1369P - Not at all simple: The lay language summary of oncology clinical trials results. Challenges in implementing the new EU regulation (536/2014)

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Bioethics, Legal, and Economic Issues
Presenter Amanda Nottbohm
Citation Annals of Oncology (2016) 27 (6): 474-482. 10.1093/annonc/mdw387
Authors A. Nottbohm1, C. Weiss-Haljiti2, T.M. Schindler1
  • 1Medical Writing Europe, Boehringer Ingelheim Pharma GmbH&CoKG, 88397 - Biberach/DE
  • 2Medical Writing Europe, Boehringer-Ingelheim Pharma GmbH&CoKG, Biberach/DE

Abstract

Background

The new EU clinical trial regulation (536/2014) mandates that for every clinical study conducted in the EU, a summary of the results "that is understandable for laypersons" needs to be developed. At the time of abstract writing (May 2016), the regulatory guidance for the content of these lay summaries is limited to a 10 bullet point list in Annex V of the EU-regulation. Therefore sponsors of clinical studies need to develop their own approach to the writing of these documents.

Methods

The objective was to develop a template for lay summaries for oncology clinical trials. We decided that the content of the lay summary should not exceed the data provided in the synopsis of the clinical study report. In a small team of professional medical writers (n = 5) different versions of lay summaries were written and each version was reviewed and critiqued. After revision each version was tested for readability using health literacy principles and the Flesh Reading Ease score. The presentation of the information followed the “inverse pyramid principle” that provides overview information first and then the details. For the development of the template we also used guidance documents from MRCT, HRA, EFPIA and TransCelerate. Accordingly, lay summary should be written for a reading level of 11 to 12 years of age. We hypothesized that lay summaries should short to facilitate comprehension and reduce reading load.

Results

The main issues for the development of a lay summaries were: the need for a lay title, the description of the study design (using graphics), choice of the most important in- and exclusion criteria, presentation of primary efficacy endpoint along with statistical measures, the description of safety data (lay term and CTCAE term), and the overall conclusion on the study. The final template arranged the information in 10 paragraphs with each one being introduced by a question. The amount of white space and the use of graphics and tables was optimised for lay readers.

Conclusions

The final template allowed the presentation of oncology clinical study results for laypersons. However, the intended target reading level (11- 12 years of age) could not be achieved.

Clinical trial identification

Legal entity responsible for the study

Boehringer Ingelheim Pharma GmbH&CoKG

Funding

Boehringer Ingelheim Pharma GmbH&CoKG

Disclosure

All authors have declared no conflicts of interest.