IDMP, moving towards 'A single and shared source of truth for Product and Substance information'
paul houston
Chief Clinical Researcher @ TrialsofLife | Health Interventions, Community Engagement
If at the core of all the pharmaceutical and healthcare systems there was one dictionary of well structured terms the exponential advancements in public health and drug development would be immeasurable. This great article highlights a few of the advantages the implementation of IDMP will bring:
ISO article: 'Curbing death and injury with safer medication' https://www.iso.org/iso/news.htm?refid=Ref2056
Beyond that the clinical trial registries of the world will be able to eventually populate their essential information repositories using the CDISC CTR2 https://www.cdisc.org/ctr-xml standard that will deliver rich, structured and IDMP compliant information.
With the advent of many clinical trial data sharing initiatives on the horizon https://opentrials.net/ and already in existence , see https://www.projectdatasphere.org/ or https://clinicalstudydatarequest.com/ it is foreseeable that the wasteful and repetitious drug development mistakes and cul-de-sacs will diminish and the worlds drug development resources can be more collaborative and progressive.
Data standards are the vehicle to get us there but they have to be adhered to and implemented broadly and the sharing and registration of accurate and invaluable life saving information on products and substances has to be absolute. The GINAS https://tripod.nih.gov/ginas/app project has been a passion project partly funded by governments but largely created, during free time, by dedicated individuals involved in the IDMP project so that controlled vocabularies exist to ensure IDMP is implementable.
All of the pieces are now coming together finally after a journey that started in ICH https://www.ich.org/home.html more than 12 years ago. I've seen so many people put in tremendous hours to improve the world of healthcare and medicine for all and it is an exciting time as this information age finally delivers real progression.
Transforming Regulatory Operations
8 年Good work Paul.
Clinical Standards Consultant at Joyce Hernandez Consulting, LLC
8 年In this document the FDA talks about an ongoing to create an IDMP compliant Product Dictionary as part of the CDER Master Data Management project.https://www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm455270.pdf
Clinical Standards Consultant at Joyce Hernandez Consulting, LLC
8 年Personalized medicine will help to ensure the right medication is prescribed. Here is a nice presentation on the IDMP project. HL7 in conjunction with ISO balloted a Common Product Model which documents the schema and vocabulary domains. https://www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm489459.pdf
Strategic Development & Transformation
8 年Nicely written, Paul! I will exactly be sharing some of these perspectives at my presentation at CDISC Interchange in Vienna next week. Hope to see you there...
Global Principal Pharmaceutical R&D/IT Data Consultant-OUTSIDE IR35 ONLY
8 年Excellent article Paul. Many thanks for sharing. Specifically the links were particularly useful.