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Editor's Notes

• #3: In the next 30 seconds, someone will be admitted to hospital suffering from a serious adverse drug reaction - 6.5% of all patient admissions, over 1m admissions per year are serious ADRs, not including 400-500k within hospital ADEs.
• #4: It was a total shock to me to calculate that by the time we finish this talk, 2 people in the US will have had fatal drug reactions. 1 child will have had a life threatening drug reaction. Statistically, 1 of us in this room will end up in hospital from an adverse reaction this year.
• #5: If we want to understand any problem in America, we need to focus on who profits from that problem, not who suffers from the problem.
• #6: From 2003-2017, 0.3% of sales was spent on post market pharmacovigilance – for comparison purposes, less than the 0.5% share of popular vote Evan McMullin, the independent Mormon from Utah, won in the 2016 Presidential election.
• #7: Meanwhile total drug development costs are out of control. Estimates from Tufts show they have more than tripled in past 15 years.
• #8: We, as Drug Safety professionals are under ever increasing pressure to do more with less. Drug Safety is primarily viewed as a cost center.
• #9: Here is a top 3 pharma’s drug safety funnel. Where is the greatest cost and effort expended? It’s where the least attention is paid – distributing to sites. 900k potential AEs, 373k ARs, 100k SARs, 10k SUSARS, 1.2 M RA reports, 25m Safety Letters.
• #10: Call to Action 1 - review your safety distribution costs in your contracts. You will be stunned at the inconsistency. Sometimes costs are per site, sometimes per safety letter, sometimes flat fee. Across different trials on same compound the costs will be different even with same provider.
• #11: You may well uncover a cash cow in disguise. The largest cost I’ve seen on 1 trial for Safety Reporting is $7.8m for a 4 year trial. Clinical trials safety reporting costs are often hidden in other budget line items, so we don’t know what the real cost is.  
• #12: Call to Action 2 - Centralize safety reporting within your organization to eliminate over-spend. Safety Reporting is a compound level activity that belongs in drug safety not clinical operations because of cross reporting.
• #13: This is our current reality … Inside every single one of us, we have the most powerful device known to humankind  And that's an idea. 
• #14: Our idea was to build a universal safety transporter. Imagine saying “Computer, “beam” my safety information to the right person at the right time anywhere in the world. We were a couple of centuries early for star trek so we had to build the platform ourselves. It has taken us more than 7 years.
• #15: An idea is powerless if it is communicated and doesn’t resonate. 2 of the top 3 Sponsors, 1 of top 3 CROs, 1 of top 3 biotech and 2 of top 3 IRBs understood the economic, safety and compliance reasons to embrace the future and implement precision safety reporting – getting the right information to the right person at the right time anywhere in the world according to local laws. Our first task was to assemble all the different country legislation so we could build a rules-based artificial intelligence. It was a more painstaking journey than we envisaged.
• #16: Why is it that safety reporting seems to be more difficult every year, despite the advances and new technologies available? Clinical trials are complex Very large clinical trials are magnifying some of the underlying problems we face managing global and local teams and multiple partners
• #17: Lack of Global Harmonization is No 1 problem listed by pharma executives Regulations are unclear and rules vary from country to country. Marketing status, Expanded Access, Investigator-initiated trials all cause rules to vary No clear accountability for who is responsible for what
• #18: No standard process for sponsors to follow to distribute safety reports with the precision needed by our sites and ethics so they can focus on what they need to manage patient safety in the study Safety report distribution is managed by study teams resulting in many interpretations of what is needed No clear country rules. We have countries where Investigators require all SUSARs vs those that do not require any or country specific or protocol specific SUSARs
• #19: Fear of regulatory repercussions results in many companies sticking to the old Drug Safety mantra of “Send the same thing to everyone” even though legislation is constructed differently in different countries to spread burden between RAs, ECs, Sponsors and Investigators. Quality oversight to know the sites and ethics have gotten the right information is difficult. Many sponsors cannot trace the chain of custody of their unblinded information to ECs when inspected. Safety Reporting is often managed on a study by study basis resulting in over-distribution but clinical trials sites typically are participating in an average of 3 or more studies
• #20: 80% of sites get more than 20 SUSARs per month 20% have refused to process a SUSAR because it was an over-distribution e.g. A US IND Safety Report with non-sponsor causality or a SUSAR sent to an Australian investigator, who should receive line listings, not individual reports per country rules.
• #21: What did we build in order to overcome these challenges? A rules-based Artificial Intelligence that uses an evolving safety reference model of regulatory Intelligence from 125+ countries to power precision distribution to sites, EC and RAs in those countries. The AI considers causality, blinding and unblinding, RSI, cross reporting, country rules, local site and EC rules when making its distribution decisions. Inspection Readiness and traceability were at the core of the design – always distribute to local laws and alert those responsible in real time if there is a transmission failure and a risk of sites/ECs not getting timely information.
• #22: PI at Columbia University
• #23: Average reduction in Safety Reports = 5 2 hours per Safety Report Measured over 30k sites
• #24: Trained active users accessing system and receiving delivery.
• #25: Figures measured from over 2000 trials. 175k vs basic technology and 450k vs manual distribution.
• #26: By eliminating over-distribution of safety reports, you will transform your clinical operations, improve patient safety, reduce site burden, improve compliance, and save money.
• #27: Change is never painful, only resistance to change is painful. Join us in building the safety reporting reference model. May all your future safety reporting be accurate and precise.