Recommendations for Enhancing Clinical Trials Education: a Review of the Literature

Abstract

This study aims to apply the evidence-based practice (EBP) process to determine the factors that influence patients' understanding of, participation in, and satisfaction with clinical trials, the informed consent process, and treatment decisions and to make recommendations for improving clinical trials education. Beginning with evidence retrieval, the authors identified key search terms and searched MEDLINE--Ovid, MEDLINE--PubMed, and the Cumulative Index to Nursing and Allied Health Literature to identify articles published between July 2001 and July 2006 that highlighted clinical trials education. The articles were reviewed for clinical trials patient education information, clinician methods of communicating clinical trial information to patients, and patient satisfaction with the clinical trials process, including the informed consent process. As a result, practice changes were recommended for the patient/family, staff/community, and institution. From the literature review, 81 articles were identified. Recurring themes included decision-making, patient education, staff education, and pediatrics. Most articles focused on methods and strategies aimed at improving education at the patient/family, staff/community, and institutional levels. The issues surrounding clinical trial education are complex due to multiple variables interfering with poor patient understanding of, participation in, and satisfaction with clinical trial treatment decisions. On the basis of our findings, we recommend that clinicians involved in educating patients, families, staff, and communities about clinical trials have an awareness of and understanding for very complex issues.

A Comparison of Patient Knowledge of Clinical Trials and Trialist Priorities

“…There are many obstacles to recruitment. They can include the availability of an appropriate trial, physician comfort in recruiting patients, eligibility restrictions of the research protocol 4 , patient comorbidity, and practical considerations such as time commitment and transportation 5 . Fundamental to patient recruitment and valid consent to a clinical trial is that patients understand and accept the principles that directly affect their care 6 .…”

Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial

“…A meta-analysis of cancer-specific screening and treatment contexts demonstrated improved knowledge and reduced decisional conflict among patients receiving DAs vs controls (O'Brien et al , 2009). Although there has been interest in using DAs to support decision making about clinical trial participation (Brehaut et al , 2009, 2010; Stepan et al , 2011), their efficacy has not been systematically evaluated in this context, and their influence on participant dropout is unknown. To our knowledge, this study is the first RCT of a DA specifically developed for a clinical trial.…”

Parental perceptions of the informed consent process in pediatric oncology clinical trials

“…Information documents and written resources strengthened the verbal presentation by staff, but were not considered more important in achieving clarity of information. In the developed world, the majority of children with a pediatric oncology condition will enroll on a clinical trial [8,17,24,[34][35][36] . Parents play a critical part in ensuring this treatment will be in the child's best interest [12,37] , but whether they possess a comprehensive understanding of the process involved is questionable.…”

“…Despite the recognition of the importance of adhering to the principles of informed consent, and the need to respect the rights and autonomy of individuals regardless of age, there is a paucity of evidence informing best practice for this process. There is a need to understand how the informed consent and assent process in the pediatric oncology setting is understood by parents of children receiving treatment as part of a research clinical trial protocol [9,24] .…”