OCT 2016 KJA Slides _FINAL
-
Upload
kevin-j-anderson -
Category
Documents
-
view
32 -
download
0
Transcript of OCT 2016 KJA Slides _FINAL
Case study: Risk and contingency management in clinical trials
Kevin J. Anderson, MBA
Associate Director, Clinical Operations
2
Disclaimer
The views and opinions expressed in the following
PowerPoint slides are those of the individual presenter and
should not be attributed to Alexion Pharmaceuticals, Inc.
(“Alexion”) or Quintiles Transnational, Inc. (“Quintiles”) or
their directors, officers, employees, volunteers, members,
chapters, councils, communities or affiliates, or any
organization with which the presenter is employed or
affiliated.
3
Agenda
Risk and contingency management on one program within
the Alexion-Quintiles partnership, including short term
mitigation and long term contingency planning for:
Slow site selection
Slow start up execution
Slow patient enrollment
Lack of site and patient centricity in study execution
4
Background
• 2 POC studies in the rare and ultra rare disease space
• Team had small budget, few sites
• Everything was far behind original projections
• Needed to mitigate current issues and map out a risk
management plan for future studies
• Team did and results were significant
• The lessons we learned can be applied broadly
5
Systematic Process Examination
• Could Not Change
• Could Change
• Not Working
• Working
Site Selection
Site start Up
Site & Patient
Centricity
Patient Recruit.
6
Site Selection
• Challenge our site numbers
• Reach out internally across therapeutic areas
• Global feasibility
• Search Engine Optimization (SEO) and social media
• Patient Advocacy groups
• Medical Informatics
• Clinical Trial Educator (CTE)
7
Site Start Up– Regulatory & ECs
Tier Sites
Reg. Kick Off
Daily Calls Joint
Folders
You’re Off! Early
“Go”
8
Site Start Up-Contracts
Start with medium budget
Country list to Legal/Contracts early
At country “go” both groups start on contracts
Weekly Prioritization Calls
9
Patient recruitment
F2F visits
Social Media Plan
Mobile DLs
Study Apps
SEO Plan
CTE
• Educate staff on recruitment techniques
• Network wit HCPs
• Offer creative solutions
10
Site centricity
• Monthly PI calls
• Monthly SC calls
• Add staff
• Approve budget increases
• Apps and/or web portals
• Pay for pre-screening
11
Patient Centricity
Patient centric organizations
Telemedicine
Social Media
Sharing data with patients
Home
Infusions
Wearable devices
12
Results
From .36 patients per month
To 2.5 patients per month
Chronic Study
From 1.25 pts/mo.
To 2.0 pts/mo.
Acute Study
From bottom 25%
To top 5%
SSV to SIV
13
Conclusions
• Risk & Contingency Management plans are critical
• Should have in place before studies start
• Perform ongoing reviews-should be living documents
• Quarterly F2F meetings with CRO are recommended
• If these occur, positive improvements on current and
future studies are highly likely