Certification of Physicians and Non- Physicians in the United States

Transcription

1 Certification of Physicians and Non- Physicians in the United States Academy of Pharmaceutical Physicians and Investigators Affiliated with Association of Clinical Research Professionals Chris Allen, MD, FRCA 1

2 Presentation Overview of APPI and ACRP ( background for Certification activities) Certification and its Importance 2

3 Mission of APPI To enhance the proficiency of pharmaceutical physicians and physician investigators, the Academy shall promote the acquisition and dissemination of knowledge concerning the therapeutic action, investigation and development of medicines, devices and diagnostics, and the protection of the welfare of patients and study subjects 3

4 Mission of ACRP To provide global leadership for the clinical research profession by promoting and advancing the highest ethical standards and practices. 4

5 History of APPI 1989 American Academy of Pharmaceutical Physicians (AAPP) Created by Medical Relations Committee of the Medical Section Steering Committee of US Pharmaceutical Manufacturers Association (PMA) 1993 AAPP Incorporated 1993 AAPP Joined IFAPP 2003 AAPP Set standards for certification 2004 AAPP Launched CPI exam process 2005 AAPP Reincorporated as APPI 2005 APPI Merged with ACRP 5

6 History of APPI Initially limited to physicians working for PMA member companies Expanded to physicians in non-pma pharmaceutical companies, biotech industry and related organizations (FDA, CROs, Academia, PIs, Consultants) Physician investigators became most rapidly growing constituency Focus is on pharmaceutical medicine practice, drug, device and diagnostic development and professional certification Set standards and monitor ethics in clinical research 6

7 History of ACRP Organization 30 years old Includes all members of the Clinical Research team Significant growth in membership to 22,000 clinical research professionals Provides Home for all pharmaceutical medicine professionals Focus on Education and Certification of the entire Clinical Research Team Members work in academia, government, industry or run small businesses 7

8 Affiliation Advantages Both organizations more visible and able to further missions more effectively APPI adds strong physician presence and expertise ACRP brings all members of clinical research team together and provides professional support services, Washington presence and educational facilities Combined meeting unique APPI program at front end of Global Conference in North America; ACRP also holds European and Regional meetings Together, much better chance to impact public policy and standards, processes and ethics of clinical research 8

9 Structure Association of Clinical Research Professionals 20,000+ Members 70% members with over 6 years experience in Clinical Research Academy of Pharmaceutical Physicians and Investigators -1,276 Pharmaceutical Physicians (formerly AAPP) & Physician Investigators -Administrative entity of Physician Investigator certification programs Academy of Clinical Research Professionals -Administrative entity of CRA, CRC, and CTI (non-physician investigator) certification programs and governmental affairs activities -10,600+ members holding active certification 9

10 What is Certification? Certification Formal recognition that a clinical research professional has met a recognized standard of jobrelated competency (knowledge, skills and behavior). A A hallmark of of true true professionalism is is rigorous training training and and certification, through through a formal formal examination process, process, that that individuals have have mastered the the knowledge and and skills skills required according to tostandards established by by their their peers. peers. ACRP ACRP and and APPI APPI have have built builteffective, rigorous certification processes for for the the entire entire clinical clinical research team. team. Everyone engaged in in the the practice practiceof of clinical clinical research should should acquire acquire certification as as a personal demonstration of of our our commitment to to the the highest highest standards of of professional conduct. --Greg Greg Koski, Koski, PhD, PhD, MD, MD, CPI, CPI, former former Director of of OHRP OHRP 10

11 APPI and ACRP Certification Organizations offering validated exams specific to function and region Questions written by professionals with extensive experience in field Exam questions updated every cycle Exams address content gleaned from periodic and extensive job analysis survey to ensure relevance and timeliness Validation by certified testing agency ACRP - more than 6,000 CRAs and 11,700 CRCs certified since

12 Certification Status and Future APPI is now the only general professional medical organization in US offering physician investigator certification (AAPP, ACRP & DIA exams consolidated under APPI) 2001 First investigator exam - more than 500 physicians now certified APPI exam also offered internationally in a European and ICH format Rationale: To raise the standards, processes, ethics and image of Clinical Research/Clinical Trials 12

13 Certification Eligibility Certified Physician Investigator (CPI ) Exam Level of Education and Training MD degree (or equivalent); postdoctoral training Current license to practice medicine required Training in GCP principles, regulations, ethics Specific courses not prescribed Relevant Experience Minimum 2 years experience as primary, sub, or co- investigator OR medical monitor, supervisor, or designer of clinical trials OR completion of an accredited clinical research degree or clinical research fellowship 13

14 Certification Eligibility CRA / CRC Exam Level of Education Degree level or equivalent Relevant Experience: minimum of 2 years exposure to the broad range of tasks performed CRA Requirements: University degree or paramedical qualification (e.g. nurses): 2 years full-time or 4 years part-time clinical research experience Associates degree: 3 years full-time or 6 years part-time clinical research experience No university degree or paramedical qualification: 4 years fulltime or 8 years part-time clinical research experience 14

15 Content Outline Certified Physician Investigator Exam 125 Multiple-Choice Questions 1. Study Management (12 questions) - Protocol Evaluation - Site Preparation and Initiation 2. Project Activities (50 questions) - Investigational Product Accountability - Laboratory and Diagnostic Issues - Adverse Events - Closeout - Responsibilities and Obligations 15

16 Content Outline - Cont. 3. Subject Management (50 questions) - Recruitment - Informed Consent - Scheduling/Screening - Study Conduct 4. Documentation and Administration (13 questions) - Case Report Forms - Source Documentation - Financial/Budgetary Issues 16

17 Certification Methodology Types of Exam Questions: Recall Application Analysis Rationale for Methodology: Multiple-choice allows greater representation of the full spectrum of the syllabus 4 options per question No true/false questions Usage of universally recognized/accepted terminology (reduction of subjectivity and prejudice to non-english speakers) Reliability 17

18 Certification Methodology Question Creation Job Analysis Survey conducted every 2-3 years to supply substantial evidence of content validity and job relatedness Questions are drafted by professionals with significant relevant expertise Questions are systematically tested prior to inclusion APPI Physician Certification Committee operates under strict policies and procedures to maintain high standards and autonomy 18 18

19 Certification Methodology Exam Scoring Independent testing agency used since 1992 Questions receiving higher than expected wrong answers or comments are reviewed by examination committee Exam Results Pass rate approximately 75% Communicated by AMP via mail within 6 weeks of exam Results, questionable items and comments of takers reviewed after each test 19

20 Certification Maintenance Required every 2 years to maintain certified status: Objective is to demonstrate continued involvement and competence Eligibility requires acquisition of at least 24 points to demonstrate continued involvement and education (Examples of eligible activities - not all-inclusive) CME in relevant areas Authorship of research protocol Serve as director of research center Serve on CPI exam committee Authorship of clinical study report (s) Peer- reviewed scientific manuscripts Author of clinical research paper 20

21 Certification - Benefits Recognition by global clinical research community Set standards of professional practice Professional satisfaction Pharmaceutical companies, regulators and CROs starting to encourage certification Aimed at improving study subject protection Certification says says a lot. lot. You You are are not not only only serious about your your job, job, but but that that you ve gone to to the the extra effort to to learn what is is required. Those of of us us who who have taken the the exam passing is is not nota given take take a lot lot of of pride in in having done it. it. --Certified Certified Clinical Clinical Research Research Coordinator Coordinator (CCRA) (CCRA) 21

22 Certification Public Benefits The Public benefits from certified personnel: Develop and preserve clinical research standards Improve human subject protection Create more efficient studies Increase credibility of the clinical research process 22

23 Certification Results Feedback from pharmaceutical companies and clinical sites suggests there may be: Fewer errors Improved cost-effectiveness Accelerated process time Increased study subject safety Accelerated program completion Accelerated NDA/PLA/BLA approvals 23

24 CPI Exam Exam offered twice per year: March & September Offered in over 30 locations in North America Offered in 10 international sites, including Tokyo, Taiwan, Ahmedabad, Dubai, Kenya and Johannesburg 2008 dates will be available soon on the web at 24

25 Conclusions Certification of professionals is a significant step in enhancing Clinical Research quality Important for Investigator to be certified-leader of the team and responsible person Certification should include personnel both inside and outside companies APPI and ACRP encourage worldwide certification of professionals and are pleased to cooperate with other organizations and groups in making this happen 25