Current expectations are that by 2030 the annual new cancer cases will reach 22.2 million people. There is an urgent need of new more efficient therapies to tackle raising cancer cases. Oncology clinical trials are part of the process to get new anti-cancer therapeutics on the market; however participation in clinical trials is low. According to the data for patients with colorectal, breast, lung and prostate cancer only 5% of the adults participate in clinical trials (less than 1 in 20 patients). While reasons for not willing to take part in research can vary data shows that up to 40% of the patients do not understand the inform consent information. [1]
Everyone involved in oncology clinical research is aware that inform consent could be a lengthy document with overwhelmingly many details, legal and regulatory language which is mandatory to be included, and extensive list of adverse events that put off patients.
International group of oncologists (Aide et Recherche en Cance´rologie Digestive (ARCAD)) has decided to tackle the issue by suggesting a new format for the inform consent form, which they consider will provide more clear information and expectations to patients.
What do they propose?
  • Separate inform consent into parts with leading part consistent of 1200-1800 words (3-5 pages), which includes: study title, reason for conducting research, brief description of the treatment and possible alternatives, frequency of the visits and examinations which are not standard of care, potential risks and benefits of the participation, clinically significant adverse reactions.
  • Supplementary part, which is 2000-3000 words (5-7 pages) that will include more details on adverse events, regulatory and legal requirements and other information.
  • Less information on risks – the authors suggest that as the treatment is new patients should be provided only with risks which are identified so far for the specific anti-cancer compound and avoid speculations.
  • Less adverse events – the authors explain that while there is no guidance regarding adverse events from FDA, EMA has recommendations and that only relevant adverse events and their frequency are included in the leading part. Additional adverse events could be listed in the supplementary part.
  • Life expectancy to be included – the authors believe, that although many oncologist may be reluctant to discuss life expectancy, that information needs to be included in the inform consent. They argue that this is important part that will help patients make the right decision. According to them some patients may decide against participating in a clinical trial if there is no relevant for them change in life expectancy.
Starting the discussion about the inform consent issues and providing recommendations is a major step in the right direction. The international medical and research community needs to adopt a new approach to empower patients to participate in clinical research. Although the consent form is just one part of a major challenge, it is an important part that needs to be addressed.
Source
  1. A step towards the harmonization of clinical trials inform consent forms
  2. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group
Published on 3 October 2017
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe
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