Poster Presentation Clinical Oncology Society of Australia 2014 Annual Scientific Meeting

Compliance with international guidelines and readability of informed consent forms for cancer clinical trials (#383)

James C Kuo 1 , Laeeq Malik 2 , Alex Mejia 2 , Desmond Yip 1 3
  1. Department of Medical Oncology, The Canberra Hospital, Garran, ACT 2605, Australia
  2. Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, Texas, USA
  3. ANU Medical School, Australian National University, Canberra, ACT 0200, Australia

Background: Informed consent forms (ICFs) provide information about clinical trials and assist patients in making an informed decision regarding their participation. The International Conference on Harmonization guidelines for Good Clinical Practice (ICH-GCP) recommended addressing 20 aspects of the consent process in ICFs, and using layman’s language in a document less than 15 pages to improve readability. We analysed the content of ICFs for cancer clinical trials to determine their compliance with ICH-GCP guidelines and readability.

Methods: ICFs for trials for metastatic cancer conducted at two institutions between 2011 and 2013 were reviewed. Non-therapeutic, observational, adjuvant and neoadjuvant trials were excluded. Contents were reviewed for inclusion of elements recommended by ICH-GCP. Page count and Flesch-Kincaid Reading Ease (FRE) score were used to assess readability.

Results: Of 154 ICFs screened, 112 ICFs met the eligibility criteria for inclusion. The majority were Phase I trials (n=57, 51.8%) and pharmaceutical industry sponsored (n=92, 82.1%). All ICFs stated the voluntary nature of participation, explained the purpose and the experimental aspect of the trial, discussed confidentiality aspects and provided an estimate of the potential risk and benefit. Fourteen of the 20 recommended elements were addressed by all ICFs. Areas of deficiency were statement about provision of up-to-date trial information after enrolment, the study schema, dose escalation, possibility of serious harm or death, and risks to pregnant/lactating women. The median length of ICFs was 20 pages and the median FRE score was 55.5, equivalent to a 10th grade reading level. Less than 15% of ICFs were written at the 8th grade reading level.

Conclusion: ICFs for cancer clinical trials were mostly compliant with ICH-GCP guidelines. However, these ICFs were lengthy and as suggested by the FRE score, fairly difficult to comprehend. Improvement in readability could be made by simplifying the language used and reducing the page count.