Drug cost savings in phase III hematological oncology clinical trials in a university hospital

2020 ◽  
Vol 38 (4) ◽  
pp. 576-583
Author(s):  
Chloé Herledan ◽  
Florence Ranchon ◽  
Vérane Schwiertz ◽  
Amandine Baudouin ◽  
Lionel Karlin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Cost ◽  
Cost Savings ◽  
University Hospital ◽  
Phase Iii ◽  
Oncology Clinical Trials

Trends in the content and format of main and optional consent forms in oncology clinical trials.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 153-153
Author(s):  
Sonja Rummell ◽  
Leo Chen ◽  
Winson Y. Cheung
Keyword(s):  
Clinical Trials ◽  
Reading Level ◽  
Phase Iii ◽  
Cancer Center ◽  
Consent Forms ◽  
Flesch Reading Ease ◽  
Gi Cancer ◽  
Oncology Clinical Trials ◽  
Cancer Studies ◽  
Over Time

153 Background: Informed consent forms (ICFs) should provide prospective subjects with an opportunity to balance the risks and benefits of study participation. However, there are growing concerns about the quality of ICFs. Optional ICFs are also increasingly used as the number of companion studies and biomarker evaluations requiring additional tests become more frequent. We examined trends in the content and format of main and optional ICFs. Methods: ICFs from clinical trials at a tertiary cancer center in British Columbia from 2000 to 2015 were reviewed. We focused on breast or gastrointestinal (GI) cancer studies. Readability was evaluated with the Flesch Reading Ease Score (FRES) and Flesch Kincaid Grade Level (FKGL) where a higher FRES (maximum 100) and a lower FKGL (maximum 12) indicated easier readability. We applied t-tests and linear regressions to examine variations among clinical trials and changes over time. Results: We identified 133 main ICFs of which 70% had optional ICFs and where 57% and 43% were breast and GI cancer studies. Phase III trials (44%), industry funded investigations (70%), and studies involving palliative therapies (72%) were most common. Trials from recent years were more likely to have optional ICFs than those from earlier years (p < 0.001). The median length and median word count in main and optional ICFs were 16 and 6 pages and 6183 and 1862 words, respectively. These changed significantly over time whereby main ICFs increased approximately by 1 page and 364 words per year over the 15 year period (p < 0.001). Industry funded trials also had longer ICFs (p = 0.006). Study methods, risks, and confidentiality occupied 29%, 20%, and 11% of the content on ICFs, respectively. Sections pertaining to eligibility (p < 0.001) and screening procedures (p = 0.007) also increased with time, particularly for industry funded studies (p = 0.006). In terms of readability, optional ICFs were generally more difficult to read than main ICFs (FRES 48.3 vs 50.0, p = 0.024; FKGL 11.8 vs 11.1, p < 0.001), especially in recent years (p < 0.001). Conclusions: This is one of the first analyses to include optional ICFs. Length of ICFs is increasing and readability is discordant with the average reading level of potential trial participants.

scholarly journals Estimation of drug cost avoidance and pathology cost avoidance through participation in NCIC Clinical Trials Group phase III clinical trials in Canada

2016 ◽  
Vol 23 (0) ◽  
pp. 7 ◽  
Author(s):  
P.A. Tang ◽  
A.E. Hay ◽  
C.J. O’Callaghan ◽  
N. Mittmann ◽  
C.R. Chambers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Cost ◽  
Phase Iii ◽  
Cost Avoidance ◽  
Phase Iii Clinical Trials

Tailored endpoints: A proposal for design of future clinical trials in metastatic breast cancer (MBC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e13058-e13058
Author(s):  
Caterina Fontanella ◽  
Marta Bonotto ◽  
Pamela Driol ◽  
Francesca Valent ◽  
Lorenzo Gerratana ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Metastatic Breast ◽  
New Drugs ◽  
University Hospital ◽  
Phase Iii ◽  
Consecutive Series ◽  
First Line ◽  
Luminal A ◽  
Her2 Positive ◽  
Luminal B

e13058 Background: Widespread access to active agents against MBC has produced significant improvements in survival, even though few phase III trials are powered to detect overall survival (OS) effects. However, regulatory agencies hold OS as gold standard for approval of new drugs. OS can be portioned into the sum of progression-free survival (PFS) and survival post-progression (SPP). Recent data suggest that OS is a reasonable primary endpoint only when median SPP is short. On the other hand, patients enrolled in first-line trials could have a long life-expectancy. Aim of this study was to evaluate PFS, OS and SPP in a consecutive series of patients with MBC in order to obtain information as a basis for design of future clinical trials. Methods: Four hundred patients with MBC diagnosed from January 2004 to February 2011 at University Hospital of Udine, Italy, were included in the study. We examined the role of potential of disease and patients’ characteristics in influencing the different measures of outcome. Results: Median OS was 33.71 months (mo), in line with the best literature. Median PFS at first-line (PFS1) was 9.33 mo, with linear decrease at second (5.06), third (3.58), and fourth (3.19) line, respectively. Median SPP after first-line (SPP1) was 18.69 mo. Interestingly, differences in outcome were noticed according to immunophenotype. The best prognosis was observed in luminal A disease (OS= 46.72 mo, PFS1= 15.61 mo, SPP1= 25.43 mo). In luminal B disease, median OS was 27.66 mo, PFS1 8.94 mo, and SPP1 13.21 mo, respectively. In patients with HER2-positive disease, mainly treated with anti-HER2 therapy, outcome approached that of luminal A disease (OS= 41.10 mo, PFS= 9.89 mo, SPP1 18.69 mo). Patients with triple negative disease (TNBC) experienced the worst prognosis (OS= 8.54 mo, PFS1= 4.04 mo, SPP1= 2.83 mo). Conclusions: The study demonstrated different results in the measures of outcome according to the line of treatment and specific disease characteristics. As a consequence, endpoints of clinical trials should be tailored taking into consideration prognostic/predictive factors as well as the line of treatment.

Incremental Drug Treatment Cost in HIV-Positive Patients in Industry-Sponsored Clinical Trials

2008 ◽  
Vol 42 (11) ◽  
pp. 1586-1591 ◽  
Author(s):  
Rosario Santolaya Perrín ◽  
Fernando J García López
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Therapy ◽  
Cost Savings ◽  
Drug Costs ◽  
Extra Cost ◽  
University Hospital ◽  
Study Entry ◽  
The Cost ◽  
Mean Cost

Background: Drugs used in clinical trials supported by the pharmaceutical industry are supplied free of charge by the companies. However, maintenance of treatment with those drugs when the trials have finished can generate extra cost for patients who participated in the trials. Objective: To assess whether HIV-infected patients' participation in clinical trials results in drug cost savings or increases. Methods: An analysis of alt antiretrovirals dispensed to HIV-infected outpatients prior to, during, and after their participation in clinical trials in a university hospital during a 2-year period was conducted. Only patients who completed the trial during the study period were included. The following outcomes were measured: (1) cost saved (difference between cost per day during the trial and cost per day before study entry), (2) cost generated (difference between cost per day at the end of the trial and cost per day before study entry), (3) balance between cost saved and cost generated, and (4) number of days that a patient received a drug once the trial was finished to generate cost, considering costs saved. All data were extracted from the hospital pharmacy database. A stratified analysis by type of clinical trial (ordinary or expanded use) was undertaken. Results: Data from 61 patients were analyzed. The cost of drug therapy during patient participation in a clinical trial was lower than the cost prior to inclusion. Therefore, mean drug savings of $10.38 (US) per patient day resulted (95% CI –5.9 to 14.84), The mean cost generated was $8.74 per patient day (95% CI 3.95 to 13.52). Conclusions: A patient's participation in a clinical trial or expanded-access clinical trial generated extra cost once the trial had finished because the cost of drug therapy was higher at the end of the study. In our study, the daily drug costs saved during the trial were similar to the daily drug costs generated.

scholarly journals Real-world validity of randomized controlled phase III trials in newly diagnosed glioblastoma: to whom do the results of the trials apply?

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Erlend Skaga ◽  
Marthe Andrea Skretteberg ◽  
Tom Børge Johannesen ◽  
Petter Brandal ◽  
Einar O Vik-Mo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Performance Status ◽  
Geographical Area ◽  
Eastern Cooperative Oncology Group ◽  
University Hospital ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Eligibility Criteria ◽  
Phase Iii Trials

Abstract Background The survival rates in population-based series of glioblastoma (GBM) differ substantially from those reported in clinical trials. This discrepancy may be attributed to that patients recruited to trials tend to be younger with better performance status. However, the proportion and characteristics of the patients in a population considered either eligible or ineligible for trials is unknown. The generalizability of trial results is therefore also uncertain. Methods Using the Cancer Registry of Norway and the Brain Tumor Database at Oslo University Hospital, we tracked all patients within a well-defined geographical area with newly diagnosed GBM during the years 2012–2017. Based on data from these registries and the medical records, the patients were evaluated for trial eligibility according to criteria employed in recent phase III trials for GBM. Results We identified 512 patients. The median survival was 11.7 months. When we selected a potential trial population at the start of concurrent chemoradiotherapy (radiotherapy [RT]/ temozolomide [TMZ]) by the parameters age (18–70 y), passed surgery for a supratentorial GBM, Eastern Cooperative Oncology Group (ECOG) ≤2, normal hematologic, hepatic and renal function, and lack of severe comorbidity, 57% of the patients were excluded. Further filtering the patients who progressed during RT/TMZ and never completed RT/TMZ resulted in exclusion of 59% and 63% of the patients, respectively. The survival of patients potentially eligible for trials was significantly higher than of the patients not fulfilling trial eligibility criteria (P &lt; .0001). Conclusions Patients considered eligible for phase III clinical trials represent a highly selected minority of patients in a real-world GBM population.

scholarly journals Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

2021 ◽  
Vol 13 ◽  
pp. 175883592110011
Author(s):  
Ramez N. Eskander ◽  
Matthew A. Powell
Keyword(s):  
Clinical Trials ◽  
Endometrial Cancer ◽  
Standard Of Care ◽  
Phase Iii ◽  
Oncologic Outcomes ◽  
Current Phase ◽  
Advanced Stage ◽  
Cancer Review ◽  
Oncology Clinical Trials ◽  
Recurrent Endometrial Cancer

The treatment of advanced stage, metastatic or recurrent endometrial cancer remains a clinically difficult scenario. Although combination carboplatin and paclitaxel is an effective standard-of-care regimen, alternate strategies have shown promise, particularly in biomarker select populations. In an effort to improve oncologic outcomes, investigators are exploring novel immunotherapy combinations. In this review, we discuss the clinical rationale and design of current phase III immuno-oncology clinical trials in patients with advanced stage or recurrent endometrial cancer.

Estimation of drug cost avoidance (DCA) and pathology cost avoidance (PCA) through participation in NCIC clinical trials group (NCIC-CTG) phase III clinical trials in Canada.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 6560-6560
Author(s):  
Patricia A. Tang ◽  
Annette E. Hay ◽  
Christopher J. O'Callaghan ◽  
Nicole Mittmann ◽  
Carole Chambers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Cost ◽  
Phase Iii ◽  
Cost Avoidance ◽  
Phase Iii Clinical Trials

scholarly journals Phase III Radiation Oncology Clinical Trials: A Snapshot of the Last Two Decades

2020 ◽  
Vol 108 (3) ◽  
pp. e788-e789
Author(s):  
R. Kouzy ◽  
J. Abi Jaoude ◽  
M.B. El Alam ◽  
W. Mainwaring ◽  
T.A. Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Radiation Oncology ◽  
Phase Iii ◽  
Oncology Clinical Trials
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