James Nickas | BioMarin - Academia.edu (original) (raw)

Papers by James Nickas

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

The Journal of Pediatrics, 1996

Research paper thumbnail of Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis”

Drug Information Journal, 1997

In recent years, many important initiatives have been undertaken by regulatory authorities and in... more In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory adverse event reporting requirements. Although harmonization of worldwide regulatory adverse event reporting requirements is a monumental achievement, developing safety surveillance guidelines that facilitate identification of the true safety profile of investigational products should be the focus of future harmonization efforts. This paper discusses and provides viewpoints on the “Fialuridine Crisis,” the Food and Drug Administration (FDA's) proposals to modify clinical trial safety surveillance requirements in the United States in response to the “Fialuridine Crisis,” and lessons learned. Thoughts on how to improve safety surveillance during clinical trials are presented.

Research paper thumbnail of Adverse Event Data Collection and Reporting: A Discussion of Two Grey Areas

Drug Information Journal, Oct 1, 1995

Research paper thumbnail of Drug Information for Physicians

Annals of Internal Medicine, 1985

Research paper thumbnail of Safety of Biotherapeutics

Principles and Practice, 2011

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

Journal of Pediatrics, 1996

As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor ... more As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor who were treated with growth hormone. The type of brain tumor was specified in 947 (75%) of these children. The most common types were glioma, medulloblastoma, and craniopharyngioma, accounting for 91.3% of all those for which the type was specified. Brain tumor recurred in 83 (6.6%) of the 1262 children over a total of 6115 patient-years at risk. The frequencies of tumor recurrence in children with low-grade gUoma (18.1%), medulloblastoma (7.2%), and craniopharyngioma (6.4%) are lower than those in published reports of tumor recurrence in the general pediatric population with the same types of tumors. The analysis cannot conclusively show that no increased risk of tumor recurrence exists, however, because of the potential incompleteness of data reporting in the National Cooperative Growth Study. Nevertheless the findings are reassuring that children with the more common types of brain tumor who are treated with growth hormone do not seem to be at excessive risk for tumor recurrence. (J Pediatr 1996;128:$4-7) Despite reports 1-8 that the recurrence of brain tumor is not markedly increased in children treated with growth hormone, physicians and parents of children with brain tumor continue to have concerns. That GH has been shown in animal studies to be mitogenic, 9, ~0 that GH and growth

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

Journal of Pediatrics, 1996

As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor ... more As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor who were treated with growth hormone. The type of brain tumor was specified in 947 (75%) of these children. The most common types were glioma, medulloblastoma, and craniopharyngioma, accounting for 91.3% of all those for which the type was specified. Brain tumor recurred in 83 (6.6%) of the 1262 children over a total of 6115 patient-years at risk. The frequencies of tumor recurrence in children with low-grade gUoma (18.1%), medulloblastoma (7.2%), and craniopharyngioma (6.4%) are lower than those in published reports of tumor recurrence in the general pediatric population with the same types of tumors. The analysis cannot conclusively show that no increased risk of tumor recurrence exists, however, because of the potential incompleteness of data reporting in the National Cooperative Growth Study. Nevertheless the findings are reassuring that children with the more common types of brain tumor who are treated with growth hormone do not seem to be at excessive risk for tumor recurrence. (J Pediatr 1996;128:$4-7) Despite reports 1-8 that the recurrence of brain tumor is not markedly increased in children treated with growth hormone, physicians and parents of children with brain tumor continue to have concerns. That GH has been shown in animal studies to be mitogenic, 9, ~0 that GH and growth

Research paper thumbnail of Adverse Event Data Collection and Reporting: A Discussion of Two Grey Areas

Drug Information Journal, 1995

Research paper thumbnail of Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis

Drug Information Journal, 1997

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

The Journal of Pediatrics, 1996

Research paper thumbnail of Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis”

Drug Information Journal, 1997

In recent years, many important initiatives have been undertaken by regulatory authorities and in... more In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory adverse event reporting requirements. Although harmonization of worldwide regulatory adverse event reporting requirements is a monumental achievement, developing safety surveillance guidelines that facilitate identification of the true safety profile of investigational products should be the focus of future harmonization efforts. This paper discusses and provides viewpoints on the “Fialuridine Crisis,” the Food and Drug Administration (FDA's) proposals to modify clinical trial safety surveillance requirements in the United States in response to the “Fialuridine Crisis,” and lessons learned. Thoughts on how to improve safety surveillance during clinical trials are presented.

Research paper thumbnail of Adverse Event Data Collection and Reporting: A Discussion of Two Grey Areas

Drug Information Journal, Oct 1, 1995

Research paper thumbnail of Drug Information for Physicians

Annals of Internal Medicine, 1985

Research paper thumbnail of Safety of Biotherapeutics

Principles and Practice, 2011

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

Journal of Pediatrics, 1996

As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor ... more As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor who were treated with growth hormone. The type of brain tumor was specified in 947 (75%) of these children. The most common types were glioma, medulloblastoma, and craniopharyngioma, accounting for 91.3% of all those for which the type was specified. Brain tumor recurred in 83 (6.6%) of the 1262 children over a total of 6115 patient-years at risk. The frequencies of tumor recurrence in children with low-grade gUoma (18.1%), medulloblastoma (7.2%), and craniopharyngioma (6.4%) are lower than those in published reports of tumor recurrence in the general pediatric population with the same types of tumors. The analysis cannot conclusively show that no increased risk of tumor recurrence exists, however, because of the potential incompleteness of data reporting in the National Cooperative Growth Study. Nevertheless the findings are reassuring that children with the more common types of brain tumor who are treated with growth hormone do not seem to be at excessive risk for tumor recurrence. (J Pediatr 1996;128:$4-7) Despite reports 1-8 that the recurrence of brain tumor is not markedly increased in children treated with growth hormone, physicians and parents of children with brain tumor continue to have concerns. That GH has been shown in animal studies to be mitogenic, 9, ~0 that GH and growth

Research paper thumbnail of Brain tumor recurrence in children treated with growth hormone: The National Cooperative Growth Study experience

Journal of Pediatrics, 1996

As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor ... more As of October 1993 the National Cooperative Growth Study included 1262 children with brain tumor who were treated with growth hormone. The type of brain tumor was specified in 947 (75%) of these children. The most common types were glioma, medulloblastoma, and craniopharyngioma, accounting for 91.3% of all those for which the type was specified. Brain tumor recurred in 83 (6.6%) of the 1262 children over a total of 6115 patient-years at risk. The frequencies of tumor recurrence in children with low-grade gUoma (18.1%), medulloblastoma (7.2%), and craniopharyngioma (6.4%) are lower than those in published reports of tumor recurrence in the general pediatric population with the same types of tumors. The analysis cannot conclusively show that no increased risk of tumor recurrence exists, however, because of the potential incompleteness of data reporting in the National Cooperative Growth Study. Nevertheless the findings are reassuring that children with the more common types of brain tumor who are treated with growth hormone do not seem to be at excessive risk for tumor recurrence. (J Pediatr 1996;128:$4-7) Despite reports 1-8 that the recurrence of brain tumor is not markedly increased in children treated with growth hormone, physicians and parents of children with brain tumor continue to have concerns. That GH has been shown in animal studies to be mitogenic, 9, ~0 that GH and growth

Research paper thumbnail of Adverse Event Data Collection and Reporting: A Discussion of Two Grey Areas

Drug Information Journal, 1995

Research paper thumbnail of Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis

Drug Information Journal, 1997