The State of Clinical
Outsourcing:
Impact of Outsourcing
Partnerships on Clinical Trial
Optimization
Data from the
2014 Av...
2
Denise Calaprice-Whitty, Ph.D. (Moderator)
Senior Consultant, The Avoca Group
Coleen Glessner
VP, Clinical Trial Process...
3
2014 Avoca Industry Survey
Big Question:
How are “intelligent,” data-driven
approaches* being used in clinical
developme...
4
Background: 2014 Avoca Industry Survey
Why now?
╸ “Big Data” concepts have become part of our daily experience
╸ Success...
5
●  Areas of opportunity, examples:
╸ overall protocol design, e.g. adaptive study designs, i.e. those adjusted
during th...
6
●  Therefore, the 2014 Avoca Industry Survey explored the impact of
outsourcing relationships on this area.
●  Specific ...
7
●  Sponsors: 127 Respondents
╸ Approximately 45% in top 20 in terms of revenue
o  67% Pharma
o  28% Biotech
o  3% Device...
8
Results: Application of Approaches
How frequently are “intelligent”
approaches applied?
How much advancement has
been ma...
9
% of Respondents Reporting that Most of their Clinical Trials Use “Intelligent”
Approaches
(activities performed by the ...
10
% of Respondents Reporting at least “Moderate Advances” in the Use of
“Intelligent” Approaches over the Last 2 years
(a...
11
% of Respondents Reporting “Great Advances” in the Use of “Intelligent”
Approaches over the Last 2 years
(activities pe...
12
For each of your in-house teams and your clinical service providers, please rate
your levels of satisfaction (1 to 5) w...
13
Results: Rate of Advancement
Which aspects of progress have
depended (positively or negatively)
on outsourcing relation...
14
Contributions of Service Providers: Sponsors
In your opinion, to what extent do your company's clinical service provide...
15
Do Partnerships Promote or Impede?
Sponsors Providers
Availability of data X
X
X
X
X
X
X
X
X
X
X
X
Availability of mode...
16
Do Partnerships Promote or Impede?
Sponsors Providers
External pressures
X
X
X
X
X
X
X
X
X
X
X
X
Resources
X
X
X
X
X
X
...
17
Do Partnerships Promote or Impede?
Sponsors Providers
Change management issues
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to ...
18
Sponsor and Provider Data
Has your company implemented any specific change management initiatives to
help accelerate/im...
19
Sponsor and Service Provider Verbatim
●  Increased resourcing in this area, creation of new roles (and/or service offer...
20
Key Take-Aways
●  Abundant opportunities exist for the application of “intelligent,” data-driven
approaches in clinical...
Thank you
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princet...
Upcoming SlideShare
Loading in …5
×

Partnerships in Clinical Trials 2014

555 views

Published on

The State of Clinical Outsourcing: Impact of Outsourcing Partnerships on Clinical Trial Optimization

Published in: Health & Medicine, Business
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
555
On SlideShare
0
From Embeds
0
Number of Embeds
19
Actions
Shares
0
Downloads
13
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Partnerships in Clinical Trials 2014

  1. 1. The State of Clinical Outsourcing: Impact of Outsourcing Partnerships on Clinical Trial Optimization Data from the 2014 Avoca Industry Survey Partnerships in Clinical Trials
  2. 2. 2 Denise Calaprice-Whitty, Ph.D. (Moderator) Senior Consultant, The Avoca Group Coleen Glessner VP, Clinical Trial Process & Quality, Pfizer Jamie MacDonald CEO, Clinical Services, INC Research Marisa Co Vice President, BMS Panel Members Graeme Currie, Ph.D. Vice President, Clinical Project Management and Operations, Regeneron Pharmaceuticals
  3. 3. 3 2014 Avoca Industry Survey Big Question: How are “intelligent,” data-driven approaches* being used in clinical development today? What factors promote their use, and what factors inhibit it? *For the purpose of this survey, an “intelligent,” data-driven approach was defined as one that makes use of operational (e.g. performance) and/or clinical data, along with appropriate analytical techniques, in order to optimize aspects of clinical development such as protocol design, Investigator selection, patient recruitment approaches, resource allocation (e.g. risk-based monitoring), etc.
  4. 4. 4 Background: 2014 Avoca Industry Survey Why now? ╸ “Big Data” concepts have become part of our daily experience ╸ Successful and highly visible use in other industries o  Moneyball o  Netflix o  Credit companies o  Facebook ╸ Clear opportunity in our industry ╸ Unprecedented availability and aggregation of digital information ╸ Even further promoted by high rates of outsourcing ╸ Continued time, cost, and quality pressures ╸ Easy to imagine areas of opportunity
  5. 5. 5 ●  Areas of opportunity, examples: ╸ overall protocol design, e.g. adaptive study designs, i.e. those adjusted during the course of a study based on biomarker or clinical study data gathered during the study ╸ procedural or eligibility aspects of protocols, e.g. examination of data from previous studies to identify procedures/criteria associated with high levels of protocol violations, cost, screen failures, etc. vs. value of the data received ╸ selection of sites, regions, providers, or patient recruitment approaches, e.g. use of performance databases to identify optimal selection for a given function or study ╸ project management/oversight , e.g. data- or formula-based identification of areas/periods of low/high risk, in order to allocate oversight resources accordingly. As with any change, however, companies must recognize and effectively manage the forces that impact uptake and success. Background: 2014 Avoca Industry Survey
  6. 6. 6 ●  Therefore, the 2014 Avoca Industry Survey explored the impact of outsourcing relationships on this area. ●  Specific research questions included: ╸ How frequently are “intelligent” approaches applied to each key area? Among sponsors, how and why does this differ for in-house vs. outsourced activities? ╸ How much advancement has been made over the last 2 years? ╸ How satisfactory are the results that are being seen? ╸ What forces have contributed to advancement, and what has impeded it? What has been the impact of outsourcing partnerships? ╸ Experience with technology, training, and other implementation and change management solutions ╸ Early engagement of partners in protocol and development planning: Do you do it? Does it promote use of “intelligent” approaches? Does it improve quality? How? ╸ Is the use of intelligent approaches impacted by the outsourcing model employed (strategic vs. transactional, full-service vs. FSP)? Background: 2014 Avoca Industry Survey
  7. 7. 7 ●  Sponsors: 127 Respondents ╸ Approximately 45% in top 20 in terms of revenue o  67% Pharma o  28% Biotech o  3% Device o  2% Combination/Other ●  Clinical Service Providers: 105 Respondents ╸ 64% in top 20 in terms of revenue o  67% CROs o  33% Other/Niche Respondents 2014 Avoca Industry Survey: Respondents
  8. 8. 8 Results: Application of Approaches How frequently are “intelligent” approaches applied? How much advancement has been made over the last 2 years? How satisfactory have been the results? Questions 1, 2, and 3
  9. 9. 9 % of Respondents Reporting that Most of their Clinical Trials Use “Intelligent” Approaches (activities performed by the respondent’s company) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Region selection Site selection Cost benchmarking/management Provider selection Project management/oversight Protocol procedures/eligibility Data collection tools Overall protocol designs Patient/volunteer recruitment Monitoring (e.g. risk-based) Sponsors (N=87) Providers (N=62) Results: Application of Approaches
  10. 10. 10 % of Respondents Reporting at least “Moderate Advances” in the Use of “Intelligent” Approaches over the Last 2 years (activities performed by the respondent’s company) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Site selection Provider selection Region selection Data collection tools Monitoring Project management/oversight Protocol procedures/eligibility criteria Overall protocol designs Cost benchmarking/management Sponsors (N=84) Providers (N=65) Results: Rate of Advancement
  11. 11. 11 % of Respondents Reporting “Great Advances” in the Use of “Intelligent” Approaches over the Last 2 years (activities performed by the respondent’s company) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Site selection Monitoring Data collection tools Provider selection Patient/volunteer recruitment Overall protocol designs Region selection Project management/oversight Specific protocol procedures or eligibility criteria Sponsors (N=84) Providers (N=65) Results: Rate of Advancement
  12. 12. 12 For each of your in-house teams and your clinical service providers, please rate your levels of satisfaction (1 to 5) with the application of "intelligent" (data- driven) approaches on your projects, in each of the below areas. Satisfaction with“Intelligent” Approaches   Sponsor ratings Clinical service provider self ratings  In-house teams Clinical service providers N= 65 54 54 Overall protocol designs (e.g. adaptive) 3.4 2.9 3.8 Specific protocol procedures or eligibility criteria 3.4 3.0 3.7 Site selection 3.3 3.1 3.9 Region selection 3.4 3.3 3.7 Provider selection 3.4 2.9 3.4 Patient/volunteer recruitment 3.2 3.1 3.6 Data collection tools (e.g. designs associated with lowest query rates) 3.4 3.3 3.7 Monitoring (e.g. risk-based monitoring) 3.1 3.1 3.5 Other operational processes 3.2 3.1 3.4 Cost benchmarking/management 3.3 2.5 3.2 Project management/oversight 3.4 3.0 3.4
  13. 13. 13 Results: Rate of Advancement Which aspects of progress have depended (positively or negatively) on outsourcing relationships, and to what extent? What types of change management initiatives have made a positive difference? Questions 4 and 5
  14. 14. 14 Contributions of Service Providers: Sponsors In your opinion, to what extent do your company's clinical service providers either contribute to, or detract from, your company's use of "intelligent" clinical development approaches? 19% 14% 21% 22% 7% 15% 4% 7% 3% 7% 50% 43% 37% 35% 37% 29% 36% 31% 26% 21% 26% 27% 35% 32% 36% 36% 41% 50% 40% 52% 46% 39% 3% 6% 7% 6% 13% 15% 11% 20% 20% 26% 26% 1% 1% 4% 1% 6% 2% 9% 0% 20% 40% 60% 80% 100% Site selection Region selection Monitoring (e.g. risk-based monitoring) Patient/volunteer recruitment Project management/oversight Data collection tools Other operational processes Provider selection Specific protocol procedures or eligibility criteria Overall protocol designs (e.g. adaptive) Cost benchmarking/management Essential contribution Significant contribution Little contribution No contribution Negative contribution N 70 69 73 72 67 68 56 55 66 57 57
  15. 15. 15 Do Partnerships Promote or Impede? Sponsors Providers Availability of data X X X X X X X X X X X X Availability of models and experience Understanding of regulatory perspective Technology X X X X X X X X X X X X Contributors to Advancement Principal Contributors to Advancement
  16. 16. 16 Do Partnerships Promote or Impede? Sponsors Providers External pressures X X X X X X X X X X X X Resources X X X X X X X X X X X X Contributors to Advancement Principal Contributors to Advancement
  17. 17. 17 Do Partnerships Promote or Impede? Sponsors Providers Change management issues X X X X X X X X X X X X Contributors to Advancement Principal Contributors to Advancement
  18. 18. 18 Sponsor and Provider Data Has your company implemented any specific change management initiatives to help accelerate/improve the adoption of "intelligent" approaches to clinical trial design and execution? 55% 63% 45% 37% 0% 20% 40% 60% 80% 100% Sponsors Clinical Service Providers Yes No N 69 52
  19. 19. 19 Sponsor and Service Provider Verbatim ●  Increased resourcing in this area, creation of new roles (and/or service offerings) with targets and accountability ●  SOPs and process improvements, including joint sponsor-provider ●  New technology ●  Better data collection, review, analysis skills and tools ●  Enhanced partnering/subcontracting initiatives ●  Surveys to assess status and changes ●  “Ambassador” programs ●  Intensive and detailed training initiatives ●  Broad employee engagement in designing changes ●  Measurement of impact/ROI; case studies to show benefits ●  Encouraging full risk assessment so that efforts are focused in the right place Ø  Importance of global initiatives supported by senior management If "Yes", please briefly describe initiative and impact.
  20. 20. 20 Key Take-Aways ●  Abundant opportunities exist for the application of “intelligent,” data-driven approaches in clinical development. ●  Many people believe that their companies have made substantial progress in this area over the last two years. ●  Outsourcing relationships may enhance uptake of such approaches, principally by increasing access to aggregated data, expertise, and experience. ●  However, outsourcing relationships may also present challenges to uptake, in the form of issues with change management and/or coordinated planning, and in some cases, potential conflicts of interest. Key Take-Aways
  21. 21. Thank you Contact Avoca at: (609) 252-9020 www.theavocagroup.com info@theavocagroup.com 179 Nassau Street Suite 3A Princeton, NJ 08542

×