The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been developing a new protocol template and accompanying guideline, ICH M11. This template is designed to be used globally for all categories of interventional clinical trials, and all phases of research. Representing the early phase investigative community, Richmond Pharmacology contributed to the public consultation of this initiative.  Our comments and proposals were submitted independently and via the European CRO Federation (EUCROF) as summarised below.

Richmond Pharmacology is owned and managed by very experienced and distinguished Principal Investigators and Co-investigators, we are experts in early phase clinical research. Our comments and proposals stem from three decades of continuous practical experience as early phase investigators. 

We are also training a new generation of early phase investigators who will see many advances in clinical research. We wish to train and guide this next generation of investigators to safely respond to such advancements with flexibility and ingenuity. As such, we have outlined how the proposed ICH M11 template is unsuitable for early phase and exploratory research.

To enable us to continue designing and performing safe and innovative early phase trials that provide fast patient access to new and advanced therapies, we have requested that the Expert Working Group considers the following three potential solutions:

  1. Exemption:  Should ICH wish to continue developing the template in its current format and content, we would request a clear statement in the ICH M11 guideline that exploratory early phase clinical trials are explicitly exempted from the use of the proposed protocol template.
  2. Creation of a platform using conditional formatting and input to distinguish between exploratory and confirmatory trials: Rather than developing a one-size-fits-all template, ICH could, in collaboration with subject matter experts, develop an electronic platform that allows conditional input of protocol sections required for the two main categories of trials.  Using appropriate filters, the platform would ensure that only those sections are presented that collect and collate data appropriate for the category of trial.  There could be mandatory sections that are presented for all trials once the relevant category has been selected, and optional modules that can be opened and completed as needed.
  3. Creation of a publicly accessible library of best-practice modular protocol sections, from which stakeholders can choose those that are relevant for a clinical trial, and which are kept up to date by all relevant subject matter experts. This would be the most adaptable, collaborative, up to date, and least prescriptive approach. It could be compared to the very helpful initiatives and guidelines provided by the Heads of Medicines Agencies’ Clinical Trials Coordination Group (CTCG), e.g., on contraception and complex clinical trials.

In our response to ICH M11 public consultation we provide the rationale for these proposals in the following sections, focusing on key themes presented by the ICH Expert Working Group in the draft ICH M11 guideline, and during the presentations given at a public webinar on 26 January 2023:

  1. Electronic transferability of modular protocol sections
  2. Time and cost savings during drug development to improve patient access
  3. Practical use of an “off-the-shelf” protocol to investigators
  4. Compliance of protocol design with the “quality by design” principle 

To view our full comments, rationale and proposal to the ICH M11 public consultation please see the attached

It was essential that Early Phase Investigators are appropriately represented in this significant area of discussion.  We wish to continue to work towards the best possible future for early phase research. 

To find out more about this process, please email

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