preview of best practices in study feasibility
TRANSCRIPT
BEST PRACTICESIN STUDY FEASIBILITY A U G U S T , 2 0 1 6
P R E V I E W O F
BEST PRACTICES IN
REPORT OVERVIEW
WHAT YOU WILL LEARN
How you can use this report
One of the primary challenges to successfully completing a clinical study is estimating the medical, clinical, logistical, and regulatory feasibility of the trial. Within the clinical trial feasibility process, sponsors, CROs and sites evaluate the possibility of conducting a clinical trial within a specific geographic region with the overall objective of completing the project with targeted patients and within defined timelines and costs. Thorough feasibility analyses that implement best practices will assist sponsors in delivering successful site start-ups and trials with data from the right patients while finishing on-time and on-budget. ISR gathered opinions from key stakeholders—sponsors, CROs and sites—to identify the best practices within the feasibility analysis process.
D A T A C O L L E C T I O N I N Q 1 , 2 0 1 6
2 0 - M I N U T E W E B - B A S E D
S U R V E Y
1 0 1 R E S P O N D E N T S F R O M S P O N S O R S , C R O S A N D S I T E S
106 PAGES
94 CHARTS AND
GRAPHS
VALUABLE FOR
• The percentage of trials that require a feasibility analysis and whether the analysis is conducted in-house or outsourced
• Objectives for conducting a feasibility analysis, the data sources utilized and site selection strategies
• Awareness of feasibility analysis service providers, frequency of use and how well providers performed with respect to client expectations
• Implement the top techniques and innovations identified by sponsors and CROs for conducting a feasibility analysis
• Improve the accuracy of your own feasibility analyses by learning which characteristics and activities contribute to a predictive feasibility estimate
• Understand the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances
FOR PHARMA
FOR SERVICE PROVIDERS
Compare feasibility analysis practices with industry peers to identify areas to improve the accuracy of internal and/or outsourced estimations as well as satisfaction with service providers
Refine your company’s approach to conducting feasibility analyses by implementing the top techniques, innovations and best practices identified by the industry
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Full Table of Contents on next page.
MAJOR SECTIONS:1. Facilitators & Barriers to
Feasibility Analysis Success
2. Specialized Feasibility Analysis Firms Market Overview
3. Feasibility Analysis Service Provider Performance
4. Study Data
CLINICAL DEVELOPMENT
EXECUTIVE MANAGEMENT
INVESTIGATORS & SITE MANAGERS
THERAPEUTIC AREA HEADS
SITE RESEARCH COORDINATORS
SITE PRINCIPAL INVESTIGATORS
FEASIBILITY OR SITE SELECTION
CLINICAL OPERATIONS
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
TABLE OF CONTENTSCOPYRIGHT AND USAGE GUIDE
INTRODUCTION
METHODOLOGY
FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS
Primary Findings
Objectives when conducting a feasibility analysis
Consistency of industry’s feasibility analysis process
Use of feasibility analysis SOPs
Feasibility analysis site selection strategies
Characteristics of a predictive or accurate feasibility estimate – unprompted
Tracking the accuracy of in-house feasibility estimates
Accuracy of feasibility estimates from CROs, sites, and specialized firms
Sponsors
Improving feasibility estimates and analysis
Top techniques or innovations for feasibility analyses
Data sources for in-house feasibility analyses
Sponsors
CROs
Sites
Preferred data sources when using a service provider for feasibility analysis
Sponsors
SPECIALIZED FEASIBILITY ANALYSIS FIRMS MARKET OVERVIEW
Primary Findings
Circumstances for contracting a specialized feasibility firm – unprompted
Sponsors
CROs
Specialized feasibility firm differentiators – unprompted
Sponsors
FEASIBILITY ANALYSIS SERVICE PROVIDER PERFORMANCE
Primary Findings
Sponsors’ use of feasibility analyses
Awareness of feasibility analysis service providers
Sponsors
CROs
Feasibility analysis service provider use
Sponsors
CROs
Opinion of in-house feasibility analysis capabilities
Feasibility analysis service provider performance
Sponsors
CROs
STUDY DATA
Feasibility analysis objectives
Sponsors
CROs
Characteristics of a predictive or accurate feasibility estimate – unprompted
Sponsors
CROs
Sites
Consistency of industry’s feasibility analysis process
Sponsors
CROs
Sites
SOPs for conducting a feasibility analysis
Tracking the accuracy of in-house feasibility estimates
Feasibility estimate accuracy
Sponsors
Percentage of trials that require a feasibility analysis
Sponsors
Use of outside service providers for feasibility analysis
Sponsors
Conduct internal feasibility analysis when outsourcing
Sponsors
Conduct internal feasibility analysis when using in-house development resources
Sponsors
Data sources for in-house feasibility analysis
Sponsors
CROs
Sites
Barriers to using EMR data for feasibility estimates – unprompted
Sponsors
CROs
Sites
Preferred data sources when using a service provider for feasibility analysis
Sponsors
Opinion of in-house feasibility analysis capabilities
Sponsors
CROs
Sites
Utilization of investigators or coordinators when developing protocols
Sponsors
CROs
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
94CHARTS
AND GRAPHS
SAMPLE PAGES
TABLE OF CONTENTSSite selection strategy for feasibility analysis
Sponsors
CROs
Pre-determined site criteria – unprompted
Sponsors
CROs
Ranking data sources’ impact on accuracy
Sponsors
CROs
Sites
Circumstances for contracting a specialized feasibility firm – unprompted
Sponsors
CROs
Specialized feasibility firm differentiators – unprompted
Sponsors
CROs
Room for improvement in CRO and sponsor feasibility processes
Sites
Characteristics of different and more effective feasibility processes – unprompted
Sponsors
CROs
Sites
Feasibility estimate challenges
Sponsors
CROs
Sites
Challenges impact on feasibility estimate accuracy in ranked order
Sponsors
CROs
Sites
Confidence in feasibility estimates
Sponsors
CROs
Sites
Desired improvements to feasibility estimates – unprompted
Sites
Best techniques and innovations for feasibility analysis – unprompted
Sponsors
CROs
Awareness of service providers’ feasibility analysis capabilities
Sponsors
CROs
Feasibility analysis service provider use
Sponsors
CROs
Feasibility analysis service provider performance
Sponsors
CROs
RESPONDENT PROFILE
Organization Type
Responsibilities
Interaction with functions
ABOUT INDUSTRY STANDARD RESEARCH
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS
11www.ISRreports.com ©2016 Best Practices in Study Feasibility
BEST PRACTICES IN STUDY FEASIBILITY
9
Objectives when conducting a feasibility analysis Every component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis. Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%). CROs, however, point to Test the protocol achievability as the primary objective (45%). In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take. CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed. “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a clinical study sponsor or clinical research organization can forecast and manage the number of patients per site per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all that apply.” (Sponsors n=60, CROs n=20) “What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs n=20)
45%
48%
80%
88%
80%
72%
95%
87%
7%
35%
27%
45%
28%
20%
38%
0% 20% 40% 60% 80% 100%
CROs -Determine patient recruitment budget
Sponsors - Determine patient recruitment budget
CROs - Identify sites for inclusion in the study
Sponsors - Identify sites for inclusion in the study
CROs - Test the protocol achievability
Sponsors - Test the protocol achievability
CROs - Determine patient recruitment timelines
Sponsors - Determine patient recruitment timelines
% of Respondents
Primary Objective Objectives
Objectives when conducting a feasibility analysisEvery component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis� Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%)� CROs, however, point to Test the protocol achievability as the primary objective (45%)� In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take� CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed� “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a
clinical study sponsor or clinical research organization can forecast and manage the number of patients per site
per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all
that apply.” (Sponsors n=60, CROs n=20)
“What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs
n=20)
© Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
S A M P L E P A G E :
FEASIBILITY ANALYSIS OBJECTIVES
Sponsors and CROs differ on what they see as the primary objective underlying feasibility analysis.
C L O S E R L O O K
<< CROs are more likely than sponsors to state the primary objective of a feasibility study is to Test the protocol achievability.
Data available in the full report, which can be found at:
www.ISRreports.com
Introduction
FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS
11www.ISRreports.com ©2016 Best Practices in Study Feasibility
BEST PRACTICES IN STUDY FEASIBILITY
9
Objectives when conducting a feasibility analysis Every component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis. Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%). CROs, however, point to Test the protocol achievability as the primary objective (45%). In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take. CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed. “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a clinical study sponsor or clinical research organization can forecast and manage the number of patients per site per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all that apply.” (Sponsors n=60, CROs n=20) “What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs n=20)
45%
48%
80%
88%
80%
72%
95%
87%
7%
35%
27%
45%
28%
20%
38%
0% 20% 40% 60% 80% 100%
CROs -Determine patient recruitment budget
Sponsors - Determine patient recruitment budget
CROs - Identify sites for inclusion in the study
Sponsors - Identify sites for inclusion in the study
CROs - Test the protocol achievability
Sponsors - Test the protocol achievability
CROs - Determine patient recruitment timelines
Sponsors - Determine patient recruitment timelines
% of Respondents
Primary Objective Objectives
Objectives when conducting a feasibility analysisEvery component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis� Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%)� CROs, however, point to Test the protocol achievability as the primary objective (45%)� In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take� CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed� “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a
clinical study sponsor or clinical research organization can forecast and manage the number of patients per site
per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all
that apply.” (Sponsors n=60, CROs n=20)
“What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs
n=20)
© Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
D A T A I N F U L L R E P O R T
D A T A I N F U L L R E P O R T
D A T A I N F U L L R E P O R T
D A T A I N F U L L R E P O R T
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS
15www.ISRreports.com ©2016 Best Practices in Study Feasibility
Characteristics of a predictive or accurate feasibility estimate – unpromptedSponsors report the most predictive and accurate feasibility estimates are driven by Prior results in similar clinical studies (45%)� CROs and sites mention this characteristic as well, but less often than having Clear and achievable inclusion and exclusion criteria (45% CROs and 43% sites) upon which to base the feasibility estimate� Furthermore, sites mention having a Clear and detailed protocol as the most predictive characteristic (48%)� “In your experience, what makes for a predictive or accurate feasibility estimate? This is one of the key questions
of the study. Please be as specific as possible in your answer. Thank you.”
BEST PRACTICES IN STUDY FEASIBILITY
13
Characteristics of a predictive or accurate feasibility estimate – unprompted Sponsors report the most predictive and accurate feasibility estimates are driven by Prior results in similar clinical studies (45%). CROs and sites mention this characteristic as well, but less often than having Clear and achievable inclusion and exclusion criteria (45% CROs and 43% sites) upon which to base the feasibility estimate. Furthermore, sites mention having a Clear and detailed protocol as the most predictive characteristic (48%). “In your experience, what makes for a predictive or accurate feasibility estimate? This is one of the key questions of the study. Please be as specific as possible in your answer. Thank you.”
17%
9%
13%
48%
43%
17%
20%
5%
20%
20%
10%
5%
25%
45%
40%
25%
2%
2%
2%
3%
5%
5%
8%
13%
22%
22%
27%
45%
0% 20% 40% 60% 80%
Viable network of clinical sites
Readily available patients/patient database
Planning for retention
Reasonable time/budget estimates
Local market knowledge
Discounting stated feasibility estimate
Discussions with KOLs, thought leaders
Quality of investigator(s) and staff (experienced, interested)
Clear and detailed protocol
Clear and achievable inclusion and exclusion criteria
Quality of responses to feasibilty questionnaire (evidence of serious interest, expertise, resources)
Prior results (with similar patient population, protocol, therapy area)
% of Respondents
Sponsors (n=60) CROs (n=20) Sites (n=23)
© Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
S A M P L E P A G E :
CHARACTERISTICS OF A PREDICTIVE OR ACCURATE FEASIBILITY ESTIMATE — UNPROMPTEDThis page shows which attributes and activities contribute to an accurate feasibility estimate from the perspective of sponsors, CROs and sites.
The full data is available in the report, which can be downloaded from www.ISRreports.com.
D A T A I N F U L L R E P O R T
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
STUDY DATA
92www.ISRreports.com ©2016 Best Practices in Study Feasibility
Best techniques and innovations for feasibility analysis – unprompted
Sponsors“In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced?
Please be as specific as possible. Thank you.” (n=60)
BEST PRACTICES IN STUDY FEASIBILITY
88
Best techniques and innovations for feasibility analysis – unprompted Sponsors “In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you.” (n=60)
2%
2%
2%
3%
3%
3%
3%
3%
5%
5%
7%
8%
17%
18%
22%
23%
0% 10% 20% 30%
Using social media to measure interest
Planning for patient retention
Build time in schedule for administrative/legal/recruiting delays
Tailoring feasibility analysis to the patient population
More attention to detail/accuracy when developing estimates
Establishing a preferred investigator network
Conducting patient chart reviews
Applying technology/software to improving feasibility studies
Using real-time data monitoring
Increased collaboration with investigators on protocol
Seek out input experienced investigators and sites coordinators
Improving feasibility survey (online, more specific information) and reporting
Greater use of EMR and other patient databases
Making direct, personal contact with investigators, sites to build better relationships
Integrate statistical modeling/knowledge of past performance into feasibility analyses
No innovations experienced
% of Respondents
© Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
S A M P L E P A G E :
BEST TECHNIQUES AND INNOVATIONS FOR FEASIBILITY ANALYSIS — UNPROMPTEDThis page shows unprompted responses from sponsors on the best techniques and innovations utilized in their experience with feasibility analysis.
The full data is available in the report, which can be downloaded from www.ISRreports.com.
D A T A I N F U L L R E P O R T
D A T A I N F U L L R E P O R T
Applying technology/software to improving feasibility studies
Build time in schedule for administrative/legal/recruiting delays
Conducting patient chart reviews
Establishing a preferred investigator network
Greater use of EMR and other patient databases
Improving feasibility survey (online, more specific information) and reporting
Increased collaboration with investigators on protocol
Integrate statistical modeling/knowledge of past performance into feasibility analyses
Making direct, personal contact with investigators, sites to build better relationships
More attention to detail/accuracy when developing estimates
No innovations experienced
Planning for patient retention
Seek out input experienced investigators and sites coordinators
Tailoring feasibility analysis to the patient population
Using real-time data monitoring
Using social media to measure interest
Introduction
STUDY DATA
92www.ISRreports.com ©2016 Best Practices in Study Feasibility
Best techniques and innovations for feasibility analysis – unprompted
Sponsors“In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced?
Please be as specific as possible. Thank you.” (n=60)
BEST PRACTICES IN STUDY FEASIBILITY
88
Best techniques and innovations for feasibility analysis – unprompted Sponsors “In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you.” (n=60)
2%
2%
2%
3%
3%
3%
3%
3%
5%
5%
7%
8%
17%
18%
22%
23%
0% 10% 20% 30%
Using social media to measure interest
Planning for patient retention
Build time in schedule for administrative/legal/recruiting delays
Tailoring feasibility analysis to the patient population
More attention to detail/accuracy when developing estimates
Establishing a preferred investigator network
Conducting patient chart reviews
Applying technology/software to improving feasibility studies
Using real-time data monitoring
Increased collaboration with investigators on protocol
Seek out input experienced investigators and sites coordinators
Improving feasibility survey (online, more specific information) and reporting
Greater use of EMR and other patient databases
Making direct, personal contact with investigators, sites to build better relationships
Integrate statistical modeling/knowledge of past performance into feasibility analyses
No innovations experienced
% of Respondents
© Industry Standard Research
This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
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Introduction
SMARTER QUESTIONS SMARTER ANSWERS
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ISR’S REPORTS
THECOMMON
SYNDICATEDREPORT
VS.
RESEARCH METHODS
ISR’s proprietary data tools and channelssupport fast, high quality data collection
Struggle to recruit the right targets and enough of them
DATA COLLECTION
Sophisticated screening ensures genuine decision-makers make up respondents
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RESPONDENTS
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SAMPLE SIZE
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Junior analysts capable of reporting numbers
ANALYSTS
ISR’S HEALTH PANELThe industry’s fastest growing panel of health care and pharmaceutical
professionals, with nearly 1,500 members worldwide.
BYJOB
LEVEL
Director 46%
Manager 29%
C-level 13%
VP 10%
BYEXPERIENCE
IN YEARS
16-20 years 23%
11-15years24%
6-10 years 11%
3-5 years 5%
20+ years 37%
BYCOMPANY
TYPE
Other 6%
Sponsor 78%
CRO 6%
ResearchSite 10%