Increasing the Number of Clinical Trials Available to Adolescents Diagnosed With Cancer

Gupta, Abha; Indelicato, Daniel J.

doi:10.1542/peds.2014-0122g

Cited by 15 publications

(25 citation statements)

References 11 publications

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“…What is clearly ominous, therefore, is the decline in treatment trial accruals since 2000 in older AYAs. The extra effort that has been expended successfully on increasing the clinical trial participation of adolescents with cancer and has apparently been successful should be extended to young adults. Reasons for the decline are undoubtedly multifactorial but likely include reorganization of the NCI cooperative group structure, function, and reimbursement that by 2000 was under development and by 2014 was replaced with the NCTN.…”

Section: Discussionmentioning

confidence: 99%

“…Table is a summary of recommendations that can potentially improve accrual of AYAs to treatment trials. Most of these have been proffered in prior publications and discussed at workshops . It is time to pursue these suggestions more vigorously in order to accomplish in older AYAs what has recently been successful in 15–19 year olds with cancer and in children with cancer before that and in whom virtually all progress emanated from research.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

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Role of clinical trials in survival progress of American adolescents and young adults with cancer—and lack thereof

Bleyer

Tai²,

Siegel

2018

Pediatric Blood & Cancer

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In the United States, adolescent and young adult (AYA) patients with cancer have the lowest clinical trial participation rate of all age groups and slower progress in survival improvement than younger patients. Ominously, AYA clinical trial participation has been steadily decreasing since 2010, except in 15–19 year olds and AYAs with acute lymphoblastic leukemia. In order to reverse the accrual trend, multiple changes are necessary, including convincing community oncologists to pursue clinical trials on behalf of their AYA patients and to have the new National Community Oncology Research Program and National Clinical Trials Network lead a coordinated effort to increase accrual.

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Section: Discussionmentioning

confidence: 99%

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Role of clinical trials in survival progress of American adolescents and young adults with cancer—and lack thereof

Bleyer

Tai²,

Siegel

2018

Pediatric Blood & Cancer

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“…Regulatory issues are a barrier to recruitment due to the logistics associated with gaining regulatory approval in multiple organisations and may deter centres from opening trials when small numbers are expected to be recruited . Weiss et al .…”

Section: Resultsmentioning

confidence: 99%

Enhancing accrual to clinical trials of adolescents and young adults with cancer

Fern

Taylor

2018

Pediatric Blood & Cancer

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Underrepresentation of young people in cancer research is an international phenomenon and may contribute to poorer outcomes. We sought to identify systematically tested interventions and strategies to improve recruitment. The review identified 13 papers. The following four themes emerged: trial availability/regulatory factors; service configuration/place-of-care factors; recruitment methods and developmental factors specific to young people. We could not identify any studies that had employed prospective interventions to improve recruitment. Without available research studies in which to garner data on adolescents and young adults, we will always be constrained in our ability to provide evidence based care with resultant limitations on our ability to improve outcomes.

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“…The logistic concerns include the location of care for the adolescent patients and require increased cooperation between pediatric and medical oncologists (and their respective institutions) who may not be in the same geographic location (5, 21, 22). Revising age eligibility criteria would also allow for the enrollment of adolescents on relevant clinical trials when they are managed outside of a pediatric setting.…”

Section: Potential Barriersmentioning

confidence: 99%

Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents

Chuk

Mulugeta

Roth-Cline

et al. 2017

Clinical Cancer Research

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The enrollment of adolescents with cancer in clinical trials is much lower than younger pediatric patients. For adolescents with “adult-type” cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment on adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data is lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies. In order to facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) on disease and target-appropriate adult oncology trials. This approach requires careful monitoring for any differential safety signals, appropriate pharmacokinetic evaluations, and ensuring that ethical requirements are met. Inclusion of adolescents on adult oncology trials will require the cooperation of investigators, cooperative groups, industry, IRBs, and regulatory agencies to overcome real and perceived barriers.

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Increasing the Number of Clinical Trials Available to Adolescents Diagnosed With Cancer

Cited by 15 publications

References 11 publications

Role of clinical trials in survival progress of American adolescents and young adults with cancer—and lack thereof

Role of clinical trials in survival progress of American adolescents and young adults with cancer—and lack thereof

Enhancing accrual to clinical trials of adolescents and young adults with cancer

Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents

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