What are In Silico Trials
We define In Silico Trials as the use of computer simulation to assess the safety and/or efficacy of new health care, whether medical devices, medicinal products, or others.
The use of computer simulations to support the medical decision has been addressed from a regulatory point of view since 2007 (Software as a Medical Device, SaMD), however, the use of computer simulation to test new healthcare products is relatively new, and beside a few guidelines, there is only one detailed resource for the validation of In Silico Trial medical device technologies: ASME V&V-40 standard.
The validation of In Silico Trials:
the ASME V&V-40 standard
While the V&V-40 is precious resource, it is of our opinion that there is the need for a broader document that summarises the good practices that are emerging in this very innovative field. Such document should play the same role that the Good Clinical Practice (GCP), the Good Laboratory Practice (GLP), or the Good Manufacturing Practice (GMP) play. Thus, by analogy, we named this document “Good Simulation Practice”.
GxP standards are developed by standardisation bodies, such as ICH or ISO. However, the field of In Silico Trials is not fully developed yet, and much of the technical expertise is concentrated by a relatively small group of experts, working in academia, industry, and in regulatory agencies. Thus, before a formal standardisation process is started, it might be useful to promote an open, public grass-root consensus process to collect and organise all the available knowledge on this topic.
The GSP Task Force
The Avicenna Alliance has created a GSP Task Force within its Policy Development Working Group. The Task Force is chaired by Luca Emili (In Silico Trials Technologies S.p.A.) and Marco Viceconti (University of Bologna), with the scope to drive this consensus process, develop this collection of draft and supporting documents, and then provide a sounding board to future standardisation efforts as part of a global GSP Initiative.
The GSP Initiative is a grass-root initiative, open to individuals and organisations.
Individual experts, regardless of their affiliation or geographic location, are welcome to join. All relevant expertise is welcome: patient representatives, technical experts, clinical experts, regulatory experts.
Organisations can participate by publicly endorsing the GSP Initiative and allowing their employees to actively contribute to the GSP activities.
In order to be as influential as possible, and also to ensure that all stakeholders contribute to the consensus process, we would like to extend the endorsement of the GSP Initiative from the two founding organisations, Avicenna Alliance and VPH Institute, to many others.
A first extension, currently being formalised, will see the close collaboration with the Medical Device Innovation Consortium (MDIC). Going forward, we need to work with a much wider range of organisations.
Ideally, we aim to engage with trade organisations (e.g., European Federation of Pharmaceutical Industries and Associations, Pharmaceutical Research and Manufacturers of America, MedTech Europe), national and federal regulatory agencies (e.g., FDA, EMA, AIFA, BfArM), patient organisations, and large payers / HTA Bodies (e.g., NICE, AQuAS).
Our goal will be to inform and communicate about this initiative, seek for advice, inputs, and comments, and eventually look for a large endorsement of such organizations.
We welcome the help of all participants to inform such organisations about the GSP initiative and introduce us to them.
#GoodSimulationPractice channel on the In Silico World CoP
On the online community of practice InSilicoWorld we have recently created a new public channel, called #GoodSimulationPractices, which will host all the discussions the consensus process requires. If you are already a member, join the channel here. If you are not a member yet, fill the form here.
Collection of relevant documental resources
One of the first accomplishments of the GSP Initiative is the collection of documental resources that could inform our consensus process. The list of collected resources with links to access them is available on the Good Simulation Practices page. We plan to continuously expand this list (all members of the GSP Initiative are invited to check and let us know if something is missing) and rationally organise the resources.
Publication of the list of Contexts of Use
One of the first outcomes of the GSP Initiative is an exhaustive list of how In Silico Trials can be used. The long list of what are called, in regulatory jargon, the Contexts of Use (CoU), will be packaged as a perspective paper, to be submitted for publication to an international peer-reviewed journal. If you contributed to the original list, and if you want, you can be a co-author of this paper. In that case, please contact Marco Viceconti
Resuming the consensus process
As soon as the #GoodSimulationPractice engages with enough members, we will resume the consensus process by promoting a collaborative writing of the first chapter, the introduction of the GSP draft document.