Improving attribution of adverse events in oncology clinical trials

2019 ◽  
Vol 76 ◽  
pp. 33-40 ◽  
Author(s):  
Goldy C. George ◽  
Pedro C. Barata ◽  
Alicyn Campbell ◽  
Alice Chen ◽  
Jorge E. Cortes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Oncology Clinical Trials

Diarrhea in Placebo Arms of Cancer Studies

2021 ◽  
Vol 1 (5) ◽  
pp. 379-385
Author(s):  
BIRTE J. WOLFF ◽  
JOHANNES E. WOLFF
Keyword(s):  
Clinical Trials ◽  
Literature Review ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
Cancer Prevention ◽  
Cancer Patients ◽  
Systematic Literature Review ◽  
Oncology Clinical Trials ◽  
Prevention Studies ◽  
Cancer Studies

Background/Aim: Diarrhea is among the most common adverse events in early oncology clinical trials, and drug causality may be difficult to determine. Materials and Methods: This is a systematic literature review of placebo arms of randomized cancer trials. Results: Anemia was reported in 95 of 127 placebo monotherapy cohorts. Publications involving healthy volunteers and cancer prevention studies reported lower frequencies than those with cancer patients. The average reported frequency of diarrhea grade 1 or higher among studies in cancer patients was 15%. The maximal reported frequencies for grades 1, 2, 3, 4, 5 were 56, 24, 6, 2, and 0%, respectively. Conclusion: When higher diarrhea frequencies than those are observed in treatment arms of clinical trials, then drug causality is likely.

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

2018 ◽  
Vol 15 (6) ◽  
pp. 616-623 ◽  
Author(s):  
Peter C Trask ◽  
Amylou C Dueck ◽  
Elisabeth Piault ◽  
Alicyn Campbell
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Selection Process ◽  
Late Phase ◽  
Relevant Information ◽  
Specific Patient ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial

2020 ◽  
Vol 38 (6) ◽  
pp. 1879-1887
Author(s):  
Bastien Cabarrou ◽  
Carlos Gomez-Roca ◽  
Marie Viala ◽  
Audrey Rabeau ◽  
Rodolphe Paulon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Oncology Clinical Trials ◽  
Alternative Approaches

scholarly journals Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e047294
Author(s):  
P Schöffski
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Stopping Rules ◽  
Data Monitoring ◽  
Independent Data ◽  
Oncology Clinical Trials ◽  
Life Threatening ◽  
Study Participants

The role and use of independent data monitoring committees (IDMCs) has evolved over the past decades. The Food and Drug Administration and European Medicines Agency have issued guidelines on the role and functioning of such committees. In general, data monitoring committees are recommended for large, often randomised clinical trials involving life-threatening diseases, studies performed in vulnerable populations or where the experimental intervention can potentially harm the trial participant. Such committees play an important role in trials evaluating treatments with the potential to prolong life or reduce the risk of major adverse health outcomes.Typically, oncology clinical trials fall within these recommendations, as they are often large, randomised, multicentric protocols aiming at improving survival outcomes by exploring the use of study treatments that may be associated with a significant risk of serious, even life-threatening adverse events. IDMCs are required for National Cancer Institute phase III randomised trials, European Organisation for Research and Treatment of Cancer phase II/III trials with formal interim analyses, early-stopping rules or adaptive studies. The primary role of an IDMC of ensuring the safety of study participants and maintaining clinical trial integrity is particularly important in oncology trials, due to the nature of the disease, the potential for treatment toxicity and for instilling confidence that the clinical trial data are reliable. A clear understanding by IDMC members of the natural course of the disease, treatment landscape, importance and relevance of certain adverse events in trial participants, clinical trial methodology in general and stopping rules for oncology trials in particular, is crucial for the functioning of an IDMC.It is recommended that IDMC members should be experienced trialists, have a track record of strong clinical, statistical and/or methodological expertise and the required level of independence, as they play a highly important role in the protection of study participants, and in commercially and strategically important go/no decisions. Ideally, IDMC members should have relevant experience or have some training, mentorship or guidelines.

A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials

2010 ◽  
Vol 29 (5) ◽  
pp. 1013-1020 ◽  
Author(s):  
Som D. Mukherjee ◽  
Megan E. Coombes ◽  
Mitch Levine ◽  
Jarold Cosby ◽  
Brenda Kowaleski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Adverse Events ◽  
Early Phase ◽  
Serious Adverse Events ◽  
Oncology Clinical Trials
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