Chair: Dennis Raisch PhD, RPh, Professor, University of New Mexico

Goal:
Identify and describe the links between RBM and health outcomes research in public policy and health care decision-making to assure the safe and effective use of pharmaceutical products and devices.

Links to Risk Management Policy Information & Drug Safety Alerts and Withdrawals

Risk Benefit Management News Updates
Informational web linkages that impact our field and may ultimately impact ISPOR.

The FDA recently created Risk Communication Advisory Committee.  For more information, http://www.fda.gov/oc/vonEschenbach/andys_take/default.html

Below is the link to the bill that reauthorized and expanded the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA).  As a result of this bill, the requirements for conduct of post marketing surveillance have been extended to more products and devices.  
http://www.fda.gov/oc/initiatives/advance/fdaaa.html

Risk Benefit Management WG Activities and Accomplishments 2002 - 2007

Current Projects:

Manuscripts

1. Risk Benefit Monitoring Worldwide
   Chair: Jayashri Sankaranarayanan PhD
   Team members: Arthi.B.Chandran MPH, BA;  Jeff J. Guo BPharm, PhD; Roland Marcus BS;
   Ashish Parekh BS, MS; Alfred Sackeyfio RPh, BSc
   
   
• Summary: An overview of current websites of regulatory agencies worldwide that give guidelines and policies for RBM monitoring.
• Expected final product: Publication in a peer-reviewed journal or ISPOR CONNECTIONS and the ISPOR website.
• Current status: Jayashiri has developed a table template for 98 countries worldwide.  Websites often available in only foreign languages or has different focus reflecting different regulations.
• Action: End of August timeline for member updates and October 2008 for first draft review.
  
  
2. Metrics & Methodologies to Quantify Risks & Benefits
   Co-Chairs: Jeff J. Guo BPharm, PhD & Kara Suter MS
   Team members: John Doyle DrPH; Brett Hauber PhD; Shital Kamble MS, MMS, PhD(c); Yvonne Lis PhD;
   Wendy Toler PharmD, PhD(c)
   
   
• Summary: There is a lack of standardized metrics/methodologies to quantify risks & benefits.  Paper will discuss the quantitative methods, their limitations, address problems, such as feasibility given the limitations and new developments toward a standard metric.
  Outline
• Expected final product: Short article for ISPOR CONNECTIONS in late 2008, with a possible follow-up manuscript for a peer-reviewed journal.
• Current status: Jeff has had a graduate student assist with this work. In process of literature review of different methodologies and performing qualitative analysis of different methods.  More than 10 manuscripts identified, comparisons are being tabulated
• Action: Jeff will review the work and potential draft by the end of August. Committee agreed to include student as co-author.  First draft for review by group October 2008.
  
  
3. A Comparison Across Industries of Risk Benefit Management Practices
   Chair: Tony Lockett MD, PhD, MBA
   
   
   • Expected final product: publication in ISPOR CONNECTIONS
   • Current Status: Literature review completed.  Updating a previous draft.
   • Action: Tony will review by end of August and send out for team review and comments by October 1.
     
     
4. Head to Head comparison of EMEA to US RBM Guidelines
   Co-Chairs: Jeff J. Guo, BPharm, PhD and Tony Lockett MD, PhD, MBA
   Team Members: Yvonne Lis PhD
• Expected final product: publication in peer-reviewed journal or ISPOR CONNECTIONS.
• Current status:  Revising /updating the previous draft.
• Action: Jeff will send revision to Tony soon.
  
  
5. Direct to Consumer Advertising and its Relationship to Risk Benefit Management 
   Chair:  Ashish Parekh BS, MS
   Team members: Joyce Addo-Atuah PhD; Ibrahim Al-Abbadi PhD, MBA, Bpharm; Rodrigo Deantonio MD, MSc;
   Roland Marcus BS; Alfred Sackeyfio RPh, BSc
   
   
• Summary: Opinion review on how RBM is incorporated into DTC.  The paper will discuss direct to consumer advertising in light of the recent FDA guidelines and clarify the effect DTCA has on communicating risks and benefits to patients and how this would impact the patient-provider interaction.
• Expected Final Product: publication in ISPOR CONNECTIONS.  It was suggested that a podium presentation rather than a workshop may have greater chance for acceptance at the next ISPOR meeting.  Ashish will consider this option.
• Current Status: Ashish needs another active member on the team.  The literature review is ongoing and a comprehensive outline for the paper is being developed.
  


6. Risks and Benefits of Health Care Treatments and Policies:  Appraisals by Experts in Health Outcomes Research
   Chair: Dennis Raisch PhD, RPh
   
   
   
• Expected final product: publication in peer-reviewed journal
• Current status:
  Response from Clinical Therapeutics
• Lack of IRB approval – could ask for post-study IRB approval or justify by time of conduct of survey (prior to IRB requirement), informed consent implied by agreement to respond (no pressure)
• Survey response rate is low (12%) - this is not usual from internet surveys.  Could do a early/late responders analysis
• Do not know these are experts, could be new graduate members – rephrase as members, not necessarily experts.  Also, degrees indicate represent of ISPOR/level of expertise.
• Options
• Split into two papers (1) Public policy/sources of info (2) Risk/benefit assessment of Pharmaceuticals
• Resend as is to Risk Analysis or Drug Information Journal
• Recommendations: A good paper, don’t give up, revise and resubmit without splitting
• Action: Dennis will resubmit by end of Sept. 2008