Clinical Research Management Webinar Series: Results of Huron s Clinical Trials Management System Survey

Transcription

1 Clinical Research Management Webinar Series: Results of Huron s Clinical Trials Management System Survey Wednesday, October 24, :00 p.m. - 1:00 p.m. CT

2 About our speakers Rick Rohrbach Managing Director P rrohrbach@huronconsultinggroup.com Rick advises clients on research management issues with a focus on clinical research planning, operations and compliance. Rick s experience includes facilitating strategic planning efforts for the research enterprise, designing and/or improving the administrative infrastructure supporting research operations, selecting and implementing information systems to support the management of research programs and supporting clients with the assessment and mitigation of regulatory compliance risks. Dan Lodes Director P dlodes@huronconsultinggroup.com Dan has a broad range of clinical and academic systems implementation experience. He is currently working with a large CTSA supported academic medical center on the enterprise-wide implementation of a CTMS. This multiphased implementation includes all clinical research disciplines. The scope of this implementation also includes integration with the institution's EMR and other administrative systems. 2

3 Session Objectives Provide background and context for the survey Present selected survey results Prevalence of clinical trials offices Distribution of administrative support services Adoption and use of CTMS systems Takeaways and Huron tips for improving the CTMS implementation 3

4 About the Survey

5 RESPONSE RATE Survey conducted May 2012 Invitations to participate were sent to 371 institutions Huron received 41 unique responses Response rate of 11% 5

6 RESPONDENT DEMOGRAPHICS Academic Medical Centers (AMCs), including medical schools, make up approximately half of the total respondents. Institution Type Count % of Total AMC (including medical schools) 21 51% Cancer Center 6 15% Community Hospital 5 12% Health System 6 15% Other 3 7% Total % n = 41 6

7 RESPONDENT DEMOGRAPHICS Most respondents reported they have 500 or fewer non-exempt human subjects protocols Institution Count by Number of Studies n = Average studies per site = ,000 1,001-2,000 2,001+ Number of Studies 7

8 RESPONDENT DEMOGRAPHICS The sponsor mix among respondents is relatively evenly distributed. Sponsor Type Average Sponsor Mix at Institution* Federal (NIH, DOD, etc.) 26% Industry (Pharma/Med Device Company) 35% No External Sponsorship 31% Federal 26% No External Sponsorship (internally funded) 31% Other (Patient Advocacy Group, NFPs) 8% Other 8% Industry 35% n = 41 8

9 Polling Question #1 The status of CTMS at my institution is best described by the following statement: We deployed a single CTMS across our enterprise We have one or more CTMS systems but have not implemented across our enterprise We are currently evaluating CTMS options and plan to select and implement a system in the next year We are not using a CTMS and have no plans for the near future but are interested in learning more 9

10 Selected Survey Results Profile and Organization of Respondents

11 CLINICAL TRIALS OFFICE The majority of respondents indicate that their institutions have a central Clinical Trials Office (CTO). Institution Type Count % with CTO AMC (including medical schools) 13 62% Cancer Center 3 50% Community Hospital 4 80% Health System 3 50% Other 2 67% Total 25 61% n = 41 11

12 2011 Survey Comparison PREVALENCE OF CENTRAL CLINICAL TRIALS OFFICES 71% of respondents participating in our 2011 survey reported they had a clinical trials office. Institution Type % with Clinical Trials Office Academic Medical Center 66% Cancer Center 100% Children s Hospital 100% Health System 78% In February 1999, the trade journal CenterWatch 1 estimated that central clinical trials offices had been developed at 11% of the (then) 125 medical schools in the United States. Our survey suggests AMCs have made significant investment in CTOs in the past decade. Other 54% Average 71% n = Centralized AMCs Grow Steadily, CenterWatch Feb; 6(2):

13 CLINICAL TRIALS OFFICE Contracting, budget development and coverage analysis tend to be supported with central resources 100% Central and Department Level Support Central Department n = 41 80% 60% 40% 20% 0% Contract Negotiation Budget Development Coverage Analysis Regulatory Submission Calendars in CTMS Subject Recruitment Type of Service This is also consistent with the results of our 2011 CR Benchmarking Survey. 13

14 CLINICAL TRIALS OFFICE whereas subject recruitment and regulatory submission are performed most frequently by the study teams. 100% 80% Study Team Responsibilities n = 41 60% 40% 20% 0% Subject Recruitment Regulatory Submission Budget Development Calendars in CTMS Coverage Analysis Contract Negotiation Type of Service 14

15 Selected Survey Results CTMS-Specific Responses

16 ADOPTION OF CLINICAL TRIALS MANAGEMENT SYSTEM S About 80% of the respondents indicate their institution is using a CTMS. Of those institutions without a CTMS, many plan to invest in a CTMS in the near future (nearly all are still in the planning stage of system selection). Type of CTMS Count % of Total* Type of CTMS Used Other 9 27% Customized / internally developed software 7 21% Forte Research OnCore 6 18% StudyManager Reveal 5 15% Velos eresearch 3 9% imedris 2 6% Click Commerce CTMS 1 3% Total 33* 100% *5 respondents indicate having more than one type of CTMS. Other 27% Customized / internally developed software 21% Velos eresearch 9% Study Manager Reveal 15% imedris 6% Forte Research OnCore 18% Click Commerce CTMS 3% 16

17 CORRELATION TO SIZE OF PROGRAM Consistent with the results of our 2011 survey, there does not appear to be a correlation between clinical research volumes and the decision to invest in a Clinical Trials Office or a CTMS. Prevalence of a CTO and CTMS by Size of Institution CTO and CTMS Investment CTO CTMS Sites without both 22% Sites with a CTMS and no CTO 17% Sites with a CTO and CTMS 39% ,000 1,001-2,000 2,000+ Number of Studies per Site Sites with a CTO and no CTMS 22% n = 41 17

18 SELECTION PRIORITIES Functionality, price and reputation are the most important decision points when selecting a CTMS. What motivated you to select your current CTMS? n = Priority Non Priority Priority Non Priority Priority Non Priority Priority Non Priority Priority Non Priority Scope of functions Price Reputation/References Compatability with other systems Using vendor for other areas 18

19 FUNCTIONS MOST WIDELY USED Patient tracking, budget development, invoicing, and coverage analysis are the functions most commonly required CTMS functions. Type of CTMS Function Count % of Respondents Patient Tracking 14 74% Budget Development 13 68% Coverage Analysis 12 63% Invoicing 12 63% Registry 8 42% Case Report Forms 6 32% Document Tracking 1 5% What functions of the CTMS are required to be used? n = 19 19

20 MOST FREQUENT POINTS OF INTEGRATION WITH OTHER SYSTEMS 8 of the 23 institutions that reported using a CTMS have interfaced their CTMS with at least one other information system. EMR and IRB systems are the most common touch points. Information System Count EMR 5 IRB 4 Budget Development 2 Coverage Analysis 2 Accounts Receivables 2 General Ledger 2 Human Resources CTMS Interface with Other Information Systems n = 8 20

21 Discussion - CTMS Integration and Data Transfer EXAMPLES FROM OUR CTMS IMPLEMENTATION WORK Opportunities for systems integration and data exchange are numerous and as varied as the portfolio of systems from one institution to another. Electronic Medical Record (EMR) ADT (demographics) interface Typically an HL-7 feed from the EMR to the CTMS. Reduces duplicate data entry and helps ensure patient/subject data integrity among systems Patient Billing Involves the communication of calendar, budget and research vs. standard of care information among the CTMS and EMR/patient billing systems. Approaches range from highly client-customized solutions to those that are more standards-based and vendor-supported. Can reduce or eliminate the need to build the study in two systems. Makes billing compliance more efficient, more effective. Institutional Review Board (IRB) Either a uni or bi-directional sharing of basic study and review information. Can eliminate a large amount of duplicate data entry. 21

22 Discussion - CTMS Integration and Data Transfer EXAMPLES FROM OUR CTMS IMPLEMENTATION WORK Invoicing and Accounts Receivable If the CTMS is capable of generating a sponsor invoice, integration with the institution s A/R and/or G/L system(s) can reduce data entry and ensure data integrity Lab Data Lab results, either from laboratory information system(s) or the EMR can be sent to the CTMS and stored on case report forms Data Feeds to External Agencies Some vendors have developed, or are working on, data extracts to streamline submission of reports (e.g. ClinicalTrials.gov registration, FDA: Medwatch 3500A) Clinical Research Data Repository Cited as a long term goal among some of our clients. Includes the ability to ask complex questions of the data gathered and normalized, primarily from the CTMS and EMR. 22

23 Polling Question #2 Which CTMS interface is your institution most interested in creating? Electronic Medical Record (EMR) Institutional Review Board (IRB) Invoicing and Accounts Receivable Lab Data Data Feeds to External Agencies Clinical Research Data Repository Other 23

24 SCOPE OF IMPLEMENTATION About half of the respondents that indicate CTMS implementation did so institution-wide. One-third of the remaining respondents are in the process of or considering institution-wide implementation. Implementation Level Count % of Respondents Institution-wide 10 53% One or more departments 5 26% 60% 40% CTMS Implementation by Level n = 19 Cancer Center only 4 21% 20% Total % 0% Institution-wide One or more departments Cancer Center only 24

25 LEVEL OF SATISFACTION Although nearly three-fourths of respondents are somewhat or very satisfied with the CTMS, timeliness to implementation is an issue as over half of the institutions experienced delays during the process. Timeliness of Full Implementation (measured as project kick off to go live ) More than 1 year behind schedule *3 AMCs n = months behind schedule 3-6 months behind schedule *1 AMC 7 of these 10 institutions that reported delays were AMCs 0-3 months behind schedule *3 AMCs Completed on time 0-3 months ahead of schedule 3-6 months ahead of schedule Number of Respondents The time taken to fully implement and roll out the CTMS for these 17 respondents ranges from 4 to 48 months. Most suggested the timeline was more than 6 months. 25

26 CLINICAL TRIALS MANAGEMENT SYSTEM More than half of the respondents suggested they would approach the implementation differently if they could do so. Yes No Not sure/still early N/A If you could start over, would you do so? * Number of Respondents Top Reasons 1. Would have secured more support / resources 2. Want to add / change interfaces 3. Would modify the approach for rolling out the system 4. Would invest more in training and change management 5. Would have considered other systems n = 15 * includes changing systems and making specific changes to the current system 26

27 Polling Question #3 For those of you have implemented a CTMS, if you could change one thing about your implementation, what would it be? Would have secured more support / resources Want to add / change interfaces Would modify the approach for rolling out the system Would invest more in training and change management Would have considered other systems Nothing We love our system Other 27

28 SUMMARY OF OPEN ENDED QUESTIONS While respondents indicate flexibility and completeness of their CTMS as the best attributes, they are also concerned with certain functionality features as well as necessary interfacing and support. Selected comments from open responses Best attributes of CTMS Flexibility to customize per study needs Comprehensive system to capture patient and study level data It has grown and been developed with our needs Worst attributes / missing Financial functionality is lacking Connection with other interfaces and systems Ability to be web based; interface budget with study 28

29 Polling Question #4 To achieve the functionality and flexibility we need, our institution prefers 1. To have the ability for my institution to do own customizations 2. To rely on the vendor to deliver the functionality 29

30 IMPLEMENTATION TIPS Pre-implementation Planning Define clear goals / guiding principles Establish metrics to measure progress Consider organizational / policy / workflow impacts Confirm institutional commitment and proper resources to complete the implementation Consider (and prioritize) interface requirements before you start Implementation Define an effective communications plan Understand staffing and support requirements have post-implementation support staff available from beginning of implementation An imperfect system implemented well is better than a perfect system implemented poorly 30

31 Thank you for your participation. For further information, please contact: Rick Rohrbach Managing Director P rrohrbach@huronconsultinggroup.com Dan Lodes Director P dlodes@huronconsultinggroup.com