When I established the ASA Biopharm Safety Monitoring Working group in 2015 (with Bill Wang), one of the first things that we did (with Susan Duke and Mac Gordon) was to interview key opinion leaders for their views on the current state of drug safety quantification in our industry and where they envisioned it would be in 5 years (see KOL list below).
They identified 4 pillars of Safety Statistics for the near future:
1. Cross-disciplinary Scientific Engagement
- Clinical judgment is critical; however, quantitative thinking improves the quality of the discussion and decision-making
- Most believed that a dedicated safety statistics group would be the best way to support clinical safety; others favored a small consulting group
2. Operational Process
- Ongoing program-level safety assessments must be embedded into the process of how sponsors learn and communicate about safety
3. Visual & Analytic Methods
- Clinical judgment for decision-making requires aggregate but not purely quantitative analyses to establish causality and identify high-risk subgroups
- Graphics are a way to point people in the right direction, but they need an engine to look more deeply into things
4. Data Infrastructure
- A proactive safety strategy requires connectivity between pre- and post-marketing processes among drug safety, epidemiology, and safety statistics (and other experts)
Safety evaluation during clinical development requires a partnership between clinical safety professionals and safety data scientists: 1) a thorough understanding of the existing safety data, target population and relevant subgroups, and risk factors for particular AEs and 2) a cumulative meta-analytic review as a routine part of the safety monitoring process so that increases in AE rates can be detected and characterized as readily as possible. And this is why the ASA Biopharm Safety Monitoring working group (and members at companies like AbbVie and Merck) pioneered the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group (co-leads: Greg Ball, Jim Buchanan, Susan Duke, and Mengchun Li) to develop the Aggregate Safety Assessment Planning (ASAP) process (ASAP Process working group co-leads: Barbara Hendrickson and Lothar Tremmel). More about this in a couple blog posts from now…
Key Opinion Leaders (name and affiliation in 2016):
- Conny Berlin (Novartis)
- Mondira Bhattacharya (AbbVie)
- Aloka Chakravarty (FDA)
- Christy Chuang-Stein (Pfizer)
- Brenda Crowe (Lilly)
- Dave DeMets (UW)
- Lily Krasulja (Janssen)
- Juergen Kuebler (CSL Behring)
- Mark Levenson (FDA)
- Olga Marchenko (Quintiles)
- Walter Offen (Abbvie)
- Frank Rockhold (Duke)
- Frank Shen (Abbvie)
- Valerie Simmons (Eli Lilly)
- Steve Snapinn (Amgen)
- Bob Temple (FDA)
- Jose Vega (Merck)
- Janet Wittes (Statistics Collaborative)