scholarly journals Pharmacogenetic Implementation In The Routine Clinical Practice: Design of A Multicenter Pilot Clinical Trial

2015 ◽  
Vol 37 (8) ◽  
pp. e129-e130
Author(s):  
A.M. Borobia ◽  
R. Lubomirov ◽  
F. Abad ◽  
H.Y. Tong ◽  
E. Ramírez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Routine Clinical Practice

A review of the patterns of docetaxel use for hormone refractory prostate cancer (HRPC) at the Princess Margaret Hospital

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16161-e16161
Author(s):  
S. N. Chin ◽  
L. Wang ◽  
A. Lau ◽  
M. Moore ◽  
S. S. Sridhar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Median Duration ◽  
Response Rates ◽  
Routine Clinical Practice ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
First Line

e16161 Background: Docetaxel is standard of care for the treatment of HRPC, based on two large randomized clinical trials. The aim of this study was to determine if docetaxel use and effectiveness in routine clinical practice was similar to that seen in the TAX 327 randomized phase III clinical trial. Methods: A retrospective chart review was undertaken to assess patterns of docetaxel use for HRPC at our institution for the 2-year period since its approval for the first-line treatment of HRPC in 2005. Results: Eighty-eight patients, median age 71 and baseline PSA 107, received docetaxel in the first line setting. Main reasons for initiating docetaxel were rising PSA (90%) and progressive symptoms (71%). Eighteen percent of patients received docetaxel for rising PSA alone. A median of 7 cycles was administered. PSA response rates were 61%, time to response 1.5 months, and response duration 6.8 months. Disease progression was the most common reason for treatment discontinuation (36%). Main toxicities were fatigue (32%) and neuropathy (22%). Kaplan Meier survival analysis showed median duration of survival was 15.9 months (95% CI 12.4–20.5) from first drug use. 1-year survival was 0.63 (95% CI 0.52–0.72). Post-docetaxel, 36 patients received second-line treatment, mostly with mitoxantrone (89%). Second-line response rates were 22%, and median duration of response was 4 months. Conclusions: In routine clinical practice, docetaxel is a well-tolerated regimen for the treatment of HRPC. Response rates and toxicity profiles were comparable to the randomized trials. However, compared with the TAX 327 clinical trial, survival was slightly shorter than expected (15.9 vs. 18.9 months), possibly due to inclusion of patients with poorer performance status and comorbidities, who may be excluded from clinical trials. Second-line response rates were also comparable with previous reports. No significant financial relationships to disclose.

Assessing real-world clinical response in patients with multiple myeloma (MM): A survey of the literature.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19260-e19260
Author(s):  
Daniel Lane ◽  
Andrew D. Norden ◽  
Andrew J. Belli ◽  
Ching-Kun Wang
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Real World ◽  
English Language ◽  
Complete Response ◽  
Protein Electrophoresis ◽  
Mandatory Reporting ◽  
Routine Clinical Practice ◽  
Cell Transplant ◽  
Strict Adherence

e19260 Background: A recent study (Foster, Tromanhauser et al. 2019) utilizing Electronic Health Record (EHR) data found that patients with MM rarely have both serum protein electrophoresis (SPEP) and 24-hour urine protein electrophoresis (UPEP) documented in routine clinical practice settings. These elements are necessary to classify response using the International Myeloma Working Group (IMWG) consensus criteria. It could be hypothesized that adding the additional requirements for bone marrow biopsy necessary to confirm a complete response would further reduce the rate of strict adherence to the IMWG criteria in the real world (RW). Clinicians are however assessing response and progression in RW settings and often report these assessments in published literature. In this study, we survey the literature to determine how RW response is being captured and reported outside of the clinical trial setting. Methods: A systematic search was performed using Medline 2010-2019. Using a standardized grading system, English language articles were evaluated that utilized EHR data from routine clinical practice to report RW response in patients with active MM. Registry based and/or pragmatic observational studies were excluded as many had mandatory reporting procedures in place. Studies were then categorized based on methods of assessing response, progression and use of IMWG criteria. Results: The majority of studies grade 1 studies identified (21/25) utilized best response achieved based on treating physician-documented assessment and either did not specify the use of IMWG(10/21) criteria or explicitly stated they did not use conventional criteria (11/21). Progression event capture and reporting varied greatly with many using physician-documented progression, change in regimen, addition of additional agents to existing regimen, stem cell transplant, or an individually created algorithm. Conclusions: Our findings suggest that there is a need for further research on objective techniques for the assessment of RW progression and response in patients with MM. Additionally, validation of an approach that utilizes partial adherence to IMWG criteria would help in the ability to compare findings across clinical trial and RW settings. This validation work is under way, and preliminary results will be reported at the meeting.

Effect of proton pump inhibitors on the outcomes of peptic ulcer bleeding: comparison of event rates in routine clinical practice and a clinical trial

2013 ◽  
Vol 48 (3) ◽  
pp. 285-294 ◽  
Author(s):  
Angel Lanas ◽  
Mónica Polo-Tomas ◽  
Luis A. García-Rodríguez ◽  
Santiago García ◽  
María Teresa Arroyo-Villarino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peptic Ulcer ◽  
Clinical Practice ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Routine Clinical Practice ◽  
Ulcer Bleeding ◽  
Peptic Ulcer Bleeding ◽  
Event Rates

Translation of clinical trial data to changes in clinical practice: rapid transition from tenofovir disoproxil fumarate to tenofovir alafenamide-based therapies in a Sydney HIV clinic

2018 ◽  
Vol 29 (10) ◽  
pp. 1011-1013
Author(s):  
Don E Smith ◽  
Merrion Tom ◽  
Bruce H Bowden
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Antiviral Therapy ◽  
Tenofovir Disoproxil Fumarate ◽  
Clinical Trial Data ◽  
Routine Clinical Practice ◽  
Trial Data ◽  
Slow Process ◽  
Rapid Transition ◽  
Tenofovir Alafenamide

The transition of clinical trial data to changes in routine clinical practice is often a slow process. We describe a rapid transition of patients from one form of antiviral therapy to a modified and potentially safer version that can occur quickly when there are no financial or organisational restrictions on the prescribers.

Expectations in the Care of Lung Cancer

2015 ◽  
pp. e420-e424
Author(s):  
Rogerio Lilenbaum ◽  
Natasha B. Leighl ◽  
Marcus Neubauer
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Decision Making ◽  
Clinical Practice ◽  
Statistical Significance ◽  
Real Life ◽  
Clinical Trial Data ◽  
Routine Clinical Practice ◽  
Trial Data ◽  
Decision Making Process

One of the main challenges oncologists face in the care of patients with lung cancer is the decision to incorporate new clinical trial data into routine clinical practice. Beyond the question of statistical significance, which is a more objective metric, are the results meaningful and applicable to a broader population? Furthermore, in an era of value care, do the results justify a potential increase in costs? This article discusses the main points that clinicians consider in their decision-making process and illustrates the arguments with real-life examples.

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