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Page 1
Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials.
Seeger JD, Davis KJ, Iannacone MR, Zhou W, Dreyer N, Winterstein AG, Santanello N, Gertz B, Berlin JA. Seeger JD, et al. Among authors: berlin ja. Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1382-1392. doi: 10.1002/pds.5141. Epub 2020 Oct 4. Pharmacoepidemiol Drug Saf. 2020. PMID: 32964514 Free PMC article. Review.
These internal controls are missing in single arm trials and from long-term extensions (LTE) of trials including only the treatment arm. ...
These internal controls are missing in single arm trials and from long-term extensions (LTE) of trials including only the treatment a …
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR.
Bissonnette R, Gottlieb AB, Langley RG, Leonardi CL, Papp KA, Pariser DM, Uy J, Lafferty KP, Langholff W, Fakharzadeh S, Berlin JA, Brouwer ES, Greenspan AJ, Strober BE. Bissonnette R, et al. Among authors: berlin ja. Drug Saf. 2021 Jun;44(6):699-709. doi: 10.1007/s40264-021-01065-z. Epub 2021 Jun 2. Drug Saf. 2021. PMID: 34075572 Free PMC article. Review.
OBJECTIVE: The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using learnings from analyses of a potential safety risk for major adverse cardiovascular events (MACE) in PSOLAR. ...CONCLUSION: Our results, wh …
OBJECTIVE: The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using …
Effects of L-carnitine on dialysis-related hypotension and muscle cramps: a meta-analysis.
Lynch KE, Feldman HI, Berlin JA, Flory J, Rowan CG, Brunelli SM. Lynch KE, et al. Among authors: berlin ja. Am J Kidney Dis. 2008 Nov;52(5):962-71. doi: 10.1053/j.ajkd.2008.05.031. Epub 2008 Aug 15. Am J Kidney Dis. 2008. PMID: 18706751 Review.
SETTING & POPULATION: Adult patients with end-stage renal disease receiving long-term hemodialysis. SELECTION CRITERIA FOR STUDIES: All published English-language reports of randomized placebo-controlled trials of L-carnitine supplementation in adult long-term h …
SETTING & POPULATION: Adult patients with end-stage renal disease receiving long-term hemodialysis. SELECTION CRITERIA FOR STUDIE …
Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients.
Howard R, Costafreda SG, Karcher K, Coppola D, Berlin JA, Hough D. Howard R, et al. Among authors: berlin ja. Br J Psychiatry. 2016 Nov;209(5):378-384. doi: 10.1192/bjp.bp.115.177683. Epub 2016 Jul 7. Br J Psychiatry. 2016. PMID: 27388570 Review.
Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model with main effects for treatment and characteristic in addition to the interaction term. RESULTS: Baseline complications of depression ( …
Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model wi …
Uncontrolled Extensions of Clinical Trials and the Use of External Controls-Scoping Opportunities and Methods.
Wang CY, Berlin JA, Gertz B, Davis K, Li J, Dreyer NA, Zhou W, Seeger JD, Santanello N, Winterstein AG. Wang CY, et al. Among authors: berlin ja. Clin Pharmacol Ther. 2022 Jan;111(1):187-199. doi: 10.1002/cpt.2346. Epub 2021 Aug 10. Clin Pharmacol Ther. 2022. PMID: 34165790 Free PMC article.
Increased interest in real-world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long-term benefits and risks of pharmaceutical products raise the importance of understanding the use of external controls (ECs) for uncontrolled extensions …
Increased interest in real-world evidence (RWE) for clinical and regulatory decision making and the need to evaluate long-term benefi …
Risk of breast cancer associated with short-term use of oral contraceptives.
Folger SG, Marchbanks PA, McDonald JA, Bernstein L, Ursin G, Berlin JA, Daling JR, Norman SA, Strom BL, Weiss LK, Simon MS, Burkman RT, Malone KE, Spirtas R. Folger SG, et al. Among authors: berlin ja. Cancer Causes Control. 2007 Mar;18(2):189-98. doi: 10.1007/s10552-006-0086-7. Epub 2007 Jan 10. Cancer Causes Control. 2007. PMID: 17216547
OBJECTIVE: To estimate breast cancer risk associated with short-term (<6 months) oral contraceptive use, and explore variation in estimates by use characteristics and medical, menstrual, and reproductive history. ...However, significant interaction between short-term …
OBJECTIVE: To estimate breast cancer risk associated with short-term (<6 months) oral contraceptive use, and explore variation in …
The effect of selective serotonin re-uptake inhibitors on the risk of myocardial infarction in a cohort of patients with depression.
Kimmel SE, Schelleman H, Berlin JA, Oslin DW, Weinstein RB, Kinman JL, Sauer WH, Lewis JD. Kimmel SE, et al. Among authors: berlin ja. Br J Clin Pharmacol. 2011 Sep;72(3):514-7. doi: 10.1111/j.1365-2125.2011.04008.x. Br J Clin Pharmacol. 2011. PMID: 21557758 Free PMC article.
RESULTS: SSRI exposure may be associated with a reduced MI risk (OR = 0.77, 95% CI 0.57, 1.03). However, reduced risk was only observed with longer term use (OR = 0.73, 95% CI 0.53, 1.00) and not with shorter term use (OR = 1.15, 95% CI: 0.65, 2.05). CONCLUSIONS: On …
RESULTS: SSRI exposure may be associated with a reduced MI risk (OR = 0.77, 95% CI 0.57, 1.03). However, reduced risk was only observed with …
Hormone replacement therapy regimens and breast cancer risk(1).
Weiss LK, Burkman RT, Cushing-Haugen KL, Voigt LF, Simon MS, Daling JR, Norman SA, Bernstein L, Ursin G, Marchbanks PA, Strom BL, Berlin JA, Weber AL, Doody DR, Wingo PA, McDonald JA, Malone KE, Folger SG, Spirtas R. Weiss LK, et al. Among authors: berlin ja. Obstet Gynecol. 2002 Dec;100(6):1148-58. doi: 10.1016/s0029-7844(02)02502-4. Obstet Gynecol. 2002. PMID: 12468157
Hormone replacement therapy (HRT) has increased in the United States over the past 2 decades in response to reports of long-term health benefits. A relationship between HRT and breast cancer risk has been observed in a number of epidemiological studies. ...Our data suggest …
Hormone replacement therapy (HRT) has increased in the United States over the past 2 decades in response to reports of long-term heal …
Association between complete response and outcomes in transplant-eligible myeloma patients in the era of novel agents.
van de Velde H, Londhe A, Ataman O, Johns HL, Hill S, Landers E, Berlin JA. van de Velde H, et al. Among authors: berlin ja. Eur J Haematol. 2017 Mar;98(3):269-279. doi: 10.1111/ejh.12829. Epub 2016 Dec 17. Eur J Haematol. 2017. PMID: 27859769
METHODS: A total of 24 studies in newly diagnosed patients undergoing autologous stem cell transplantation (ASCT) that reported associations between responses and long-term outcomes (PFS/OS rates post-ASCT by response, or hazard ratios with 95% confidence intervals from Co …
METHODS: A total of 24 studies in newly diagnosed patients undergoing autologous stem cell transplantation (ASCT) that reported associations …
Intellectual outcome in children with maple syrup urine disease.
Kaplan P, Mazur A, Field M, Berlin JA, Berry GT, Heidenreich R, Yudkoff M, Segal S. Kaplan P, et al. Among authors: berlin ja. J Pediatr. 1991 Jul;119(1 Pt 1):46-50. doi: 10.1016/s0022-3476(05)81037-6. J Pediatr. 1991. PMID: 2066858 Free article.
Multiple regression analysis indicated that the important influences on IQ were age at the time of diagnosis and long-term metabolic control; control at the time of testing also might have affected performance. ...
Multiple regression analysis indicated that the important influences on IQ were age at the time of diagnosis and long-term metabolic …
22 results