BEST PRACTICES IN BEST PRACTICES IN STUDY FEASIBILITY

Transcription

1 BEST PRACTICES IN P R E V I E W O F BEST PRACTICES IN STUDY FEASIBILITY A U G U S T,

2 REPORT OVERVIEW 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, 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, and sites to identify the best practices within the feasibility analysis process. DATA COLLECTION IN Q1, MINUTE WEB-BASED SURVEY 101 RESPONDENTS FROM SPONSORS, CROS AND SITES VALUABLE FOR CLINICAL DEVELOPMENT CLINICAL OPERATIONS EXECUTIVE MANAGEMENT 106 PAGES 94 CHARTS AND GRAPHS FEASIBILITY OR SITE SELECTION INVESTIGATORS & SITE MANAGERS THERAPEUTIC AREA HEADS SITE RESEARCH COORDINATORS SITE PRINCIPAL INVESTIGATORS WHAT YOU WILL LEARN The percentage of trials that require a and whether the analysis is conducted in-house or outsourced Objectives for conducting a, the data sources utilized and site selection strategies Awareness of service providers, frequency of use and how well providers performed with respect to client expectations How you can use this report Implement the top techniques and innovations identified by sponsors and for conducting a 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 firm under specific circumstances FOR PHARMA Compare practices with industry peers to identify areas to improve the accuracy of internal and/or outsourced estimations as well as satisfaction with service providers FOR SERVICE PROVIDERS Refine your company s approach to conducting feasibility analyses by implementing the top techniques, innovations and best practices identified by the industry 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 Full Table of Contents on next page.

3 TABLE OF CONTENTS COPYRIGHT AND USAGE GUIDE INTRODUCTION METHODOLOGY FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS Primary Findings Objectives when conducting a Consistency of industry s process Use of SOPs Feasibility analysis site selection strategies Characteristics of a predictive or accurate feasibility estimate Tracking the accuracy of inhouse feasibility estimates Accuracy of feasibility estimates from, sites, and specialized firms Improving feasibility estimates and analysis Top techniques or innovations for feasibility analyses Data sources for in-house feasibility analyses Preferred data sources when using a service provider for SPECIALIZED FEASIBILITY ANALYSIS FIRMS MARKET OVERVIEW Primary Findings Circumstances for contracting a specialized feasibility firm Specialized feasibility firm differentiators FEASIBILITY ANALYSIS SERVICE PROVIDER PERFORMANCE Primary Findings use of feasibility analyses Awareness of service providers Feasibility analysis service provider use Opinion of in-house feasibility analysis capabilities Feasibility analysis service provider performance STUDY DATA Feasibility analysis objectives Characteristics of a predictive or accurate feasibility estimate Consistency of industry s process SOPs for conducting a Tracking the accuracy of inhouse feasibility estimates Feasibility estimate accuracy Percentage of trials that require a Use of outside service providers for Conduct internal feasibility analysis when outsourcing Conduct internal feasibility analysis when using in-house development resources Data sources for in-house Barriers to using EMR data for feasibility estimates Preferred data sources when using a service provider for Opinion of in-house feasibility analysis capabilities Utilization of investigators or coordinators when developing protocols

4 TABLE OF CONTENTS Site selection strategy for Pre-determined site criteria Ranking data sources impact on accuracy Circumstances for contracting a specialized feasibility firm Specialized feasibility firm differentiators Room for improvement in CRO and sponsor feasibility processes Characteristics of different and more effective feasibility processes Feasibility estimate challenges Challenges impact on feasibility estimate accuracy in ranked order Confidence in feasibility estimates Desired improvements to feasibility estimates Best techniques and innovations for feasibility analysis Awareness of service providers capabilities Feasibility analysis service provider use Feasibility analysis service provider performance RESPONDENT PROFILE Organization Type Responsibilities Interaction with functions ABOUT INDUSTRY STANDARD RESEARCH 94 CHARTS AND GRAPHS SAMPLE PAGES

5 SAMPLE PAGE: FEASIBILITY ANALYSIS OBJECTIVES and differ on what they see as the primary objective underlying feasibility analysis. FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS Objectives when conducting a Every component of the analysis has an underlying objective designed to answer the question, What decisions will sponsors,, or sites be able to make once the analysis is complete? and differ on what they see as the primary objective underlying a. cite Determine patient recruitment timelines most often as the primary objective (38%)., however, point to Test the protocol achievability as the primary objective (). 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., 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, 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. ( n=60, n=20) What is your primary objective when conducting a? Please select one. ( n=60, n=20) Primary Objective Objectives - Determine patient recruitment timelines Industry Standard Research - Determine patient recruitment timelines 20% 38% 87% 9 - Test the protocol achievability 28% 7 - Test the protocol achievability 80% - Identify sites for inclusion in the study 27% 88% - Identify sites for inclusion in the study - Determine patient recruitment budget 7% 3 80% 48% -Determine patient recruitment budget 0% 20% 40% 60% 80% 100% % of Respondents Best Practices in Study Feasibility 11 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 (info@isrreports.com). n=20) Primary Objective Objectives - Determine patient recruitment timelines 38% 87% Industry Standard Research - Determine patient recruitment timelines 20% 9 - Test the protocol achievability 28% 7 - Test the protocol achievability 80% - Identify sites for inclusion in the study 27% 88% - Identify sites for inclusion in the study 3 80% - Determine patient recruitment budget 7% 48% -Determine patient recruitment budget 0% 20% 40% 60% 80% 100% % of Respondents CLOSER LOOK << 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:

6 SAMPLE PAGE: CHARACTERISTICS OF A PREDICTIVE OR ACCURATE FEASIBILITY ESTIMATE UNPROMPTED This page shows which attributes and activities contribute to an accurate feasibility estimate from the perspective of sponsors, and sites. The full data is available in the report, which can be downloaded from FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS Characteristics of a predictive or accurate feasibility estimate report the most predictive and accurate feasibility estimates are driven by Prior results in similar clinical studies (). and sites mention this characteristic as well, but less often than having Clear and achievable inclusion and exclusion criteria ( and 4 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. (n=60) (n=20) (n=23) Prior results (with similar patient population, protocol, therapy area) Quality of responses to feasibilty questionnaire (evidence of serious interest, expertise, resources) 17% 2 Industry Standard Research 27% 40% Clear and achievable inclusion and exclusion criteria 2 4 Clear and detailed protocol % Quality of investigator(s) and staff (experienced, interested) 1 1 Discussions with KOLs, thought leaders 8% 10% Discounting stated feasibility estimate 20% Local market knowledge 20% Reasonable time/budget estimates 9% Planning for retention Readily available patients/patient database 20% 17% Viable network of clinical sites 0% 20% 40% 60% 80% % of Respondents Best Practices in Study Feasibility 15 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 (info@isrreports.com).

7 SAMPLE PAGE: BEST TECHNIQUES AND INNOVATIONS FOR FEASIBILITY ANALYSIS UNPROMPTED This page shows responses from sponsors on the best techniques and innovations utilized in their experience with. The full data is available in the report, which can be downloaded from STUDY DATA Best techniques and innovations for In terms of a, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you. (n=60) Applying technology/software No innovations experienced to improving feasibility studies Integrate statistical modeling/knowledge of past performance into feasibility Build time analyses in schedule for administrative/legal/recruiting delays Making direct, personal contact with investigators, sites to build Conducting better relationships patient chart reviews Greater Establishing use of EMR a and preferred other investigator patient databases network Improving Greater feasibility use of EMR survey and (online, other patient more databases specific information) and reporting Seek Improving out input feasibility experienced survey investigators (online, more and specific sites coordinators information) and reporting Increased Increased collaboration collaboration with investigators with investigators on protocol on protocol Integrate statistical modeling/knowledge of past performance Using real-time into feasibility data monitoring analyses Making Applying direct, technology/software personal contact with to investigators, improving feasibility sites to build studies better relationships 2 Industry Standard Research 2 18% 17% 8% 7% 2 More attention Conducting to detail/accuracy patient when chart developing reviews estimates Establishing a preferred investigator network No innovations experienced More attention to detail/accuracy when developing Planning for patient retention estimates Seek Tailoring out input experienced investigators to the and patient sites population coordinators Build time in schedule for Tailoring to the patient administrative/legal/recruiting population delays Planning Using real-time for patient data monitoring retention Using Using social social media to to measure interest 0% 10% 20% 30% % of Respondents Best Practices in Study Feasibility 92 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 (info@isrreports.com).

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10 THE ISR DIFFERENCE act with confidence ISR S REPORTS VS. THE COMMON SYNDICATED REPORT ISR S HEALTH PANEL The industry s fastest growing panel of health care and pharmaceutical professionals, with nearly 1,500 members worldwide. Other 6% CRO 6% Research Site 10% RESEARCH METHODS Mostly primary research; always appropriate for the topic BY COMPANY TYPE One size fits all; usually publically available data Sponsor 78% DATA COLLECTION ISR s proprietary data tools and channels support fast, high quality data collection Struggle to recruit the right targets and enough of them C-level 1 Manager 29% BY JOB LEVEL RESPONDENTS Sophisticated screening ensures genuine decision-makers make up respondents VP 10% Undisclosed methodologies and respondent demographics Director 46% SAMPLE SIZE Robust sample sizes that instill confidence Often insufficient industry representation that leaves you defending results 3-5 years 6-10 years 11% 20+ years 37% BY EXPERIENCE IN YEARS ANALYSTS Decades of experience means more insights that are immediately usable Junior analysts capable of reporting numbers years 24% years Preview of: Benchmarking the Pharma Industry s HEOR Functions 10 To learn more, visit