Abstract PR-09: Eligibility criteria perpetuate disparities in enrollment and participation in pancreatic cancer clinical trials

2022 ◽  
Author(s):  
Andrea N. Riner ◽  
Selamawit Girma ◽  
Nevena Skoro ◽  
Tamas S. Gal ◽  
Kelly M. Herremans ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria

Reducing patient eligibility criteria in cancer clinical trials.

1996 ◽  
Vol 14 (4) ◽  
pp. 1364-1370 ◽  
Author(s):  
S L George
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Eligibility Criterion ◽  
Cancer Clinical Trials ◽  
Recent Trial ◽  
Eligibility Criteria ◽  
Eligibility Requirements

PURPOSE To discuss patient eligibility criteria in phase III cancer clinical trials in the larger setting of the complexity of these trials, to review the various reasons for imposing restrictive eligibility requirements, to discuss the problems caused by these requirements, to argue that these requirements should be greatly relaxed in most cancer clinical trials, to provide some guiding principles and practical suggestions to facilitate such a relaxation, and to give an example of how eligibility requirements were reduced in a recent clinical trial in acute lymphocytic leukemia. METHODS Implicit and explicit reasons for including eligibility criteria in clinical trials are reviewed. Safety concerns and sample size issues receive special attention. The types of problems restrictive eligibility criteria cause with respect to scientific interpretation, medical applicability, complexity, costs, and patient accrual are described. RESULTS A list of three items that each eligibility criterion should meet in order to be included is proposed and applied to a recent trial in acute lymphocytic leukemia. CONCLUSION Phase III clinical trials in cancer should have much broader eligibility criteria than the traditionally restrictive criteria commonly used. Adoption of less restrictive eligibility criteria for most studies would allow broader generalizations, better mimic medical practice, reduce complexity and costs, and permit more rapid accrual without compromising patient safety or requiring major increases in sample size.

Optimization of miRNA profiling techniques for melanoma and pancreatic cancer clinical trials.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e22065-e22065
Author(s):  
Joseph Markowitz ◽  
Zachary Abrams ◽  
Naduparambil Jacob ◽  
Xiaoli Zhang ◽  
Nicholas Latchana ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Mirna Profiling ◽  
Profiling Techniques

Reappraisal of eligibility criteria in cancer clinical trials

2018 ◽  
Vol 30 (5) ◽  
pp. 352-357 ◽  
Author(s):  
Nicolas Penel ◽  
Loïc Lebellec ◽  
Marie Vanseymortier
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria

Eligibility criteria in haematological cancer clinical trials—what's needed?

2020 ◽  
Vol 7 (1) ◽  
pp. e10
Author(s):  
Mattia Calissano ◽  
Maria Beatrice Panico ◽  
Daniel J O'Connor
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
Haematological Cancer

scholarly journals Laboratory eligibility criteria as potential barriers to participation by black men in prostate cancer clinical trials.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 73-73
Author(s):  
Marie Vastola ◽  
David Dewei Yang ◽  
Brandon Arvin Virgil Mahal ◽  
Vinayak Muralidhar ◽  
Christopher S. Lathan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Renal Function ◽  
Black Men ◽  
Racial Differences ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
Black Patients ◽  
Incidence And Mortality

73 Background: Eligibility criteria may disproportionately affect black patients and contribute to their underrepresentation in clinical trials. We studied this potential barrier by examining clinical trials in prostate cancer, a disease in which black men face higher incidence and mortality. Specifically, we investigated the use of serum creatinine (sCr) alone instead of race-adjusted measurements for renal function, and the use of an absolute neutrophil count (ANC) threshold that could exclude men with benign ethnic neutropenia, which afflicts 6.7-8% of black patients and could lead to the exclusion of patients despite having healthy immune systems. Methods: We identified 401 interventional prostate cancer clinical trials with an overall survival endpoint. The list of trials was collected on January 16, 2017 from clinicaltrials.gov using the following criteria – study type: interventional studies; conditions: prostate cancer; interventions: drug; outcome measures: overall survival. Characteristics gathered from each trial included sponsor type, phase, accrual goal, start year, and toxicity. Results: Overall, 47.9% (192) of these trials used either sCr alone and/or required participants to have ANC ≥1.5×109 cells/L. Specifically, 25.2% (101) of the trials used sCr alone to determine eligibility, and 41.4% (166) of the trials required patients to have an ANC ≥1.5×109 cells/L. Conclusions: Of clinical trials in prostate cancer, 47.9% used criteria that disproportionately excluded black patients. The reevaluation of these two eligibility criteria could improve minority trial enrollment. First, lowering the ANC cutoff for patients with benign ethnic neutropenia would increase the number of eligible black participants, as 89% of these patients have an ANC ≥1.0×109 cells/L. Second, using race-adjusted equations for renal function would take into account racial differences in creatinine. While adopting race-based differences in trial criteria may add slight logistical challenges when ensuring patients meet trial eligibility, these adjustments would prevent healthy patients from being excluded solely because of benign laboratory differences caused by their race.

Evaluation of factors associated with recruitment in hematological clinical trials: A retrospective study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6567-6567
Author(s):  
C. Amireault ◽  
S. Camden ◽  
J. Poulin ◽  
J. Lemieux
Keyword(s):  
Clinical Trials ◽  
Stage Iv ◽  
Quebec City ◽  
Cancer Clinical Trials ◽  
First Line ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Factors Associated ◽  
Study Population ◽  
Few Data

6567 Background: Recruitment of patients in cancer clinical trials has been reported to be between 3%–5%. Very few data come from Canada. Methods: The objective was to measure the recruitment and its associated characteristics in hematology clinical trials for malignant diseases. This was a retrospective cohort study using charts review in a tertiary hematology centre in Québec City, Canada. Clinical trials opened between 2002 and 2008 were selected. For each protocol, main criteria were used to define the population under study (e.g., stage IV Hodgkin lymphomas first-line). If the patient filled the main criteria, all eligibility criteria (inclusion and exclusion criteria) of the protocol were assessed. Results: Among all charts reviewed, 697 patients were identified in 17 protocols. However, as a patient could be assessed for more than one protocol if applicable, this population reached 1,394 observations. The study population filling the main criteria of a protocol included 195 observations in 17 protocols (186 different patients). Only 9.7% (8.2–11.4) filled all the eligibility criteria and 3.3% (2.5–4.4) were recruited among all charts reviewed (1394 observations). However, theses rates reached 68.2 % (61.2–75.1) and 23.1 % (17.9–29.8), respectively, among patients meeting the main criteria of a protocol (195 observations). Recruitment in the population who filled all eligibility criteria (inclusion and exclusion criteria) was 33.8% (26.7–42.5). Patient's sex, age, comorbidities, doctor's sex, doctor's age and protocol characteristics were not associated with recruitment in the population filling the main criteria, but having a note in the chart about the protocol appears to be associated with higher recruitment (p < 0.0001). The most common reasons for not being recruited were as follow (could have more than one reason): 40.7% not fulfilling all eligibility criteria, 31.3% protocol not being proposed and 22.7% patients’ refusal. Patients reasons for refusals were (could have more than one reason): 50% unknown, 26.5% fear of side effects, 20.6% too many visits, 14.7 % already enough anxious about disease, other. Conclusions: The largest barriers about recruitment were protocol ineligibility and protocol not being proposed by the medical team. No significant financial relationships to disclose.

scholarly journals Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

2017 ◽  
Vol 35 (33) ◽  
pp. 3745-3752 ◽  
Author(s):  
Susan Jin ◽  
Richard Pazdur ◽  
Rajeshwari Sridhara
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
New Drug ◽  
Drug Clinical Trial ◽  
Oncology Clinical Trials ◽  
Eligibility Requirements

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

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.

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