made similar progress. Through this work, we hope to stimulate a discussion of the present state of oncology research, one that addresses questions of how best to distribute constrained resources to achieve maximum impact. Clinical research requires substantial financial and intellectual resources from industry, academia, foundations, and the federal government, along with the personal investment of thousands of patients with cancer.

Are modifications appropriate, and, if so, how and to what extent? The optimal collection of oncology trials is not known. However, some key themes have emerged from this work. First, we must ensure that the ClinicalTrials. Second, there is a need for a more nuanced approach to clinical trial design.

Although open, single-arm, nonrandomized trials that rely on historical controls are appropriate for some cancer types and settings, it is difficult to argue that they should be the norm, especially as more agents enter the market. The lack of variation in design by funding status and cancer type is of particular interest. One might anticipate that cancer types with more developed treatment paradigms, longer overall survival, and government trials would be more likely to have clinical trials that are blinded, later-phase, and larger, but this association was not consistently seen in the data.

There should be a regulatory push to match the trial design to the indication and to identify appropriate transition points in the drug development process when trial designs should mature in line with changes in survival by tumor type. Attributes of clinical trials for a given cancer type should evolve in areas such as phase and size to ensure that research reflects the state of the treatment landscape and of the science. Unfortunately, there is no normative standard because the clinical research needs in areas such as cardiology or orthopedic surgery differ from those in oncology owing to the acuity of the disease and the quickly evolving treatment paradigm.

The first step in moving the field forward is to use the curated AACT database to elucidate critical attributes of existing trials. Our vision is to then use it to monitor ongoing clinical research, maximizing its impact through a consortium of sponsors, researchers, policymakers, and advocacy organizations. Metrics must be developed that reflect a thoughtful balance between competing priorities. To date, however, attempts by the project team to develop metrics have been stymied, in part because of the poor reporting standards referenced earlier.

Metrics should not be developed in a vacuum, because critical data are needed to inform the agenda, such as the accrual success of different trial designs and the choice of appropriate end points. For instance, advocating for new trial networks and increased randomization would be inappropriate if doing so would undermine accrual to trials. The project team has found it to be difficult to gather critical data on both ongoing and completed trials, such as accrual rates, despite coupling publicly available data with direct-to-investigator surveys.

The rate of negative results that go unpublished further complicates analytic efforts.