The Call for Harmonization

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Wounds or HMP Global, their employees, and affiliates.

Dear Readers:

In the 1990s, representatives from the European Union, the United States, and Japan got together to develop the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In October 2015, this changed to the International Counsel for Harmonization. I think many of us in the research community are very familiar with this, as the offshoot of the work by this group led to what we consider good clinical practice. Quite frankly, these standardized guidelines for clinical research are really focused on investigational drugs. However, the number one goal of this standardization was more efficient use of resources as well as to improve the efficacy and reduce the need for redundant testing. It is interesting to note that the US Food and Drug Administration has not adopted the ICH standards and only uses them as guidelines. So much like the United States' stance on global warming, our regulatory bodies' stances are not truly harmonized with large portions of the rest of the world.

The mission of the ICH is "to achieve greater harmonization to ensure the safe, effective, and high quality medicines are developed and registered in the most resource efficient manner." It seems that we can do a better job of making sure that all our studies in wound medicine and wound surgery fit all these guidelines appropriately. In part, this would allow us to use studies that are conducted in the European Union and in other countries more efficiently for own processes here in the United States. The need to duplicate studies across the Atlantic and Pacific Ocean seems wasteful of human capital and limited resources.

For medical devices, we are directed to the International Organization for Standardization (ISO) clinical investigations on medical devices for human subjects – GCP 2011. This document is slightly different than the International Counsel on Harmonization, while it defines and provides good clinical practices for medical devices (not pharmaceuticals), its primary goal is again to minimize redundancy of studies, and more notably to provide guidelines around the rights of those participating in clinical research.

Publication requirements in Wounds have required notation in regard to IRB approval or exemption; the future requirements may include authors providing a copy of the IRB exemption letter for studies that are stated to be exempt. Comments in regards to the Declaration of Helsinki guidelines will be required. In the near future, comments in the Methods section of ICH or ISO guidelines as appropriate will also be requested. Ideally, when products are studied following the ISO guidelines, there will be better acceptance of the trial's outcome globally.

Most recently in the United States, the Wound Care Collaborative Community and the Wound Healing Society have worked on a set of guidelines for preclinical testing. The guidelines are designed to encompass both human and animal preclinical work. This comprehensive document will be known as the Wound Reporting of Animal and Human Preclinical Studies (WRAHPS). While this set of guidelines is in its infancy, it may also be a step in the right direction to develop a better understanding and more viable and efficient data production of wound-related basic science studies, while broadening the applicability of the data generated.

This researcher at times feels like there are too many regulations. However, efforts to make basic science more easily translational, while reducing the economic and human burden of clinical science, are efforts that I, for one, am strongly behind.

John C. Lantis II, MD, FACS
Editor-in-Chief, Wounds 
woundseditor@hmpglobal.com