The document discusses a survey conducted at Ohio State University's Comprehensive Cancer Center to improve the process of activating clinical trials. The survey aimed to understand pharmaceutical sponsors' experiences and identify areas for improvement. It found the top strengths were staff professionalism and explanation of roles. The top weaknesses were communication of trial progress, length of activation process, and timeliness of communications. Recommendations to address these weaknesses included using online collaboration tools, setting communication guidelines, and designating direct contacts. Implementing these changes could help provide sponsors more informed trial status updates and clearer, faster communication.

1. Pharmaceutical Sponsor
Engagement Survey to
Improve the Protocol
Activation Process
David Akainda, Trang Bui, Jenna Burg and Morgan Celone
April 14, 2015

2. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
WHY IS THIS IMPORTANT?
The single most important mission for a
Comprehensive Cancer Center
is
CLINICAL CANCER RESEARCH
2

3. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
Our James Board Level Goal
Reduce Time to Trial to 3-4 months
for all therapeutic clinical trials
3

4. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
Clinical Trial Development Process
A JOURNEY
4
Basic Research
Homegrown Science
Industry Partners NCI Co-operative
Groups
PROTOCOL IS DEVELOPED
PROTOCOL APPROVAL PROCESS
PROTOCOL OPENS AND BENEFITS PATIENTS
PROTOCOL ACTIVATION PROCESS

5. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0.16
Actual Response Rate Desired Response Rate
ResponseRate
Response Rate After 1st E-Mail
SURVEY COLLECTION
Response
Rate: 4/95
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0.16
Actual Response Rate Desired Response Rate
ResponseRate
Response Rate After 2nd E-
Mail
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0.16
Actual Response Rate Desired Response Rate
ResponseRate
Response Rate After 3rd E-
Mail
Response
Rate: 6/95
Response Rate:
13/95
Introduction email
explaining the
survey

6. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
DATA ANALYSIS: An overall view
Highest average:
Biggest strength
Lowest average:
Biggest weakness

7. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
7
1. Staff professionalism (AV 4.38)
2. Staff receptivity to the sponsor role/responsibility (AV 4.25)
3. Staff explanation of their role/responsibility (AV 4.23)
Top Three Strengths

8. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
1. Communication of protocol progress (AV 3.23)
2. Length of activation process (AV 3.31)
3. Timeliness of communications (AV 3.54)
8
Top Three Weaknesses

9. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
“Staff collaborated very well with us to activate the
protocol in a timely manner.”
“I liked that there are people specialized in roles.”
“Too many people are involved and there seems to be
very little internal communication”
9
Sponsor Comments

10. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
Analyze each
individual area
identified as
needing
improvement
List 6-10
suggestions
for
improvement/r
esources
needed
Use priority
scale (ease,
cost, impact)
to identify top
3 improvement
strategies
Lowest
number =
highest priority
strategy
10
IMPROVEMENT STRATEGY

11. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute 11
Top Recommendations
Length of Activation Process
Improvement Strategy Resources
Ease with
which to
Implement
(1 is easy)
Cost
(1 is least
expensive)
Impact on
Overall
Process (1
is high)
Priority
Scale
(AxBxC)
Have the Protocol in a
form which can be
accessible online via
computers, smart phones,
tablets etc. when
changes/updates occur
(similar to Google docs). It
enables proper handover
of crucial information and
sponsors get updated
frequently at the same
time.
Software,
IT
specialist
2 4 2 16

12. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute 12
Top Recommendations
Communication of Protocol Progress
Improvement Strategy Resources
Ease with
which to
Implement
(1 is easy)
Cost
(1 is least
expensive)
Impact on
Overall
Process
(1 is high)
Priority
Scale
(AxBxC)
At initial activation of
process, set up ground
rules and a weekly
conference to
communicate by email,
phone, teleconference
etc. so that both sides
know when something is
urgent and can easily
receive crucial updates.
Phone/Com
puter,
Conference
Site
2 1 1 2

13. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute 13
Top Recommendations
Timeliness of Communications
Improvement Strategy Resources
Ease with
which to
Implement
(1 is easy)
Cost
(1 is least
expensive)
Impact on
Overall
Process
(1 is high)
Priority
Scale
(AxBxC)
Having a direct person to
contact for all types of
communications. By
doing this roundabout
emails/calls will be
avoided and the best
person to answer all
questions/concerns will
immediately be
contacted.
Person to
Take on
Role, Chart
Containing
Contact
Information
2 1 2 4

14. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
Pharmaceutical Sponsor The James
• More Informed at Each Step
• Trials Opening Quicker
• Clearer Communications
• Faster Communications
• More likely to Work with The James
in the Future
• Improved Relationship with The
James
• Less Redundancies in Activation
Process
• “Experts” Trained to Answer
Questions
• Clearer Communications
• Faster Communications
• Quicker Turn Over Process
• Standardized Work Flow
• Improved Relationship with
Pharmaceutical Sponsors
14
Impact

15. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute 15
LESSONS LEARNED
• Limitations
• The advantages/disadvantages of table-
topping vs. speaking to stakeholders directly
• Importance of titles in communication with people
outside of the organization
• Refining the distribution sample before sending
out the survey
• Earlier introduction of the incentive during our
survey distribution
• Importance of a high survey response rate

16. The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove
Research Institute
NEXT STEPS
16
Present improvement strategies based off of
our prioritization to Clinical Trials Leadership
Staff to see the possibility of implementation.
NEXT STEPS