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Assessing Clinical Research Infrastructure Needs
 

Assessing Clinical Research Infrastructure Needs

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This report summarizes the results of a campus-wide survey initiative, conducted by the Southern California Clinical and Translational Science Institute (SC CTSI), focused on the development of a ...

This report summarizes the results of a campus-wide survey initiative, conducted by the Southern California Clinical and Translational Science Institute (SC CTSI), focused on the development of a clinical data warehouse for research (CDWR) and a clinical trials management system (CTMS) as well as general barriers to conducting clinical research at the University of Southern California (USC) and Children's Hospital Los Angeles (CHLA).
Learn more about SC CTSI http://www.sc-ctsi.org/

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    Assessing Clinical Research Infrastructure Needs Assessing Clinical Research Infrastructure Needs Presentation Transcript

    • May 2013 Authors: Allison Orechwa, Ph.D. Melanie Funes, Ph.D. Susan Autry, MBA CLINICAL RESEARCH INFRASTRUCTURE NEEDS SURVEY RESPONSE REPORT Responses from USC Health Sciences Faculty and Staff
    • www.sc-ctsi.org | Page 2 3 Executive Summary 4 Introduction 5 Describing the Sample 7 Clinical Data Warehouse for Research 10 Clinical Trials Management System 11 Biorepository 12 Southern California Clinical and Translational Science Institute 14 Perceived Challenges in Conducting Clinical Research 16 Appendix A: Full Survey 22 Appendix B: CDWR – Other Types of Data 23 Appendix C: CDWR – Other Feedback and Concerns 25 Appendix D: CTMS – Other Feedback and Concerns 26 Appendix E: All Perceived Challenges Table of Contents
    • www.sc-ctsi.org | Page 3 Executive Summary 139 volunteers There is significant interest across the USC enterprise in the development of a clinical data warehouse for re- search (CDWR) and a clinical trials management system (CTMS). This survey was created to gather input from potential users in order to inform the development of these new tools. Selected findings include: The biggest perceived challenges among the clinical research community are: Administrative hurdles (men- tioned by 26% of faculty respondents), Funding (24%), Access to clinical data or specimens (21%), and Clinical research support staff (21%). Ninety percent of faculty respondents said that having access to clinical data from the Keck Medical Center is important to their research; 57% said access is criti- cally important. Eighty-oneofthe126faculty(64%)indicatedthatusing the CDWR for Historical data extraction for retrospec- tive studies was critically important to their research. The next most highly rated purposes were Health out- comes research (48%) and Identification of potential participants in on-going or planned clinical trial (42%). Of the different types of data that could be included in a CDWR, five were rated as Critically Important by at least 50% of faculty: Demographics, Diagnoses, Proce- dures, Laboratory test results, and Outcomes. The highest-rated capabilities of a CTMS, in terms of importance to faculty research, were Patient Manage- ment and Biorepository Management (44% and 40% of faculty selected Critically Important, respectively). The top two components according to staff were Pa- tient Management and Study Management (63% each). Thirty-five percent of faculty rated a structured biore- pository as Important to their research, and 38% rated it as Critically Important. When asked about resources and services offered by the Southern California Clinical and Translational Science Institute, over 50% of faculty rated pilot fund- ing, informatics consultations, and assistance in the design, conduct, and management of human studies as Important or Critically Important to their research. Seventy percent of respondents (139 individuals) said they want to be involved at some level (i.e., participat- ing in working or advisory groups) in the development of the CDWR or the CTMS. “Development of a useful and accessible data- base is critical to my research.” - USC health sciences faculty member
    • www.sc-ctsi.org | Page 4 Introduction Purpose There is significant interest across the USC enterprise in the development of a clinical data warehouse for research (CDWR) and a clinical trials management system (CTMS), which are essential to providing clin- ical trial data management solutions and enhancing the competitiveness and impact of clinical research at USC. This survey was created to gather input from potential users in order to inform the development of these new tools, including their functionality and in- tended use. The survey was broadened to also identify the biggest challenges in conducting clinical research and assess the importance of existing and potential clinical and translational research infrastructure. Survey Development SC CTSI staff worked with faculty researchers, senior university leadership, and other representatives of the clinical and translational science community to de- velop the survey. The final survey contained questions pertaining to a CDWR, a CTMS, and general needs for clinical research infrastructure, with the hope that a single set of responses would serve multiple efforts. See Appendix A for the full survey. Audience The intended audience for the survey was all faculty and staff at USC and its partner institutions who conduct or support clinical and translational research (staff responses were excluded from the CDWR and biorepository analyses because those questions per- tained mostly to faculty). The survey was therefore distributed via email listservs to the following groups: faculty and staff in the Schools of Medicine, Dentistry, Gerontology, Pharmacy, Public Policy, and Social Work; the Biomedical Engineering department within the School of Engineering; the USC Norris Compre- hensive Cancer Center; Children’s Hospital Los Ange- les. A few key groups were also contacted directly by SC CTSI’s director, including investigators who were previously served by SC CTSI. USC Health Sciences Medicine Dentistry Gerontology Pharmacy Public Policy Social Work Biomedical Engineering
    • www.sc-ctsi.org | Page 5 Describing the Sample Of the 201 individuals who completed the survey, 127 were faculty, 63 were staff, and 11 were “other” (e.g., student, adjunct instructor). When asked to indicate their role and primary activity, 12% of respondents selected Basic researcher, 24% selected Clinician researcher (>15% spent on research), and 11% selected Translational researcher. Forty of the 63 staff respon- dents (63%) selected Clinical research support as their role and primary activity. The majority of respondents were located on the Health Science Campus and affili- ated with the School of Medicine. The sample includes 94faculty who conduct research at USC. Role Number of Respondents % of Total Faculty 127 63% Rank Assistant Professor 52 26% Associate Professor 28 14% Professor 42 21% Other or No Response 5 2% Primary Activity Basic researcher 24 12% Clinician (0 15% spent on research) 28 14% Clinician researcher (>15% spent on research) 48 24% Translational researcher (early stage development) 22 11% Device development 6 3% Drug development 5 2% Other or No Response 11 5% Other or No Response 5 2% Staff 63 31% Primary Activity Clinical research support 40 20% Other research support 18 9% Other or No Response 5 2% Other 11 5% Total 201 100%
    • www.sc-ctsi.org | Page 6 Describing the Sample (cont’d.) Number of Respondents % of Total Number of Respondents % of Total Campus USC Health Sciences Campus 81 40% 53 26% USC University Park Campus 17 8% 6 3% CHLA Children's Hospital Los Angeles 25 12% 2 1% Other or No Response 4 2% 2 1% School Dentistry (including Physical and Occupational Therapy) 14 7% 4 2% Engineering (Biomedical Engineering only) 5 2% Gerontology 4 2% 3 1% Medicine 94 47% 38 19% Pharmacy 5 2% 3 1% Social Work 5 2% 1 0% Other or No Response 14 7% Cancer Center Affiliation Yes 42 21% 32 16% No 84 42% 31 15% Affiliation Faculty Staff
    • www.sc-ctsi.org | Page 7 64% of faculty say historical data ex- traction from a CDWR is critically important to their research. Clinical Data Warehouse for Research CDWR purposes Following a brief description of a clinical data ware- house for research (CDWR), respondents were asked, “For what purpose(s) would you use a clinical data warehouse?” They were instructed to rate each pur- pose in terms of its importance to their research (Would Not Use It for This Purpose, Minimally Im- portant, Important, or Critically Important/Essential). Eighty-one of the 126 faculty who responded to the question (64%) indicated that using the CDWR for Historical data extraction for retrospective studies was Critically Important to their research. The next most highly rated purposes were Health outcomes research (48%) and Identification of potential participants in on-going or planned clinical trial (42%). All other options provided were rated as either Important or Critically Important by at least 50% of faculty respon- dents. A number of respondents added purposes of their own in an “Other” field, including Decision support; Education for Keck and informatics students; Initiat- ing new studies using the same database and speci- mens if available; IRB; Patient information for labo- ratory medicine research; Physiology, mechanisms; Prospective etiologic research; Systematic reviews; Access to MRI neuroimaging images. Purpose (Total Responses) Would Not Use It for This Purpose Minimally Important Important Critically Important 8 12 25 81 6% 10% 20% 64% 13 20 33 60 10% 16% 26% 48% 13 23 37 53 10% 18% 29% 42% 30 21 30 42 24% 17% 24% 34% 20 20 44 37 17% 17% 36% 31% 27 25 38 35 22% 20% 30% 28% 28 27 36 34 22% 22% 29% 27% 24 25 44 32 19% 20% 35% 26% Precision/personalized medicine (125) Health access disparities research (125) Historical data extraction for retrospective studies (126) Health outcomes research (126) Identification of potential participants in on going or planned clinical trial (126) Quality healthcare research (123) Health effectiveness research (121) Health economics/cost effectiveness research (125)
    • www.sc-ctsi.org | Page 8 Clinical Data Warehouse for Research CDWR types of data Using the same rating system, survey respondents were next asked to rate 23 different types of data that could be included in a CDWR. Five data types were rated as Critically Important by at least 50% of fac- ulty: Demographics, Diagnoses, Procedures, Laboratory test results, and Outcomes. The table below presents the combined number and percentage of faculty who rated each data type as either Important or Critically Important. Appendix B contains all responses to the open-ended “Other types of data” item. Type of Data (Total Responses) Diagnoses (ICD 9/10) (126) 116 92% Outcomes (124) 114 92% Demographics (125) 110 88% Medications (126) 110 87% Laboratory test results (124) 105 85% Procedures (CPT) (123) 102 83% Radiology reports (123) 95 77% Elements of physical exam other than vital signs (122) 83 68% Pathology reports (125) 84 67% Family history (125) 84 67% Elements of physical exam vital signs (123) 82 67% Images (122) 80 66% Genetic/genomic data (123) 79 64% Smoking status (125) 77 62% Physician notes (121) 74 61% Bio repository data (124) 74 60% Drug/Alcohol use (123) 73 59% Stage (for cancer diagnoses) (123) 71 58% Financial/cost data (122) 70 57% Review of Systems (120) 68 57% Other text in medical records (115) 51 44% Insurance coverage (123) 54 44% Allergies (125) 44 35% Important or Critically Important 0% 25% 50% 75% 100%
    • www.sc-ctsi.org | Page 9 Clinical Data Warehouse for Research CDWR sources of data Respondents were asked to rate the importance of having access to clinical data from the following sources: Keck Medical Center of USC, Children’s Hos- pital Los Angeles (CHLA), Los Angeles County Hos- pital (LAC+USC), and the Los Angeles County public health system (DHS). Both Keck Medical Center and LAC+USC were rated as Critically Important by 57% of faculty respondents. When asked, “In addition to hospital electronic medi- cal records, pharmacy records, lab data, and finan- cial systems, are there other sources of data that you would like to see ultimately included in the CDWR,” the majority of respondents checked Cancer Registry (63%) and Death Registry(ies) (72%). Other types of sources provided by the respondents include Dis- ability and Social Services Registry; Chronic Disease Registry; Obesity and diabetes registry; Rehabilitation reports and data; Patient satisfaction data; Brain im- ages. Source (Total Responses) Would not use Minimally Important Important Critically Important 12 12 29 71 10% 10% 23% 57% 25 15 25 54 21% 13% 21% 45% 10 11 33 71 8% 9% 26% 57% 19 18 33 41 17% 16% 30% 37% Keck Medical Center (124) CHLA (119) LAC+USC (125) DHS (111) Registry Type Number of responses* % of total Cancer Registry 55 63% Cardio Registry 30 34% Death Registry(ies) 63 72% * Multiple selections possible
    • www.sc-ctsi.org | Page 10 Clinical Trials Management System CTMS capabilities The next section of the survey pertained to a clini- cal trials management system (CTMS). Respondents were presented with six broad components or capa- bilities of a CTMS and asked to rate each in terms of its importance to their research. Patient Management and Biorepository Management received the highest ratings from faculty (44% and 40% selected Critically Important, respectively), whereas the top two compo- nents according to staff were Patient Management and Study Management (63% each). Sixty percent of staff rated a Financial Management component as either Important or Critically Important . Capability Respondent Type (Total Responses) Would not use Minimally Important Important Critically Important 11 21 43 48 9% 17% 35% 39% 3 5 14 38 5% 8% 23% 63% 28 26 41 28 23% 21% 33% 23% 12 12 10 27 20% 20% 16% 44% 13 20 36 55 10% 16% 29% 44% 2 6 14 38 3% 10% 23% 63% 12 24 39 48 10% 20% 32% 39% 3 3 19 34 5% 5% 32% 58% 22 17 35 50 18% 14% 28% 40% 8 5 22 27 13% 8% 35% 44% 23 19 33 46 19% 16% 27% 38% 7 5 22 25 12% 8% 37% 42% Study Management (protocol tracking; enrollment tracking; study calendar) Faculty (123) Staff (60) Financial Management (study budgeting; Medicare coverage analysis; invoicing) Faculty (123) Staff (61) Patient Management (patient enrollment, identification, and randomization; scheduling; eligibility tracking; adverse event tracking) Faculty (124) Staff (60) Report and Data Management (electronic case reports; data reporting and export tools) Faculty (123) Staff (59) Biorepository Management (specimen and result tracking; inventory management) Faculty (124) Staff (62) Importing current clinical study data from my existing database(s) Faculty (121) Staff (59)
    • www.sc-ctsi.org | Page 11 Biorepository Of the 127 faculty who responded to the item, “Please rate the importance to your research of having a structured biorepository,” 19 selected “Would Not Use,” 16 selected “Minimally Important,” 44 selected “Important,” and 48 selected “Critically Important.” 85% of faculty said they would use a biorepository. Would Not Use 15% Minimally Important 13% Important 35% Critically Important 38%
    • www.sc-ctsi.org | Page 12 Southern California Clinical and Translational Science Institute SC CTSI resources and services Respondents were next asked to rate existing and potential future clinical research infrastructure. The types of services that received the highest ratings from faculty were pilot funding; informatics consul- tations; and assistance in the design, conduct, and management of human studies. The two “under con- sideration” resources or services were each rated as Important or Critically Important by the majority of respondents (Clinical research coordinator core: 66%; Participant recruitment service: 71%). Would not use Minimally Important Important Critically Important 6 11 23 76 5% 9% 20% 66% 17 16 30 51 15% 14% 26% 45% 8 11 32 72 7% 9% 26% 59% 9 12 32 70 7% 10% 26% 57% 9 21 45 49 7% 17% 36% 40% 11 24 42 44 9% 20% 35% 36% 17 21 44 41 14% 17% 36% 33% 15 21 49 38 12% 17% 40% 31% 14 23 49 36 11% 19% 40% 30% 17 27 43 36 14% 22% 35% 29% 24 34 41 23 20% 28% 34% 19% 27 33 38 21 23% 28% 32% 18% 22 34 48 18 18% 28% 39% 15% 18 23 36 46 15% 19% 29% 37% 11 24 45 42 9% 20% 37% 34% RESOURCES & SERVICES (TOTAL RESPONSES) CURRENTRESOURCES&SERVICES PILOT FUNDING (116) CLINICAL RESEARCH SPACE AND SERVICES (114) CONSULTATIONS Biostatistics (123) Statistical analysis (123) Data management (124) Study design (121) Bioinformatics (123) UNDER CONSIDERATION CLINICAL RESEARCH COORDINATOR CORE (123) PARTICIPANT RECRUITMENT SERVICE (122) Conducting and managing human studies (123) Regulatory knowledge and support (122) Translation of preclinical discoveries (123) Scientific writing (122) Community engaged research (119) Research ethics (122)
    • www.sc-ctsi.org | Page 13 • A clinical research coordinator core would be extremely helpful for a biological / biomarker study we are trying to get off the ground. A core - which could charge for their expertise in coordinating such activities - would be a great help. • Access to trained clinical coordinators would be extremely helpful. • Artificial intelligence machine learning big data management • Data core: Need experience and help from someone working with the data on a daily basis to assist in producing extracts and analytic data files. • I don't get out enough - I could use help networking • I have good coordinators, but it would be a very valuable resource for the institution overall. • One-stop service to submit request for obtaining clinical data and/or biorepository specimens from USC study sites (Keck, CHLA, LAC-USC, etc) • Really need to improve access to bioinformatics experts. This is a major bottleneck for our research. • Specific consultation and troubleshooting on REDCAP or any improved similar data collection tools; it beats Qualtrics on most indicators but problematic still • The importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized. This is the Achilles Heel of many studies. • Training of graduate and post graduate young investigators in clinical translational research SC CTSI - Other valuable resources and services Asking the question, “What other services or resources would be valuable to your work?” elicited a dozen responses from faculty, including more than one expressed need for trained clinical coordinators. All faculty responses are shown below. Southern California Clinical and Translational Science Institute “The importance of having a participant recruitment service cannot be over emphasized. This is the Achilles Heel of many studies”
    • www.sc-ctsi.org | Page 14 Perceived Challenges in Conducting Clinical Research A qualitative review of the responses to the open-end- ed question, “What is your biggest challenge in con- ducting clinical research?” revealed a number of chal- lenges perceived by the community: Administrative hurdles (mentioned by 26% of faculty respondents), Funding (24%), Access to clinical data or specimens (21%), and Clinical research support staff (21%). Other frequent responses included Participant recruitment, Subject-specific expertise/assistance, and Dedicated time. The table below includes select responses as examples under each category; for a complete listing of responses, see Appendix E. Administrative Hurdles 22 26% 15 52% Funding 20 24% 4 14% Access to Clinical Data or Specimens 18 21% 4 14% Clinical Research Support Staff 18 21% 3 10% Participant Recruitment 15 18% 7 24% Participant Recruitment Needs Cohort recruitment and retention Recruiting and sustaining non english speaking populations Obtaining samples relevant to my studies Getting well characterized and well preserved specimen. Support Staff Needs Sufficient number of competent clinical research support staff Finding experienced research coordinators Specimen/Sample Access Compliance officers who don't understand human research Non integrated Administrative Systems The existence of so many different entities (CISO, CTSI, HRA, IRB, etc.) that have different requirements for similar things CRO Getting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely manner. Lack of Funding Getting NIH funding! Minimal start up funds available for junior faculty. Data Access Lack of databases to find patients with specific conditions / diagnoses Having to review paper medical charts, electronic charts, Affinity, Synapse systems to mine data Compliance Faculty (84 total respondents) Staff (29 total respondents) # of Unique Mentions # of Unique Mentions % of Respondents % of Respondents IRB/Regulatory Disorganized and disconnected systems for regulatory approvals. IRB delays Administrative Processing Time/Efficiency Cumbersome paperwork submission and review processes Con nued on p. 15
    • www.sc-ctsi.org | Page 15 Perceived Challenges in Conducting Clinical Research Subject Specific Expertise/Assistance 15 18% 4 14% Dedicated Time 12 14% 1 3% Communication, Support, and Engagement 6 7% Facilities and Space 5 6% 2 7% Working Collaboratively 3 4% 3 10% Not Categorized 4 5% 1 3% No institutional resources Positive outcome of the studies Team Building/Collaboration Identifying partners Differential capabilities and resources in interdisciplinary teams Keeping Confidentiality in diverse groups Facilities Lack of a CTU in a convenient location Getting quality microarray/Next Generation sequencing data done via a core Space People fight over freezer space Clinical Research Knowledge and Engagement Difficulties in enrolling patients into clinical trials (parental distrust of research) Disseminating information about the study to other treating physicians and patients in the community Departmental Support Obtaining fresh tumor specimens with Dept. cooperation and flexibility Securing time and money in the first place Coordinating dissemination of multiple secondary outcome papers after the funding for the clinical trial has ended and the primary outcomes have been published Mentorship Mentorship Funding Applications Assistance with applying for funding Help with protocol development and study design Lack of time Carving time away from my administrative demands Publication Biostatistics Access to clinicians with knowledge of biostatistics and time to help Data Management Data management Translational Value Evaluating how 'translatable' mouse research is to clinical issues Study Design Identifying the appropriate question to be addressed in a clinical study Faculty (84 total respondents) Staff (29 total respondents) # of Unique Mentions # of Unique Mentions % of Respondents % of Respondents
    • www.sc-ctsi.org | Page 16 Appendix A: Full Survey Survey Title New tools to enable clinical research: Clinical Data Warehouse for Research (CDWR) and Clinical Trials Management System (CTMS) Sec on 1 of 5: Par cipant Informa on 1. First & Last Name: [free text] 2. Title: [drop-down] Professor Associate Professor Assistant Professor Staff Other (please specify) [free text] 3. Highest Degree: [drop-down] MD PhD PharmD DDS DO MSW RN MBA DOT DPT MPH MS BS Other (please specify) [free text] 4. Email address: [free text] 5. Campus where you spend the majority of your me: [drop-down] University Park Campus Health Sciences Campus Children’s Hospital Los Angeles Both USC and Children’s Hospital Los Angeles Other (please specify) [free text] 6. School and Department/Division: [drop-down] Den stry Biokinesiology and Physical Therapy Biomedical Sciences Craniofacial Molecular Biology Dental Public Health and Pediatric Den stry Endodon cs, Oral and Maxillofacial Surgery and Orthodon cs Occupa onal Science and Occupa onal Therapy
    • www.sc-ctsi.org | Page 17 Periodontology, Diagnos c Services and Dental Hygiene Restora ve Sciences Other Engineering Biomedical Engineering Other Gerontology Medicine Anesthesiology Biochemistry and Molecular Biology Cell and Neurobiology Dermatology Emergency Medicine Family Medicine Medicine Molecular Microbiology and Immunology Neurological Surgery Neurology Obstetrics/Gynecology Ophthalmology Orthopaedic Surgery Otolaryngology – Head & Neck Surgery Pathology Pediatrics Physiology and Biophysics Preven ve Medicine Psychiatry and Behavioral Sciences Radia on Oncology Radiology Surgery Urology Other Pharmacy Clinical Pharmacy and Pharmaceu cal Economics and Policy Pharmacology and Pharmaceu cal Sciences Other Public Policy Social Work Other (please specify) [free text] 7. Are you affiliated with the USC Norris Comprehensive Cancer Center? [radio bu ons] Yes /No 8. What is your role and primary ac vity(ies)? Faculty Clinician researcher (>15% spent on research) Clinical research Clinical trials Human mechanis c research (including “-omics”) Cancer research Appendix A: Full Survey (cont’d.)
    • www.sc-ctsi.org | Page 18 Health outcomes/services Preven on research Behavioral research Epidemiology (including gene cs and epidemiology) Other (please specify) [free text] Clinician (0-15% spent on research) Transla onal researcher (early stage development) Drug development Devise development Other Basic researcher Staff Clinical research support Study coordinator Informa on science Program manager Finance Other research support (please specify) [free text] Other (please specify) [free text] Other (please specify) [free text] Sec on 2 of 5: Clinical Data Warehouse for Research (CDWR) The ques ons in this sec on pertain to the Clinical Data Warehouse for Research (CDWR). There is significant interest in the crea on of a clinical data warehouse for use by researchers across the USC enterprise. Containing pa ent data from USC hospitals, Children’s Hospital Los Angeles (CHLA), and ul mately Los Angeles County (LAC), the warehouse would support the research enterprise by enabling large-scale popula on analysis and aggregate data output, as well as cohort iden fica on and other efforts. 9. For what purpose(s) would you use a clinical data warehouse? Please rate each of the following in terms of its importance to your research. [radio bu ons] 0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Iden fica on of poten al par cipants in on-going or planned clinical trial Historical data extrac on for retrospec ve studies Health outcomes research Health access dispari es research Precision/personalized medicine Health effec veness research Health economics/cost effec veness research Quality healthcare research Other (please specify) [free text] 10. Listed below are types of data that could be included in a CDWR. Please rate each of the following in terms of its importance to your research. [matrix] 0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Appendix A: Full Survey (cont’d.)
    • www.sc-ctsi.org | Page 19 Demographics Diagnoses (ICD 9/10) Procedures (CPT) Medica ons Laboratory test results Radiology reports Stage (for cancer diagnoses) Pathology reports Outcomes Financial/cost data Insurance coverage Bio-repository data Gene c/genomic data Elements of physical exam – vital signs Elements of physical exam – other than vital signs Review of Systems (i.e., a checklist covering the organ systems) Allergies Smoking status Drug/Alcohol use Family history Images Physician notes Other text in medical records Other data type (please specify) [free text] 11. In addi on to hospital electronic medical records, pharmacy records, lab data, and financial systems, are there other sources of data that you would like to see ul mately included in the CDWR? (Check all that apply) [check box] Cancer Registry Cardio Registry Death Registry(ies) Other (please specify) [free text] 12. Please rate the importance to your research of having access to clinical data from the following loca ons. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Keck Medical Center of USC Children’s Hospital Los Angeles LA County Hospital (LAC+USC) LA County public health system (DHS) 13. Please rate the importance to your research of having a structured biorepository. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al 14. Please provide any other feedback/concerns you may have related to the CDWR. [free text] Appendix A: Full Survey (cont’d.)
    • www.sc-ctsi.org | Page 20 Sec on 3 of 5: Clinical Trials Management System (CTMS) The following ques ons pertain to the development of a Clinical Trials Management System (CTMS). 15. Please rate each of the following capabili es of a CTMS in terms of its importance to your research. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Study Management (protocol tracking; enrollment tracking; study calendar) Financial Management (study budge ng; Medicare coverage analysis; invoicing) Pa ent Management (pa ent enrollment, iden fica on, and randomiza on; scheduling; eligibility tracking; adverse event tracking) Report and Data Management (electronic case reports; data repor ng and export tools) Biorepository Management (specimen and result tracking; inventory management) Impor ng current clinical study data from my exis ng database(s) Other (please specify) [free text] 16. Please provide any other feedback/concerns you may have related to the development and implementa on of a CTMS. [free text] Sec on 4 of 5: Addi onal par cipa on in planning process 17. We will soon begin selec ng individuals to guide the development of the CDWR. We want broad representa on of perspec ves and research areas. Would you be interested in par cipa ng in: (check all that apply) [check box] a. Quarterly mee ngs intended to update and gather input from a broad range of users on the development and implementa on of the CDWR? b. A working group that met more frequently (e.g., monthly) to develop key func onality, policies or opera onal strategies for the CDWR? 18. We will soon begin selec ng individuals to guide the development of the CTMS. We want broad representa on of perspec ves and research areas (faculty and staff). Would you be interested in: (check all that apply) [check box] a. A ending two CTMS vendor demonstra ons and rate their func onality, ease of use, etc., on the a ernoons of May 13th and May 29th on the HSC campus? b. Par cipa ng on an advisory commi ee regarding development/implementa on and policy development for a CTMS (mee ng every 6 to 8 weeks or via email ques ons)? c. Serving on a working group that meets more frequently (e.g., monthly) to develop opera onal strategies for the CTMS? Sec on 5 of 5: Exis ng and poten al clinical and transla onal research infrastructure The Southern California Clinical and Transla onal Science Ins tute (SC CTSI) is focused on serving researchers and would like to be er understand your current needs. 19. Please rate the following currently available resources/services, in terms of importance to your research. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Appendix A: Full Survey (cont’d.)
    • www.sc-ctsi.org | Page 21 Pilot Funding: to support research, career development, innova ve technologies and methodologies, progression of discoveries and mul disciplinary team forma on Clinical Research Space and Services: two clinical sites; outpa ent and inpa ent clinical research space; access to trained clinical research staff; sample procurement; specimen processing and handling laboratory; neurologic and bionutri on evalua ons; and more Consulta on Services: Research advice from faculty, senior staff and external consultants Study Design Regulatory Knowledge and Support Research Ethics Conduc ng and Managing Human Studies Data Management Bioinforma cs Biosta s cs Sta s cal Analysis Scien fic Wri ng Transla on of preclinical discoveries Community-engaged Research 20. Please rate the following under considera on resources/services. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al Par cipant Recruitment Service: Exper se, tools and resources to recruit par cipants for studies Clinical Research Coordinator Core: Trained coordinators available on an ad hoc recharge basis 21. What other services or resources would be valuable to your work? [free text] 22. What is your biggest challenge(s) in conduc ng clinical research? [free text] Appendix A: Full Survey (cont’d.)
    • www.sc-ctsi.org | Page 22 Appendix B: CDWR – Other Types of Data Faculty responses to “Other data type [that could be included in a CDWR]”: • adverse events, provider type (dept, service), guideline use • behavioral health history • Digital static, dynamic, and video Histopathology and cytopathology whole slide images • Emergency department visits, Hospitalizations • followup • For personalized “omics” and tranlational studies the quality of specimens collected and saved,clincal stages of the disease and response to thearapy data are critical. • If waveforms for vital signs and hemodynamic variables were available • Interventions (intubation, inotropes, CPR, etc.) • language • Medical errors, Medical malpractice claims that resulted • Medical images, surgical history • medical service use, unit in hospital, advance directive status and content, palliative care consultation • outside referral records • Plasma and CSF samples • pregnancy and birth data • prescribed and implanted medical devices • prescriptions; evidence of adherence; recommendations for devices; use of technology; role groups en- gaged with patient; number of contacts for specified clinical problems; note this list is written for MDs, we need all disciplines including patients engaged in building such a data warehouse • Primary care physician • Rehabilitation utilization and daily documentation • reproductive history • samples and data of healthy potential matched controls • signs and symptoms • socioeconomic status; marital status; a brief clinical survey about health behaviors (e.g., physical ac- tivities); residential addresses • surgical reports, biorepository of cultured organisms • The kind of data that would be relevant for many rehabilitation trials is not reflected above. This data- base seems as if it would largely serve the needs of those interested in pharmacological issues. • tumor biology features (estrogen receptor, progesterone receptor, HER2) • what treatment they received and for how long
    • www.sc-ctsi.org | Page 23 Appendix C: CDWR – Other Feedback and Concerns Faculty responses to “Please provide any other feedback/concerns you may have related to the development and implementation of a CDWR”: • Would be hugely helpful but as a Division Chief for many of my faculty, essential to advancing us as an academic medical center. • Data must be stored in an abstract able/searchable format 2. Must be integrated to clinical work-load so as to prevent duplication 3. Who owns the data? • Adequate support for the infrastructure is critical. In my experience, it cannot be dependent on indi- vidual investigator’s grant support/chargebacks. This is a capital investement in our future as a research institution. • As near real time as possible • Need a transdisciplinary focus, engage patients and all providers in building key elements; recall for pharmacy: too often data bases track what was dispensed or prescribed and no data on patient use of drugs including nursing notes and data on prescription refills • Biorepository needs to be clinically annotated. Infrastructure needs to be established for tumor bank- ing and adequate communication with operating surgeons/research coordinators and pathology. The department of pathology and department of surgery members who participate in tumor banking should receive credit as co-authors on manuscripts resulting from their efforts. • Biorepository should if possible have bloods at various stages of disease for biomarker discovery. • Development of a useful and accessible database is critical to my research. Difficulty in getting this information has the primary roadblock in getting research completed. • I know from experience that absorbing free text could pose HIPAA issues - it is more difficult to mask. If we had an identifier that lets us track back to MR where necessary, that might help. • I would be happy to help develop data structure for assessment of family structure and history, and history of exposure to selected agents • Key is connecting the LAC+USC patient data & the UH/Norris patient data. • Please see earlier note. While I’m sure this database will mee the needs of those interested in pharma- cological and medical interventions, it will may not fully support rehabilitation efforts as currently designed. • something that is critically needed, however there are other registries for a variety of specialties, so one challenge is to integrate the data capture for this database with already exisiting databases. • We are particularly interested in the sustainability of changes obtained during hospitalization and as such are interested in follow-up status data. • Working on clinical samples has been abasic problem because “birepositories” are personal! No shar- ing unless there is a personal interest. • would be excellent to link this directly to the EMR and make the EMRs able to communicate across campuses.
    • www.sc-ctsi.org | Page 24 Appendix C: CDWR – Other Feedback and Concerns (cont’d) • Would be great to have a clinical data warehouse that is linked anonymously to biorepository of pa- tient specimens • Would suggest periodic update of the patient information so patient information can be followed lon- gitudinally
    • www.sc-ctsi.org | Page 25 Appendix D: CTMS – Other Feedback and Concerns Responses to “Please provide any other feedback/concerns you may have related to the development and implementation of a CTMS”: Faculty • Cafe and Redcap are working well • Need to have it operative at County as well as USC. Also, would be great if it alerted when protocol patient showed up for a regular health system visit. • Please arrange focus groups and other feedback opportunities after this survey is completed • Would like integration of the biorepository clinical data to be linked to clinical trial data so outcomes can be analyzed based on genomic and other biomarkers • Would love for this to ultimately communicate with other data repositories and large databases. The ability to import data from large databases into this would be phenomenal. • Would need to be able to access from my LAC office computer; archives from paper medical records Staff and Other • Better still is if the electronic case reports, data reports can self-populate from the hospital systems • Concern if the study specific trial has it specific tracking logs then having to enter the same informa- tion into the CTMS system? Or would the CTMS be used if the trial did not have these systems are in place. • Development of the management systems is theoretically a good idea, however, general systems are often not setup to individual project needs • Having a fair, easy to use system to access clinical samples (i.e., one PI can’t keep all the samples!) • It will hopefully be more intuitive and user-friendly than TRUE 2.0. • The system should ideally accommodate, be useful to, various types of research and disciplines
    • www.sc-ctsi.org | Page 26 Appendix E: All Perceived Challenges All responses to “What is your biggest challenge(s) in conducting clinical research?” by category: Access to Clinical Data or Specimens Data Access Absence of centralized resources, data and procedures, making start-up extremely taxing Access to affordable blood draws and tissues biopsies in human research access to data Access to Electronic Medical Records data for CTMS Having to review paper medical charts, eletronic charts, Affinity, Synapse systems to mine data Lack of access to patient clinical data and difficulty in identifying eligible patients for retrospective radiology studies Lack of data collection Lack of databases to find patients with specific conditions / diagnoses lack of infrastructure to access large patient dataset and biospecimens linking biospecimens to clinical data No central database no source of clinical data the lack of a searchable medical records for study recruitment We need a database and the associated support to extract information from the existing patients population to form and test hypothesis, and to develop prospective clinical studies Specimen/Sample Access Collection of specimens Getting well characterized and well preserved specimen. We need a”CORE” for preserving quality contrrolled specimens that can be used for many different tests in the future. The core should save not only the specimen slides or paraffin blocks but also RNA, DNA and protein if material is available for future omics studies.If fresh material is available then tissue should be cultured for short term and preservrd in small aliquots for research having access to tissue lack of infrastructure to access large patient dataset and biospecimens Lack of resources available (no system for creating a tissue repository)-every lab does it differently Obtaining fresh tumor specimens with Dept. Pathology cooperation and flexibility obtaining samples relevant to my studies The Tissue Procurement Core as it is currently being run is my biggest challenge. Administrative Hurdles Administrative Processing Time/Efficiency Cerner cumbersome paperwork submission and review processes Efficient start-up including development of the CRFs, database, and recruitment infrastructure Paperwork
    • www.sc-ctsi.org | Page 27 the most challenging issue is the bureaucracy that county has. the lab agreement takes a long too long to approve, then after that to pull the slides and blocks more and more time. very inefficient, they lead you to despair. I hope there is another way to cut the time and rush things through the USC bureaucracy and paperwork, the process needs to be streamlined, and much mor efficient if we are going to compete for clinical research grants with other established institutions TIME- Gathering so much info to put a patient on study or waiting for data that you need to enter from and off site slows down the process and you now have others waiting on you for what your waiting on Too much administrative paperwork and requirements to be met - EVERYBODY has more and more from C and G to financial systems, to Research Admin! working with grants and contracts: now that the system will be changing and will the new staff be able to decrease the turn around time of executing contracts and assisting with working witht the research team to build and provide a budget Compliance Compliance is not helpful with executing contracts or confidentiality agreements. Compliance compliance officers who don’t understand human research CRO Also approval from CRO (approx 3-6 months) for a research order form is too long and hinders research. We’ve had student research delayed because they did not receive necessary approval from CRO, despite frequent follow-up. For Industry Sponsored clinical trials, the amount of time it takes to negotiate and finalize an agreement has discourage my faculty from working with industry sponsors Getting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely manner. Getting the MCA, budget & Research Order Form for non-industry sponsored trials lack of infrastructure for performing clinical trials Timely sponsor contract negotiation and approval, MCA, and budget negotiation and approval Unhelpful and procrastinating CRO; ineffective, slow contract negotiation IRB/Regulatory Getting anything through the IRB process. It takes FOREVER! getting studies approved by IRB Having a structured system and adequate personnel in ensuring that the regulatory group is able to do their tasks accurately and in a timely manner Initial regulatory hurdles before a study is opened IRB delays and inflexibility Obtaining regulatory approval Regulatory environment then all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which reserachers and thier teams can access all aspects of tools and retulatory applications for clinical research working through the IRB process writing IRB Non-integrated Administrative Systems A website with guidance (contact info, necessary forms, etc) would be helpful. Appendix E: All Perceived Challenges (cont’d.)
    • www.sc-ctsi.org | Page 28 Coordinating efforts/reports/applications across disciplines and school the bureaucratic nightmare that is USC. As a coordinator there are over a dozen different USC departments that I need to go through in order to set up new studies and have proper training/clearance/access to information. This is especially true with regards to budgeting and contracting The existence of so many different entities (CISO, CTSI, HRA, IRB, etc.) that have different requirements for similar things--for example, I had to take 2 HIPAA courses that were almost identical when I first started working here. The office of compliance didn’t recognize the one that was on the IRB website. The roles (of all of the different departments) get confusing. The very limited central infrastructure at USC for research. Unfortunately, what little infrastructure that is available in our system is set up for departmental research and not programmatic research then all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which reserachers and thier teams can access all aspects of tools and retulatory applications for clinical research too many systems Working within different departments to coordinate scheduling of patient procedures Clinical Research Support Staff A clinical research coordinator core would be exxtremely helpful for a biological / biomarker study we are trying to get off the ground. Our clinical trials office has indicated they are too busy to obtain consents and accrue samples, but at the same time it would not be appropriate for lab researchers to obtain consents and samples. A core - which could charge for their expertise in coordinating such activities - woudl be a great help Absence of centralized resources, data and procedures, making start-up extremely taxing Access to resources to perform the research administer pharmacological manipulations As Research Administrator, assisting faculty with determining who the appropriate contacts are to have blood work or radiology work done available research assistants coordinating all study personnel, as a Ph. D. researcher this is challenging Coordinating efforts/reports/applications across disciplines and school Finding experienced research coordinators lack of mid-level support so that faculty can concentrate on academic endeavors lack of support staff Not having enough regulatory staff to do the work Overworked research coordinators person to mine the data project managers qualified staff to conduct specific tests within in budget limits, (e.g. treadmill, dexa) management and analysis of blood assays scheduling CTU visits skilled research assistants Study coordinator or research nurse sufficient number of competent clinical research support staff Support staff Appendix E: All Perceived Challenges (cont’d.)
    • www.sc-ctsi.org | Page 29 Communication, Support, and Engagement Clinical Research Knowledge and Engagement difficulties in enrolling patients into clinical trials (parental distrust of research), Disseminating information about the study to other treating physicians and patients in the community getting MDs to comprehend clinical studies and getting their approval for pt participation lack of knowledge on the part of departments when they want to be supportive Departmental Support lack of department support Obtaining fresh tumor specimens with Dept. Pathology cooperation and flexibility Dedicated Time Carving time away from my administrative demands finding adequate time given clinical care obligations Having dedicated research time away from my clinical duties protected time Securing time and funding in the first place time time time away from clinical responsibilities Time from clinical responsibilities Time! Trite but true: time and money Facilities/Space Facilities adequate user and patient friendly facilities lack of a CTU in a convenient location we need more clinical research facilities Sample Processing Core Getting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician. Space laboratory space people fight over freezer space space Funding $$$ Access to affordable blood draws and tissues biopsies in human research adequate funding Assistance with applying for funding Funding Appendix E: All Perceived Challenges (cont’d.)
    • www.sc-ctsi.org | Page 30 funding, decrease NIH funding Funding. Much of the funding available through major funding agencies is less likely to be directed towards rehabilitation clinical trials funds Getting NIH funding! inexperience with defining and framing clinical research questions and how to get pilot funding to pursue Lack of sufficient funding from federally supported trials minimal start up funds available for junior faculty. Obtaining funding securing funding Securing time and funding in the first place Trite but true: time and money Not Categorized I currently perform basic with translational outlook research only Lack of infrastructure support No institutional resources Positive out come of the study’s REDCAP type tools Participant Recruitment Acquiring subjects Cohort recruitment and retention Efficient start-up including development of the CRFs, database, and recruitment infrastructure Follow-up attrition Having access to patients to get clinical samples inform consent knowing how to recruit and consent patients Lack of resources to streamline pre-screening for subjects participant recruitment Patient accrual Patient Recruitment patients recruiting and sustaining non-english speaking populations recruiting subjects recruitment Recruitment and retention recruitment and retention of study participants Recruitment of Patients The cancer registry has numerous wrong numbers and unable to locate patients using other resources Appendix E: All Perceived Challenges (cont’d.)
    • www.sc-ctsi.org | Page 31 The importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized. This is the Achilles Heel of many studies understaffing for participant recruitment and follow-up Subject-Specific Expertise/Assistance Biostatistics access to clinicians with knowledge of biostatistics and time to help analysis As a new researcher, help with protocol development and study design; statistics Getting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician. management and analysis of blood assays - currently using Quest and would like to keep it in-house if cost effective statistical support Data Management data management Data Management We need a database and the associated support to extract information from the existing patients population to form and test hypothesis, and to develop prospective clinical studies Funding Applications Assistance with applying for funding Initiating Studies Identifying the appropriate question to be addressed in a clinical study inexperience with defining and framing clinical research questions and how to get pilot funding to pursue Mentorship mentorship Protocol Development As a new researcher, help with protocol development and study design; statistics Publication Coordinating dissemination of multiple secondary outcome papers after the funding for the clinical trial has ended and the primary outcomes have been published Study Design As a new researcher, help with protocol development and study design; statistics Translational Value Evaluating how ‘translatable’ mouse research is to clinical issues Knowing how to move from a basic discovery to translational study Working Collaboratively Matching Service In my particular case I am in a situation where as an Biomedical Engineer I need to work in conjunction with a clinician. It would be helpful to have a matching service, where technical experts can work with clinical experts to work on issues and projects. Appendix E: All Perceived Challenges (cont’d.)
    • www.sc-ctsi.org | Page 32 Differential capabilities and resources in interdisciplinary teams. Example: citation software saves valuable time, can we get equal access to EndNote and RefWorks and easy transfer of files? Referencing should not be a burden in building a grant application given these resources. Make sure that all researchers know of new ORGANIZATION option on Blackboard for posting materials, sharing announcements, drafts etc. Experts should explore and coach on use of Discussion board to short circuit asynchronous emails. facilitating collaboration forming a multidisciplinary team Identifying partners My area of research is based on addiction. We do not have a strong addiction clinical group at USC. Currently collaborating with UCLA Keeping Confidentiality in diverse groups Appendix E: All Perceived Challenges (cont’d.)