Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors.

1983 ◽  
Vol 1 (2) ◽  
pp. 164-169 ◽  
Author(s):  
M Zelen
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Study Design ◽  
Journal Editor ◽  
Cancer Clinical Trials ◽  
Journal Editors ◽  
Early Results ◽  
Published Paper ◽  
Statistical Results

Guidelines are proposed for the reporting of clinical trials. These are meant to be used for both authors and journal editors. Specific proposals are made for: reporting the population under study, actual therapy used, describing the study design, accounting of patients, follow-up statistics, and describing the quality control of the data. Nonrandomized studies require special discussion. Such studies potentially have substantial biases which can lead to incorrect conclusions. Six areas of biases arising in nonrandomized studies are pointed out which should require a discussion in an acceptable published paper. The presentation of statistical results and the reporting of early studies present unusually difficult problems. Guidelines are presented for statistical analyses which, although simple to implement in practice, are not generally used. A proposal is made for the publication of early results of a study which require that the authors agree to follow and periodically report on their trial to the journal editor. If the early conclusions change with additional follow-up, the editor should notify its readers. The adoption of these guidelines can be an important force in raising the scientific level of the reporting of clinical trials.

Appropriate endpoints for superficial bladder cancer clinical trials.

1987 ◽  
Vol 5 (12) ◽  
pp. 2004-2008 ◽  
Author(s):  
L A Kalish ◽  
M B Garnick ◽  
J P Richie
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Clinical Outcome ◽  
Superficial Bladder Cancer ◽  
Invasive Disease ◽  
Actual Data ◽  
Cancer Clinical Trials ◽  
Data Sets ◽  
End Points

Many protocols for treatment of superficial bladder cancer include periodic cystoscopic examinations with resection of visible lesions. This allows pathological restaging of the disease at each examination. For example, this type of follow-up is common in clinical trials evaluating intravesical therapies. In such trials, clinical outcome is typically summarized using end-points that measure failure to control superficial disease. Alternative endpoints measuring failure to prevent progression to invasive disease are often ignored. In this report, the rationale for ignoring the invasive disease endpoints is given and flaws in the rationale are described. Evidence from actual data sets support the view that superficial disease endpoints may not be appropriate surrogates for invasive disease endpoints. It is recommended that time to invasive disease should be considered a major endpoint when designing and analyzing trials in superficial bladder cancer.

scholarly journals Evaluating follow-up and complexity in cancer clinical trials (EFACCT): an eDelphi study of research professionals’ perspectives

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034269
Author(s):  
Helene Markham Jones ◽  
Ffion Curtis ◽  
Graham Law ◽  
Christopher Bridle ◽  
Dorothy Boyle ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Online Survey ◽  
Assessment Tool ◽  
Cancer Clinical Trials ◽  
Consensus Methods ◽  
Care Hospital ◽  
Eligibility Criteria ◽  
Consensus Statements ◽  
Research Professionals

ObjectivesTo evaluate patient follow-up and complexity in cancer clinical trial delivery, using consensus methods to: (1) identify research professionals’ priorities, (2) understand localised challenges, (3) define study complexity and workloads supporting the development of a trial rating and complexity assessment tool (TRACAT).DesignA classic eDelphi completed in three rounds, conducted as the launch study to a multiphase national project (evaluating follow-up and complexity in cancer clinical trials).SettingMulticentre online survey involving professionals at National Health Service secondary care hospital sites in Scotland and England varied in scale, geographical location and patient populations.ParticipantsPrincipal investigators at 13 hospitals across nine clinical research networks recruited 33 participants using pre-defined eligibility criteria to form a multidisciplinary panel.Main outcome measuresStatements achieving a consensus level of 70% on a 7-point Likert-type scale and ranked trial rating indicators (TRIs) developed by research professionals.ResultsThe panel developed 75 consensus statements illustrating factors contributing to complexity, follow-up intensity and operational performance in trial delivery, and specified 14 ranked TRIs. Seven open questions in the first qualitative round generated 531 individual statements. Iterative survey rounds returned rates of 82%, 82% and 93%.ConclusionsClinical trials operate within a dynamic, complex healthcare and innovation system where rapid scientific advances present opportunities and challenges for delivery organisations and professionals. Panellists highlighted cultural and organisational factors limiting the profession’s potential to support growing trial complexity and patient follow-up. Enhanced communication, interoperability, funding and capacity have emerged as key priorities. Future operational models should test dialectic Singerian-based approaches respecting open dialogue and shared values. Research capacity building should prioritise innovative, collaborative approaches embedding validated review and evaluation models to understand changing operational needs and challenges. TRACAT provides a mechanism for continual knowledge assimilation to improve decision-making.

scholarly journals Association Between Disease-Free Survival and Overall Survival When Survival Is Prolonged After Recurrence in Patients Receiving Cytotoxic Adjuvant Therapy for Colon Cancer: Simulations Based on the 20,800 Patient ACCENT Data Set

2010 ◽  
Vol 28 (3) ◽  
pp. 460-465 ◽  
Author(s):  
Aimery de Gramont ◽  
Joleen Hubbard ◽  
Qian Shi ◽  
Michael J. O'Connell ◽  
Marc Buyse ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Disease Free Survival ◽  
Cancer Clinical Trials ◽  
Data Set ◽  
Free Survival ◽  
Disease Free ◽  
Extended Survival

Purpose We previously validated disease-free survival (DFS) as a surrogate for overall survival (OS) in fluorouracil-based adjuvant colon cancer clinical trials. New therapies have extended survival after recurrence from 1 to approximately 2 years. We examined the possible impact of this improvement on the DFS/OS association. Methods The Adjuvant Colon Cancer Endpoints (ACCENT) data set of 20,898 patients was analyzed. In an exploratory fashion, time from recurrence to death in patients experiencing recurrence was extended using several algorithms, and the association of DFS after 3 years of median follow-up and OS after varying lengths of follow-up (median of 5, 6, and 7 years) was assessed. Results Seven thousand four hundred two patients (35%) experienced recurrence. Median time from recurrence to death was 24 months in the hypothetical data sets. When times from recurrence to death were doubled, the association between treatment effects on DFS and 5-year OS was modest (R2 = 0.51 for both 2- and 3-year DFS) but remained strong for DFS and 6-year OS (R2 = 0.67 for both 2- and 3-year DFS) and 7-year OS (R2 = 0.70 for both 2- and 3-year DFS). The reduced DFS/OS association with extended survival after recurrence was greater in stage II than stage III patients. Multiple simulations provided consistent findings. Conclusion Extended survival after recurrence reduces the association between treatment effects on 3-year DFS and 5-year OS, particularly in stage II patients; longer follow-up strengthens the association. In modern adjuvant trials, 6 or 7 years may be required to demonstrate OS improvements, further supporting DFS as the preferred primary end point for future adjuvant colon cancer clinical trials.

scholarly journals On clinical trial fragility due to patients lost to follow up

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin R. Baer ◽  
Stephen E. Fremes ◽  
Mario Gaudino ◽  
Mary Charlson ◽  
Martin T. Wells
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Intermediate State ◽  
Statistical Tests ◽  
Statistical Significance ◽  
Artery Bypass ◽  
Fragility Index ◽  
Lost To Follow Up ◽  
Statistical Results

Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.

SU-E-T-718: Automatic IMRT Plan Quality Control for GYN Cancer Clinical Trials

2013 ◽  
Vol 40 (6Part22) ◽  
pp. 371-371
Author(s):  
T Song ◽  
N Li ◽  
Y Graves ◽  
Q Gautier ◽  
M Zarepisheh ◽  
...  
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Imrt Plan ◽  
Plan Quality

scholarly journals A unified approach to permutation testing for equivalence

2020 ◽  
Author(s):  
Rosa Arboretti ◽  
Fortunato Pesarin ◽  
Luigi Salmaso
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Comparative Analysis ◽  
Null Hypothesis ◽  
Mirror Image ◽  
Permutation Testing ◽  
Unified Approach ◽  
Published Paper

AbstractThe notion of testing for equivalence of two treatments is widely used in clinical trials, pharmaceutical experiments, bioequivalence and quality control. It is traditionally operated within the intersection–union principle (IU). According to this principle the null hypothesis is stated as the set of effects the differences $$\delta$$ δ of which lie outside a suitable equivalence interval and the alternative as the set of $$\delta$$ δ that lie inside it. In the literature related solutions are essentially based on likelihood techniques, which in turn are rather difficult to deal with. A recently published paper goes beyond most of likelihood limitations by using the IU approach within the permutation theory. One more paper, based on Roy’s union–intersection principle (UI) within the permutation theory, goes beyond some limitations of traditional two-sided tests. Such UI approach, effectively a mirror image of IU, assumes a null hypothesis where $$\delta$$ δ lies inside the equivalence interval and an alternative where it lies outside. Since testing for equivalence can rationally be analyzed by both principles but, as the two differ in terms of the mirror-like roles assigned to the hypotheses under study, they are not strictly comparable. The present paper’s main goal is to look into these problems and provide a sort of comparative analysis of both by highlighting the related requirements, properties, limitations, difficulties, and pitfalls so as to get practitioners properly acquainted with their correct use in practical contexts.

Attitudes of patients towards cancer clinical trials.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 741-741
Author(s):  
Olubukola Ayodele ◽  
Mateen Akhtar ◽  
Mathew Chad Eastwood ◽  
Aiste Linkeviciute-Koneko ◽  
Niamh M. Keegan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
University Hospital ◽  
Cancer Clinical Trials ◽  
Summary Statistics ◽  
Test Results ◽  
Exact Test ◽  
Patient Awareness ◽  
New Drug ◽  
New Treatment

741 Background: Older patients (pts) with cancer are under-represented in clinical trials (CTs). To better understand the causes for low accrual rates, the pts perspective must be explored. Objectives: To determine the attitudes of Irish pts towards enrolment into cancer CTs and in particular, the differences between the attitudes of older and younger pts. Methods: Pts with a gastrointestinal cancer, receiving treatment or in follow-up in University Hospital Waterford were eligible. Pts completed a self-dministered questionnaire comprising three sections: attitudes towards CT participation, reasons to participate, and reasons to decline participation. Pts were given three CT scenarios and were asked if they would participate: these included a cancer prevention/screening CT; a CT comparing standard to new treatment and a trial of a new drug where no standard exists. Summary statistics were used to describe the respondents. Differences between the groups were investigated using the Fishers exact test. Results: From March 2014, 69 pts were accrued, 31 <65 yrs (32-64) and 38 ≥65 yrs (65–85). Five (16%) younger and 3 (8%) older pts had been or were actively enrolled on a CT (p=0.45). An additional 4 (17%) younger and 5 (13%) older pts were invited to participate in a CT, all of whom declined. No patient in either group had actively enquired about CT availability. For the CT scenarios, 22 (71%) younger vs. 22 (58%) older pts would participate in a prevention/screening CT (p=0.32); 14 (45%) vs. 19 (50%) for standard vs. new drug CT (p=0.81), and 23 (74%) vs. 31 (82%) for a CT where no standard exists (p=0.56). The most common reasons to participate in a CT included the potential to feel better, reported in 100% of younger and older pts, the potential to live longer (100% vs. 92%) and the potential to help others (97% vs 89%). Age was deemed an important consideration in 20 (65%) younger and 25 (66%) older pts. Conclusions: The attitudes of older and younger pts to cancer CTs are similar. Physician barriers and availability of appropriate studies impact accrual of both older and younger cancer pts into trials. No patient in this study actively sought out a CT, suggesting a need for better patient awareness and education. This study is ongoing and updated results will be presented.

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