scholarly journals Impact factor and citation metrics in phase III cancer trials

Oncotarget ◽  
2021 ◽  
Author(s):  
Joseph Abi Jaoude ◽  
Ramez Kouzy ◽  
Michael Rooney ◽  
Petria Thompson ◽  
Roshal Patel ◽  
...  
Keyword(s):  
Impact Factor ◽  
Phase Iii ◽  
Cancer Trials ◽  
Citation Metrics

Units of measurement

2018 ◽  
Author(s):  
Gianfranco Pacchioni
Keyword(s):  
Impact Factor ◽  
Impact Factors ◽  
H Index ◽  
Units Of Measurement ◽  
Pros And Cons ◽  
Eugene Garfield ◽  
Citation Metrics

This chapter discusses how performance is measured in science, such as through the role of citation metrics. Next, the chapter discusses the pros and cons of bibliometric indexes, and of ‘impact factor’, which was introduced by Eugene Garfield in 1955 but not widely used until twenty years later. The various ways that journals attempt to improve their impact factors, and how this will affect science, are also examined. Besides impact factor, the role played by indicators in evaluating scientists, such as the recently introduced h-index, is explored. Finally, fashions and trends in science are touched upon, illustrated with personal anecdotes from the author.

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1515-1515
Author(s):  
John Stuart Peterson ◽  
Deborah Plana ◽  
Danielle Sara Bitterman ◽  
Skyler B Johnson ◽  
Benjamin Harris Kann
Keyword(s):  
Multivariable Analysis ◽  
Phase Iii ◽  
Word Count ◽  
Eligibility Criteria ◽  
Support Unit ◽  
National Priority ◽  
Clinical Trial Accrual ◽  
Unique Word ◽  
Cancer Trials ◽  
The Impact

1515 Background: Cancer clinical trial accrual across diverse socioeconomic and demographic groups is a national priority, yet up to 20% of trials fail due to poor accrual. Eligibility criteria content may contribute to poor accrual, but effects are challenging to measure. We sought to evaluate growth of eligibility criteria within NCI-affiliated cancer trials and the impact on trial accrual over the past decade. Methods: We conducted a retrospective study with the Aggregate Analysis of ClinicalTrials.gov (AACT) (abstracted: 02/02/2021). We included NCI-affiliated, interventional Phase II or III trials that initiated between 01/01/2008 and 12/13/2018. We excluded active and recruiting trials that lacked accrual data on the Cancer Trials Support Unit website. Trials whose status was “Withdrawn”, “Terminated”, or “Suspended” due to low accrual, or had less than 50% target accrual after two years active were deemed accrual failures. Eligibility criteria were extracted from inclusion and exclusion criteria and complexity was estimated by the number of unique content words, calculated by removing duplicates and stop words from the word count. Association of unique word count with accrual failure was evaluated by univariable and multivariable logistic regressions, adjusting for other predictors of low accrual identified in earlier research. Results: Of 1197 trials included, 231 (19.3%) failed due to low accrual. Eligibility criteria increased in length from a median of 214 (IQR [23, 282]) unique content words in 2008 to 417 (IQR [289, 514]) in 2018. The rate of trial accrual failure increased with unique word count decile from 11.8% in the first decile (12 to 112 words) to 29.4% in the tenth decile (445 to 750 words) (P = 0.004). On multivariable analysis, unique word count remained independently associated with low accrual (OR: 1.07 per decile, 95%CI [1.01-1.13], P = 0.02), as did Phase III and metastatic disease settings (Table). Conclusions: Eligibility criteria content has increased dramatically in the last decade in NCI-affiliated trials. Increasing eligibility criteria content associates strongly with accrual failure, even after adjusting for multiple known predictors of accrual. These findings underscore the need for efforts to simplify eligibility criteria to improve trial accrual. Further investigation is ongoing to determine specific criteria qualities that portend accrual failure.[Table: see text]

scholarly journals Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

2018 ◽  
Vol 36 (6) ◽  
pp. 563-571 ◽  
Author(s):  
Julie Lemieux ◽  
Michael D. Brundage ◽  
Wendy R. Parulekar ◽  
Paul E. Goss ◽  
James N. Ingle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aromatase Inhibitor ◽  
Short Form ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Change Scores ◽  
Sf 36 ◽  
Cancer Trials

Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

The influence of self-reported conflicts of interest on the conclusions of editorial authors of phase III cancer trials.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 6039-6039
Author(s):  
M. C. Miranda ◽  
A. T. Lera ◽  
A. Ueda ◽  
B. Briones ◽  
T. Lerner ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Phase Iii ◽  
Cancer Trials

Cancer clinical trial accessibility in the United States: An analysis of travel distance.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6540-6540
Author(s):  
Asma Latif ◽  
Kristian D Stensland ◽  
Ryan Hendricks ◽  
Erin L. Moshier ◽  
James H. Godbold ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
The United States ◽  
Travel Distance ◽  
Cancer Clinical Trial ◽  
Phase Iii ◽  
Tumor Type ◽  
Trial Site ◽  
Cancer Trials ◽  
Zip Code

6540 Background: Accessibility of cancer clinical trials has been cited as a barrier to participation. While there are several dimensions to accessibility, travel distance may represent an important measure with potential socio-demographic implications. We sought to identify the driving distance from each ZIP-code in the United States to the nearest clinical trial site for four common solid tumors, and correlate ZIP-code level demographics with travel distance. Methods: The ClinicalTrials.gov database was queried on September 12, 2012 to identify all open, actively recruiting phase II and phase III therapeutic interventional trials in first-line metastatic disease for the four most common solid tumor types in the United States (prostate, breast, lung, and colorectal). Driving distance from each ZIP-code in the continental United States to the nearest trial site for each tumor type was calculated. Trial sites located within the ZIP-code were set at a travel distance of 0 miles. ZIP-code level demographics, derived from the 2010 Census, were correlated with driving distance. Results: We identified 42 prostate cancer trials with 958 sites, 81 breast cancer trials with 1,345 sites, 83 lung cancer trials with 2,249 sites, and 32 colorectal cancer trials with 566 sites which met inclusion criteria. The travel distances for each tumor type are shown in the Table. Analyses correlating driving distance with ZIP-code level demographics are ongoing. Conclusions: Substantial heterogeneity exists regarding accessibility of cancer trials in the United States as measured by driving distance. The optimal geographic distribution of trials, the burden imposed by travel, and the degree to which travel distance contributes to poor cancer clinical trial enrollment all warrant further investigation. [Table: see text]

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