AN OLDER ADULT PERSPECTIVE ON USING TABLET-BASED CONSENT FORMS FOR ENROLLMENT IN CLINICAL TRIALS

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

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4500 Providing a System for Practical Monitoring Training for Clinical Trials within Academic Institutions

Journal of Clinical and Translational Science ◽

10.1017/cts.2020.348 ◽

2020 ◽

Vol 4 (s1) ◽

pp. 114-115

Author(s):

Advaita Chandramohan ◽

Sukhmani Kaur ◽

Eunjoo Pacifici

Keyword(s):

Clinical Trials ◽

Academic Institutions ◽

Educational Module ◽

Consent Forms ◽

Study Protocols ◽

Clinical Research Coordinators ◽

Monitoring Visit ◽

Source Data Verification ◽

A Site ◽

Monitoring Report

OBJECTIVES/GOALS: The goal was to understand the effectiveness of a novel clinical trial educational module and a corresponding initiative designed and disseminated by the Southern California Clinical and Translational Science Institute (SC-CTSI) to increase the quality of clinical trials conducted in academia. METHODS/STUDY POPULATION: The CRCs (Clinical Research Coordinators) for the initiative are asked to complete the online training. Possible study protocols are picked to be monitored by the CRCs. The monitor is instructed to study the protocol extensively and prepare for their monitoring visit. The trained monitor from the initiative then reaches out to the CRC of the study that is to be monitored and carries out the monitoring visit. Afterwards, the monitor sends initiative personnel the monitoring report, which is evaluated to see if the monitor checked everything they should have during the visit. The PI of the study is contacted with highlights from the monitoring report and improvements that they can make. RESULTS/ANTICIPATED RESULTS: The first study monitored was a site of a large NIH-sponsored study where the consent forms were signed electronically. It was found that the monitor could not access the consent forms. Therefore, the monitor could not do source data verification. The PI of the study said that they would be raising this issue with the NIH. During the monitoring visit of the second study chosen for the initiative, patient binders were specifically examined for informed consent and source documentation completeness. The charts of patients were also reviewed. The only deviation found was a missing signature in the Investigator Site File. For the last two studies, data will be reported. DISCUSSION/SIGNIFICANCE OF IMPACT: Monitors were not only able to monitor efficiently, but also able to point out deficiencies in the monitoring practices of large studies. This model could be expanded to other academic institutions to establish quality management systems to ensure data integrity and subject protection.

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Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials

Journal of Cancer Education ◽

10.1007/s13187-020-01757-7 ◽

2020 ◽

Author(s):

Quyen Duong ◽

Sumithra J. Mandrekar ◽

Stacey J. Winham ◽

Kathryn Cook ◽

Aminah Jatoi ◽

...

Keyword(s):

Clinical Trials ◽

Funding Source ◽

Cancer Clinical Trials ◽

Consent Forms

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Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service

European Journal of Neurology ◽

10.1111/ene.14420 ◽

2020 ◽

Vol 27 (10) ◽

pp. 1825-1831

Author(s):

A. G. Jaramillo Vélez ◽

M. Aguas Compaired ◽

M. Granados Plaza ◽

E. L. Mariño ◽

P. Modamio

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Patient Information ◽

Consent Forms

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The adequacy of consent forms for informing patients entering oncological clinical trials

Annals of Oncology ◽

10.1093/oxfordjournals.annonc.a059352 ◽

1995 ◽

Vol 6 (9) ◽

pp. 867-870 ◽

Cited By ~ 38

Author(s):

I.N. Olver ◽

L. Buchanan ◽

C. Laidlaw ◽

G. Poulton

Keyword(s):

Clinical Trials ◽

Consent Forms

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Trends in the content and format of main and optional consent forms in oncology clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.15_suppl.e18177 ◽

2016 ◽

Vol 34 (15_suppl) ◽

pp. e18177-e18177

Author(s):

Sonja Rummell ◽

Leo Chen ◽

Winson Y. Cheung

Keyword(s):

Clinical Trials ◽

Consent Forms ◽

Oncology Clinical Trials

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Trends in the content and format of main and optional consent forms in oncology clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.153 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 153-153

Author(s):

Sonja Rummell ◽

Leo Chen ◽

Winson Y. Cheung

Keyword(s):

Clinical Trials ◽

Reading Level ◽

Phase Iii ◽

Cancer Center ◽

Consent Forms ◽

Flesch Reading Ease ◽

Gi Cancer ◽

Oncology Clinical Trials ◽

Cancer Studies ◽

Over Time

153 Background: Informed consent forms (ICFs) should provide prospective subjects with an opportunity to balance the risks and benefits of study participation. However, there are growing concerns about the quality of ICFs. Optional ICFs are also increasingly used as the number of companion studies and biomarker evaluations requiring additional tests become more frequent. We examined trends in the content and format of main and optional ICFs. Methods: ICFs from clinical trials at a tertiary cancer center in British Columbia from 2000 to 2015 were reviewed. We focused on breast or gastrointestinal (GI) cancer studies. Readability was evaluated with the Flesch Reading Ease Score (FRES) and Flesch Kincaid Grade Level (FKGL) where a higher FRES (maximum 100) and a lower FKGL (maximum 12) indicated easier readability. We applied t-tests and linear regressions to examine variations among clinical trials and changes over time. Results: We identified 133 main ICFs of which 70% had optional ICFs and where 57% and 43% were breast and GI cancer studies. Phase III trials (44%), industry funded investigations (70%), and studies involving palliative therapies (72%) were most common. Trials from recent years were more likely to have optional ICFs than those from earlier years (p < 0.001). The median length and median word count in main and optional ICFs were 16 and 6 pages and 6183 and 1862 words, respectively. These changed significantly over time whereby main ICFs increased approximately by 1 page and 364 words per year over the 15 year period (p < 0.001). Industry funded trials also had longer ICFs (p = 0.006). Study methods, risks, and confidentiality occupied 29%, 20%, and 11% of the content on ICFs, respectively. Sections pertaining to eligibility (p < 0.001) and screening procedures (p = 0.007) also increased with time, particularly for industry funded studies (p = 0.006). In terms of readability, optional ICFs were generally more difficult to read than main ICFs (FRES 48.3 vs 50.0, p = 0.024; FKGL 11.8 vs 11.1, p < 0.001), especially in recent years (p < 0.001). Conclusions: This is one of the first analyses to include optional ICFs. Length of ICFs is increasing and readability is discordant with the average reading level of potential trial participants.

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