oct 2016 kja slides _final

Case study: Risk and contingency management in clinical trials

Kevin J. Anderson, MBA

Associate Director, Clinical Operations

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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.

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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

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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

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Systematic Process Examination

• Could Not Change

• Could Change

• Not Working

• Working

Site Selection

Site start Up

Site & Patient

Centricity

Patient Recruit.

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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)

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Site Start Up– Regulatory & ECs

Tier Sites

Reg. Kick Off

Daily Calls Joint

Folders

You’re Off! Early

“Go”

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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

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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

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Site centricity

• Monthly PI calls

• Monthly SC calls

• Add staff

• Approve budget increases

• Apps and/or web portals

• Pay for pre-screening

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Patient Centricity

Patient centric organizations

Telemedicine

Social Media

Sharing data with patients

Home

Infusions

Wearable devices

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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

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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