Abstract
BackgroundPatient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives’ views and perceptions on the written trial information used in clinical cancer trials.MethodsWritten patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis.ResultsTwo major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms.ConclusionsThe emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.
Highlights
Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate
The patient thereafter receives an informed consent form, which consists of two parts, i.e. an information sheet and a consent certificate
We explored patient representatives’ views and perceptions of written information used in clinical cancer trials through focus groups
Summary
Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. To guarantee autonomy and protect patients from harm, oral and written clinical trial information is provided; thereafter the patient gives an informed consent to participate [1]. Oral information about study concept, aims, randomization, risks and benefits and practical implications is provided by physicians and research nurses. The written information is typically extensive and should cover e.g. the purpose of the research, the type of intervention, participant selection, voluntary participation, information on trial drug/placebo, procedures and protocol, treatment alternatives, randomization, additional tests/investigations, duration, standards and guidelines, side effects, potential risks and benefits, reimbursements, confidentiality, sharing of results, contact information, and the right to refuse or withdraw from the study at any time without explanation and without compromised
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