EHA at ICH meeting: Excessive bureaucracy harms patient safety and innovation
To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).
EHA was represented by Professors Martin Dreyling, Christian Gisselbrecht and Steven Le Gouill. The latter participated as a panelist in Session V: Data Sources. The meeting offered plenty of opportunities for (on-site) attendees to provide input. Following each panel, there was an opportunity for members of the audience to comment or ask questions, and attendees could also sign up to contribute open comments at the end of the meeting. The EHA delegation made excellent use of such opportunities and used every possible occasion to deliver EHA’s message.
Prof. Le Gouill’s presentation focused on how ICH overinterpretation perverts the initial aim of optimizing patient safety, as truly important signals are lost, diluted in an unmanageable number of trivial queries and unfiltered notifications of suspected unexpected serious adverse reactions. It is important to note, he pointed out, that overinterpretation not only has a major impact on patient safety but also on innovation. The consequent bureaucracy leads to an increase in the cost of clinical trials and thus the affordability and accessibility of new drugs, while constituting a death sentence for independent research. He concluded with a reminder that stakeholders (and referring in particular to clinicians and patients) should be involved in the whole drafting process instead of only being asked to review the near-final draft.
The points of overinterpretation, excessive safety reporting and early stakeholder involvement were brought up multiple times during the meeting. Prof. Louise Bowman (European Society of Cardiology/University of Oxford), Dr. John Buse (Division Chief and Director of the Diabetes Center, UNC), Dr. Rosa Giuliani (European Society for Medical Oncology), Dr. Janet Wittes (Statistics Collaborative Inc.) and Dr. PJ Devereaux (Director of the Division of Perioperative Care, McMaster University) were some of the aligned voices. To tackle these issues, ICH was requested, amongst other things, to: (1) eliminate those parts that may lead to overinterpretation and use a more forceful and concise language, avoiding vague or ambiguous terms; (2) include specific recommendations to sponsors, who are by nature risk-adverse and unlikely to change their processes and approaches without a firm direction to abandon their old habits; (3) further define the guidelines for the collection and use of electronic (including real-world) data; and (4) involve all stakeholders from the beginning and throughout the drafting process.
The comments collected during the meeting will be shared with the ICH E8 Expert Working Group representatives, many of whom were in attendance, and considered for the revision of E8, which is expected to be finished by June 2020.
For more information on the revision of the ICH Guidelines on Clinical Trials, click here.