#1PUERTO RICO HEALTH PRIDC ARE COUNCIL Colegio de PUERTO Médicos CIRUJANOS de 19 95 Rico Clinical research interest, experience, strengths, and difficulties of physicians in Puerto Rico survey For INDUNIV's Puerto Rico Health Care Council and Colegio de Médicos Cirujanos de Puerto Rico#2INDUNIV's Puerto Rico Health Care Council Dr. Carlos Tollinche - Director of Scientific Affairs and LiSci Clusters Education Liaison ■ Mr. Iván Lugo - Executive Director INSPIRA Clinical Research - Bayamón; University of Puerto Rico - Medical Sciences Campus Dr. Wilfredo E. De Jesús-Monge ■ Dr. Iván Figueroa-Agrinsoni Abbvie Efraín Piñero and Paola C. Rodríguez-Adorno University of Puerto Rico – Río Piedras Campus Members and guests who provided feedback while attending the monthly meetings RICO PUERTO R HEALTH RIDCO CARE COUNCIL MINDAN Dec#3Colegio de Médicos Cirujanos de Puerto Rico Clinical Research and Technological Development Institute Dr. Carlos Díaz-Vélez – President and Representative to INDUNIV's PR Health Care Council ■ Ms. Vilma I. Sáez-Vélez - Executive Secretary and Coordinator - Dr. Wilfredo E. De Jesús-Monge – San Juan Medical District Representative and Advisor Colegio de Médicos CIRUJANOS 19 95 PUERTO Rico DT INSTITUTO DE INVESTIGACIÓN CLÍNICA Y DESARROLLO TECNOLÓGICO#4Introduction#5Clinical Research in Puerto Rico Clinical research quality in PR is at the level of key US states and has clinical research expertise in global research focused disease areas (pwc, 2015) However, clinical trial activity is declining in PR, both in terms of patient enrollment and clinical trial numbers; PR is not perceived as having superior clinical research and expertise; and lacks a strong research culture (pwc, 2015) Therefore, there are few reasons for physicians to become principal investigators and to train staff (pwc, 2015) A qualified physician, who is an investigator or a sub-investigator, for the trial, should be responsible for all trial-related medical decisions (ICH-GCP, №996)#6INDUNIV Industry University Research Center Nonprofit organization representing industry, government and the academic sector ■ Puerto Rico Health Care Council ■ Focused on promoting initiatives that will improve the life of our people and promote the development of new business in the field INDUNIV INDUSTRY UNIVERSITY RESEARCH CENTER, INC. PUERTO RICO HEALTH PRIDCO CARE COUNCIL#7Colegio de Médicos Cirujanos de Puerto Rico Organization that groups all licensed physicians in Puerto Rico ➡ Clinical Research and Technological Development Institute Promotes, foster, and facilitates clinical studies and scientific research that contribute to the advancement of medicine and the public health of Puerto Rico Colegio de Médicos CirujaNOS 19 95 PUERTO Rico 16 DT INSTITUTO DE INVESTIGACIÓN CLÍNICA Y DESARROLLO TECNOLÓGICO#8The survey The purpose of this survey is to know the profile of clinical investigators, where are they located, their strenghts and the difficulties they face ■ In addition, a registry of clinical investigators in PR will be made, to which respondents can voluntarily sign up The registry may be used to directly provide clinical studies opportunities in PR to the registrants The participation is voluntary and the information will be kept confidential There are approximately 10,000 licensed physicians in PR, all members of the Colegio de Médicos Cirujanos de Puerto Rico#9Methods ■ The survey was designed, reviewed, and tested as a group with members and guests of INDUNIV's Puerto Rico Health Care Council monthly meetings. ■ The survey was placed in the SurveyMonkey platform and sent to the members of the Colegio de Médicos Cirujanos de Puerto Rico via e-mail blast for a few months ■ The survey was closed and results were collected and analyzed#10Results#11Do you currently conduct clinical research in your medical practice? (all that apply) all respondents = n = 296 Clinical research ■ Research with human subjects that is: Patient-oriented research (or on material of human origin such as tissues, specimens, and cognitive phenomena) that can be linked to a living individual Epidemiological and behavioral studies ■ Outcomes research and health services research 28.7% Yes 20.9% 8.4% I did in the I did in the past and I am past and I am interested now not interested now 27.4% I have never done it, but I am interested now 15.5% I have never done it and I am not interested now#1248% Physicians who currently conduct clinical research in PR 3% Gender 49% ■Male ■Female Prefers not to answer Age (years) 1% 5% 5% 21% 8% 120-30 ■31-40 ■41-50 ■51-60 ■61-70 17% ■71+ Prefers not to answer 43%#1345% Physicians who currently conduct clinical research in PR Which type of clinical practice you currently conduct? (all that apply) 54% 24% 24% 6% In which medical specialty would your clinical research would be classified? (all that apply) ➡ Top 5 Subspecialties: 47% ■ Internal Medicine: 19% ■ Pediatrics: 16% ■ Psychiatry/Neurology: 13% General Medicine and Obstetrics/ Gynecology: 10% Individual Group Academic Exclusively associated with clinics and/or Do not practice hospitals#14Physicians who currently conduct clinical research in PR If you are a specialist: are you board certified? For how many years have you conducted clinical research? 28% 9% 63% Yes No Not specialist 19% 28% 9% 16% 28% ■1-5 years 16-10 years 11-15 years 16-20 years 21 or more years#15Have staff 57% Physicians who currently conduct clinical research in PR Clinical research coordination staff, facilities, and setting (all that apply) 40% 33% 28% 20% No staff Have facilities No facilities Independent Collaborates with other professionals Sponsors (all that apply) 54% 55% 81% Companies (industry) in USA Companies (industry) outside USA 35% 17% 13% 13% 7% 5% NIH and other federal agencies Contract Research Organizations Academia Foundations Cooperative groups Other#1629% 57% Physicians who currently conduct clinical research in PR Which type of clinical research do you currently conduct? (all that apply) To which health and disease aplication may your clinical research be classified? (all that apply) 81% ■Mechanism of disease ■Clinical trials 31% 42% 25% ■Phase 1 37% Phase 2 19% 18% Phase 3 Phase 4 14% 7% 11% ■Medical devices Epidemiology Behavioral Health Services Other 25% 27% Prevention (including vaccines) Early detection ■Diagnostics ■Treatment 42% 29% Quality of life Other 8%#1733% 23% Physicians who currently conduct clinical research in PR In which therapeutic area may your clinical research be classified? (all that apply) 37% ■Infectious ■Cardiovascular Cancer Substance addiction ■Pulmonary ■Digestive 18% Hematology 17% 16% Endocrine 13% ■Renal 25% ■Pain management ■Reumathology Trauma 11% 5% 4% 8% 8% 1% In which professional stage have you conducted clinical research? (all that apply) 58% 47% 46% 25% 16% 11% 5% 80% High school Undergraduate ■Post-bach (no degree) Graduate ■Medical school Residency Research resident or fellow Fellowship ■Practice Other 7% Other#1848% Physicians who currently conduct clinical research in PR Which represents your clinical research 81% education and training? (all that apply) What motivates you to conduct clinical ■National Institutes of Health 89% Mentorship 59% IRB-required 49% 46% Training program 52% 49% 41% Sponsor training 29% ■Self taught 27% ■Continued medical education 5% Other research? (all that apply) Variety in daily medical practice Personal, family, or emotional experience with disease Producing or contributing to new knowledge ■Professional recognition 20% CME credits 5% 2% Financial income#19Physicians who currently conduct clinical research in PR Which statement best describes your circumstance for each of the following items related with the conduct of clinical research: "I have it and it strengthens me" or "I do not have it and, therefore, gives me difficulty"? 87% Knowledge about the process and topics of clinical research 8% 89% Experience Good English language communication skills Available time or its effective organization Effective communication with sponsors 6% 95% 1% 73% 20% 73% 19% 64% Available resources in my office or institution 31% Institutional support Federal government funding 70% 19% 28% 7% PR government funding Other доодоо 18% 51% 63% "I have it and it strengthens me"#20Aguadilla Mayagüez Hormigueros San Cabo Rojo Germán Lajas Las Marías Sabana Grande Municipalities where clinical research is conducted Arecibo Yauco Ponce Ciales Barceloneta Manatí Jayuya Loíza Salinas Orocovis Barranquitas Corozal Comerio Cayey Guayama Vega Alta Bayamón Aguas uenas Guanabo Caguas San Juan Carolina Trujillo Alto Gurabo Canovanas Fajardo#21Do you want to learn about initiatives, events, courses, and/or lectures related with clinical studies topics? -2% Physicians who currently conduct clinical research in all respondents = n = 296 PR 98% Sí No ■ Si 84.5 % ■ No 15.5 %#22Summary of results and discussion The response rate was very low, approximately 3% Among the respondents, approximately, 3 out of 10 physicians currently conduct clinical research in his/her medical practice ■ Physicians who currently conduct clinical research in PR: Genders are evenly distributed and the largest age groups are 51-60 and 31-40 years old Most of them practice in an academic setting The top medical specialties in which clinical research may be classified are Internal Medicine and Pediatrics ■The majority are board certified specialists#23Summary of results and discussion Physicians who currently conduct clinical research in PR: The largest groups conduct clinical research for 6-10 and more than 21 years The majority collaborates with other professionals and have clinical research coordination staff; are sponsored by industry in the USA and academia; conduct clinical trials, mainly Phase 3, treatment trials; and are educated / trained through IRB certifications and mentorship The largest group conduct Infectious diseases research A trend of clinical research experience through professional stages can be seen since undergraduate#24Summary of results and discussion Physicians who currently conduct clinical research in PR: The majority are motivated by the production or contribution to new knowledge and variety in medical practice Good English language communication skills is the most common attribute that strengthens and lack of PR government funding is the most common attribute that causes difficulty Almost all of physicians who currently conduct clinical research in PR and most of the respondents overall want to learn about initiatives, events, courses, and/or lectures related with clinical studies topics#25Limitations ➡ Low response rate, with known physician researchers not been voluntarily registered ■ Recall bias ■ Some of the questions may have been confusing#26Future work Fix the questions as needed and repeat trying to gather a larger sample Design a more specific survey, based on focus groups, for Internal Medicine and Pediatrics physician reseachers#27Conclusion ■This survey is a good starting point to know the profile of clinical investigators, where are they located, their strenghts and the difficulties they face In addition, the produced registry of clinical investigators in PR is the beginning to which more physician researchers can be added Physicians in PR want to learn about initiatives, events, courses, and/or lectures related with clinical studies topics#28PUERTO RICO HEALTH PRIDCO CARE RE COUNCIL MINDAN PUERTO Médicos Cirujanos de 19 95 Colegio de Rico Acknowledgments Members and guests who provided feedback and valuable discussion during the INDUNIV's Puerto Rico Health Care Council monthly meetings