scholarly journals Innovations for phase I dose-finding designs in pediatric oncology clinical trials

2016 ◽  
Vol 47 ◽  
pp. 217-227 ◽  
Author(s):  
Adelaide Doussau ◽  
Birgit Geoerger ◽  
Irene Jiménez ◽  
Xavier Paoletti
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Pediatric Oncology ◽  
Dose Finding ◽  
Oncology Clinical Trials

Parental insights into phase I pediatric oncology clinical trials: Findings from a phenomenological study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21534-e21534
Author(s):  
Stacey Crane ◽  
James Croop ◽  
Jill Lunsford Lee ◽  
Jamie Walski ◽  
Joan Haase
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Childhood Cancer ◽  
Pediatric Oncology ◽  
Phenomenological Study ◽  
Medical Center ◽  
Well Being ◽  
Phase I Clinical Trials ◽  
Curative Therapy ◽  
Oncology Clinical Trials

e21534 Background: Phase I clinical trials (P1Ts) are an essential step in the validation of novel therapies to treat childhood cancer. Children with cancer participate in P1Ts when no known curative therapy remains for their cancer. It is important to understand the experiences of children with advanced cancer and their families in P1Ts to ensure that participation supports the participants’ well-being. Methods: An empirical phenomenology study, using an adapted Colaizzi method, was conducted of 11 parents’ lived experiences of their child’s participation in pediatric oncology P1Ts. Parents were recruited from two pediatric academic medical centers in the Midwest United States and from national childhood cancer groups not affiliated with either medical center. Parents participated in individual interviews (mean length 59.1 minutes), with one broad data-generating question. Demographics and the child’s clinical trial records provided additional context for understanding the experiences. This presentation describes the study themes identified that were specifically related to pediatric oncology P1T processes and logistics. Results: Parents’ experiences during the P1Ts were primarily positive. However, data analysis revealed five aspects of P1T participation that were problematic for parents to varying degrees. These aspects were: (1) Learning About Clinical Trials, (2) Being Referred to Another Institution, (3) Undergoing Research-Only Procedures, (4) Complying with the Trial Requirements, and (5) Taking Oral Medications. Conclusions: While overall experiences during P1T participation were positive, improvements can be made that could potentially enhance participants’ experiences. In particular, enhancing the education provided to participants during on-trial processes and minimizing the logistical burdens associated with P1T requirements may help to address problematic aspects of P1Ts.

scholarly journals Bayesian hybrid dose-finding design in phase I oncology clinical trials

2011 ◽  
Vol 30 (17) ◽  
pp. 2098-2108 ◽  
Author(s):  
Ying Yuan ◽  
Guosheng Yin
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Dose Finding ◽  
Oncology Clinical Trials

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

Perceptions of Phase I Clinical Trials in Pediatric Oncology Survey

2014 ◽  
Author(s):  
Margaux J. Barnes ◽  
Joseph Pressey ◽  
Julia Adams ◽  
Molly A. Hensler ◽  
Avi Madan-Swain
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Pediatric Oncology ◽  
Phase I Clinical Trials

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

Challenges in incentivizing the pharmaceutical industry to supporting pediatric oncology clinical trials

2013 ◽  
Vol 3 (2) ◽  
pp. 101-103 ◽  
Author(s):  
Paola Angelini ◽  
Kathryn Pritchard-Jones ◽  
Darren R Hargrave
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Pediatric Oncology ◽  
Oncology Clinical Trials
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