An Important Gap in Informed Consent Documents for Oncology Clinical Trials

e17562 Background: Prediction of patient recruitment in OCT is one of the most important variables to guarantee timely closure of the trial. Earlier data analysis and conclusions define further research or discontinuation of the development of a given drug. Methods: Retrospective analysis of the recruitment and clinical records of all the patients of the COR that were contacted to participate in an OCT from 2006 to 2008 to identify the causes according to which patients did not participate. Results: Total of candidates 346, 175 women (50.6%). Average age 60 years (range 36 to 89). 42 patients (12%) rejected to participate in an OCT. 80 patients (23%) were screening failures (SF). 59 patients (17%) for not fulfilling an inclusion criteria (IC). Non appropriate stage or absence of measurable disease at screening (35%), abnormal labs (14%) and state of receptors or biomarkers (9%). Total of clinically unpredictable IC SF was 57.5%. 21 patients (6%) were SF due to an exclusion criteria (EC). Presence of distant metastases (12,5%), abnormal labs (2.5%) and abnormal EKG (2.5%). Total of clinically unpredictable EC SF was 19%. Conclusions: 35% of candidate patients did not participate. The most frequent cause was SF (23%). 76.5% of these SF were impossible to determine when informed consent was signed. 12% of patients rejected to participate for different reasons. Our results did not identify a predominant modifiable reason to improve recruitment. For future feasibility analyses our estimation of 35% dropout will be considered standard. [Table: see text] No significant financial relationships to disclose.

Download Full-text

1886P Quantifying quality of informed consent (IC) in patients enrolled in phase I (ph I) oncology clinical trials with a validated instrument (QuIC Parts A, B) in a large United Kingdom phase I trials unit

Annals of Oncology ◽

10.1016/j.annonc.2020.08.1533 ◽

2020 ◽

Vol 31 ◽

pp. S1072

Author(s):

A. Pal ◽

S. Stapleton ◽

J.E. Lai-Kwon ◽

N. Simoes ◽

A.R. Minchom ◽

...

Keyword(s):

Clinical Trials ◽

United Kingdom ◽

Informed Consent ◽

Phase I ◽

Phase I Trials ◽

Oncology Clinical Trials ◽

Validated Instrument

Download Full-text

The quality of informed consent forms for oncology clinical trials

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.6544 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 6544-6544

Author(s):

W. Y. Cheung ◽

G. R. Pond ◽

R. J. Heslegrave ◽

L. Potanina ◽

L. L. Siu

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Consent Forms ◽

Oncology Clinical Trials

Download Full-text

The Contents and Readability of Informed Consent Forms for Oncology Clinical Trials

American Journal of Clinical Oncology ◽

10.1097/coc.0b013e3181b20641 ◽

2010 ◽

Vol 33 (4) ◽

pp. 387-392 ◽

Cited By ~ 15

Author(s):

Winson Y. Cheung ◽

Gregory R. Pond ◽

Ronald J. Heslegrave ◽

Katherine Enright ◽

Larissa Potanina ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Consent Forms ◽

Oncology Clinical Trials

Download Full-text

Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult Oncology

Journal of Clinical Oncology ◽

10.1200/jco.2004.10.034 ◽

2004 ◽

Vol 22 (13) ◽

pp. 2708-2717 ◽

Cited By ~ 55

Author(s):

Christian M. Simon ◽

Laura A. Siminoff ◽

Eric D. Kodish ◽

Christopher Burant

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Randomized Clinical Trials ◽

Human Subjects ◽

Decision Makers ◽

Phase Iii ◽

Ethical Framework ◽

Clinical Cancer Research ◽

Oncology Research ◽

Oncology Clinical Trials

Purpose To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent. Patients and Methods A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using χ2 statistics and t tests. Results Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments. Conclusion Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

Download Full-text

Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.34_suppl.23 ◽

2012 ◽

Vol 30 (34_suppl) ◽

pp. 23-23

Author(s):

Andrew Schumacher ◽

Carolyn Bartley ◽

Anne Kaplan ◽

Benjamin Murphy ◽

Howard Safran ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Research Study ◽

Informed Consent Process ◽

Consent Process ◽

Research Participants ◽

Oncology Research ◽

Consent Document ◽

Oncology Clinical Trials ◽

Informed Consent Document

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.

Download Full-text