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Challenges of Phase I Units in Today’s
Changing EnvironmentDonna W. Dorozinsky, RN, MSN, CCRC
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Understand that we are not alone in the challenges that we face in Phase I
Identify some possible solutions to some of the most challenging issues
Objectives
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Pharma sponsored sites Hospital based Healthy male volunteers People writing the studies were part of the Unit’s operation
90 Day FTIM
Where Have We Been?
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Budget – What budget? Monitor my study? Are you kidding? Right of first refusal Studies on the shelf Simple molecules
Where Have We Been?
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Majority of Phase I studies are independent of Pharma
Cost competitive environment Complex studies Patient studies Professional volunteers Biologics
Where are we today?
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Non-scientific anonymous survey Sent to 40 individuals selected through ACPU membership, networks, meeting attendees
16 respondents – Thank You! 21 Operational Challenges 15 Clinical Challenges Some as expected Some Surprises
Identifying the Chanllenges
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Demographics of Respondents
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Sponsorship
6%
38%
31%
6%
19%
CPU OwnershipInvestigator owned Part of a large CRO Part of a small CROPharma sponsored Academic afiliation
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Bed Capacity
1-10 11-20 21-40 41-75 76-100 101-150 151+0
0.5
1
1.5
2
2.5
3
3.5
4
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Studies in Last 12 Months
1-5 6-10 11-15 16-20 21-25 26-30 31+0
0.5
1
1.5
2
2.5
3
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Last minute cancellation of studies by the sponsor◦8 respondents identified in the top 3
Adequate sponsorship funding◦6 respondents identified in top 5
Obtaining studies◦7 respondents identified in top 5◦4 respondents identified as #1 challenge
Greatest Operational Challenges
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Recruitment of patient population◦8 respondents identified in top 7
Adequate resources for employee development◦5 sites identified in top 5
Greatest Operational Challenges
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Healthy subject recruitment Planning bed occupancy Funding staff training
Equal Distribution Operational Challenges
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Complex study designs Ability to function independently of your sponsoring organization
Site security Access to emergency care Storage space
Not Considered to be an Operational Challenge
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Cash payment milestones PI recruitment Finding capable monitors knowledgeable in GCPs
Low employee morale Lack of leadership
Additional Operational Challenges
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Several clinics phase I-IV have opened in the proximities of the site
Sponsor canceling and postponing the projects.
Staff retention The time to effectively train PRN, agency and night staff on all protocols.
Additional Operational Challenges
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Security issues with subjects◦6 respondents identified in the top 5
Contraband◦6 respondents identified in the top 5
Excessive Data Queries◦6 respondents identified in the top 5
Greatest Clinical Challenges
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Concern that subjects are participating in multiple studies◦7 respondents identified in the top 5
Abnormal laboratory values◦8 respondents identified in the top 5
Greatest Clinical Challenges
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Incomplete delegation logs Missed procedures because of staff shortage
Clinical equipment old or in disrepair
Equal Distribution Clinical Challenges
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Emergency response capabilities Illiterate research subjects
Not of Clinical Concern
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Ensuring that staff address data issues (corrections)immediately after they are identified
Finding new staff to hire with Phase 1 Clinical Research Experience or even late phase experience that can be trained for Phase 1 staffing
Additional Clinical Concerns
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Sponsors don’t understand the challenges of executing these complicated protocols
25.00%
43.75%
18.75%
12.50%
Strongly agreeAgreeNot sureDisagreeStrongly disagree
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Monitors are inexperienced in monitoring these complex studies
12.50%
37.50%37.50%
12.50%
Strongly agreeAgreeNot sureDisagreeStrongly disagree
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Sponsors are requiring physicians in-house for 24 hours after dosing in some studies
12.50%
18.75%
18.75%25.00%
25.00%
Strongly agreeAgreeNot sureDisagreeStrongly disagree
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Quality Checks are built into every step of our operation
56.25%
18.75%
18.75%6.25%
Strongly agreeAgreeNot sureDisagreeStrongly disagree
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Everyone has a disaster plan Everyone has a formal training program that includes an orientation program for new hires
Across the Board
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Meeting these Challenges
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Recruitment of Patient Population Staff Training Data Queries Security Issues
Some Ideas for Meeting these Challenges
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Consider your facilities – are they conducive to patient studies
Build relationships with medical community◦ Physician to physician◦ Ensure physician retains control◦ Provide the administrative support◦ Sub-I opportunity
Take your research to the patient Local health fairs Community support groups NIH partnerships?
Recruitment of Patient Population
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Suggestions from the Audience
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Build funding into your budgets Training prevents errors – errors cost $$ Annual GCP Training Webinars – one fee for multiple attendees In-house programs
◦ Lunch n Learn◦ Developmental opportunities for presenters
Off-shift training Monthly protocol training PowerPoint Slidesets – specific to clinic activities
Staff Training
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Suggestions from the Audience
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Issues◦ High cost - $80/query◦ Tracking◦ Multiple people involved◦ Documenting
Understand causes◦ Monitor knowledge of site and processes◦ Missing source data◦ Careless error◦ Training◦ Lack of staff◦ Missing source data◦ CRF completion
Data Queries
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QA tracking Analysis of data to identify causes that can be addressed
Create information package for monitors
Present findings from tracking to staff
Training based on identified causes
Data Queries
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Suggestions from the Audience
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On-site security Your reputation can drive subject behavior
Searches Metal detectors Separation of in patient and out patient areas
Security Issues
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Scrubs Lockers away from subject area No cell phones or limited access to cell phones
House Rules Fines for behaviors Be good or be gone
Security Issues
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Suggestions from the Audience
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Revision to the Survey Wider audience Presentation of results to the ACPU board
◦ Can ACPU take a role in helping sites meet some of these challenges?
Explore other avenues for sharing
Next Steps