From Regulatory Compliance to Competence in Clinical Research

Transcription

1 From Regulatory Compliance to Competence in Clinical Research The Joint Task Force for Clinical Research Competency Initiative Stephen A. Sonstein, PhD Director, Clinical Research Administration Eastern Michigan University Presented to: 11/17/2015 1

2 Expected Learning Outcomes Recognize the evolution of clinical research as an academic discipline Recognize the growing relevance of competency based education and training in career development Describe the outcomes of the Joint Task Force (JTF) initiative to define the Core Competencies in Clinical Research Describe the preliminary lessons learned from an international initiative to validate the JTF Core Competencies 2

3 Drug and device development is one of the most highly regulated activities globally Governmental regulatory authorities FDA OHRP ICH GCPs IRB/IEC Pharmacovigilance Comparative efficacy vs cost

4 Personnel w ho conduct clinical trials Very general requirements In most countries, anyone with a medical license can conduct clinical trials.irrespective of their experience or education in clinical research Little detail in regulatory authority definitions of criteria required for responsible individuals ICH The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-todate curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies)

5 Personnel w ho conduct clinical trials Declaration of Helsinki Previous 3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent. Revised (2014) 12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

6 The Harsh Reality of Clinical Research Sites Today 70% of clinical research sites never do more than one clinical trial in the business lifetime Fewer than half of sites meet enrollment goals and 10% never enroll a single subject Few sites have professionally trained and certified research personnel Many sites are still using paper records without EDC/CTMS Monitoring accounts for nearly one-third of clinical trial budgets Redundancy, delays, non-compliance, and poor quality are the norm rather than the exception 6

7 D eficiencies and Opportunities Clinical Investigator Deficiencies. CDER Inspections Khin NA et al. Clin Pharmacol Therap,2013; 94,2:230 Enhancing the quality of clinical trials Improved trial design principles Defined personnel roles and responsibilities Improved policies and procedures Improved study start-up Quality assurance and auditing Document management Improved adverse event reporting Record retention Perspect Clin Res Oct-Dec; 2(4): Education and Training 7

8 What are we expecting when we hire a clinical research professional? Principal investigator Any licensed physician anywhere in the w orld can serve as Principal Investigator CRC there are no educational requirements CRA there are no educational requirements Regulatory Affairs Professional there are no educational requ irem ents How do we differentiate between an entry level and an advanced level professional? What criteria do w e use to justify promotion? 8

9 Evolution of Education and Training in Clinical Research Activity Informal training: coaching, tutoring Short term courses: how to do it! Professional bodies (training, support) Discipline Academic involvement: Standards and competencies Formal Curriculum: short and long term programs N ational accreditation and certification Profession International Standards/Harmonization of Training/mutual recognition International Certification/Specialization Maintenance through CPD Honorio Silva MD,

10 Moving the clinical research enterprise from a focus on regulatory compliance to professional competence How to do it? Systematic harmonization and broad based acceptance of job descriptions and performance outcomes for the m any roles that exist in the clinical research enterprise Standardization and Documentation of ed u cation/ training and experience in clinical research Requ ired personnel certification Accreditation of the sites which conduct clinical trials 10

11 Traditional Vs Outcomes Based education TRADITIONAL EDUCATION Based u pon know led ge Time fixed; Learners grouped in classes and m ove together Teachers are responsible for a course Learners accumulate courses and grades leading to a cred ential Defined competencies are im portant OUTCOMES BASED ED UCATION Based upon competencies Time is variable Learners advance in various w ays to achieve outcomes Teachers are responsible for a set of outcomes Learners demonstrate achievement of outcomes at their own pace Defined competencies are a paradigm 11

12 Competency vs. Competence Competencies encompass knowledge, skills, attitudes, and behaviors necessary for a particular set of tasks or objectives in a specific job/function Are usually organized in clusters (d om ains) Can be measured (assessed) Can be improved A competent professional is one possessing the required abilities in all domains in a certain context at a defined stage of education or practice. (Frank J. Medical Teacher, 2010) 12

13 Use of competencies Competency profiles Competency-based education and training Job p rofiles linked personnel profiles Level of competency vs level of job Self-assessm ent & com petence Com petence & career d evelopm ent Gap analysis Training to fill gaps Continuous process (competence not static, jobs change, gaps appear); lifelong learning 13

14 Competence: Self-Assessment What competencies do I need for my work & what are the gaps? What learning opportunities can help me? How can I consolidate the learning & become competent? 14

15 The Joint Task Force for Clinical Trial Competency Organized under the sponsorship of MRCT and ACRES at Harvard University. Supported by MAGI, DIA and ACRP Included representatives from industry, academy and nonprofit organizations Agreed to work toward aligning and harmonizing the many more focused statements relating to core competencies for clinical research professionals into a single, high-level set of standards which could be adopted globally and serve as a framework for defining professional competence throughout the clinical research enterprise 15

16 Joint Task Force for Clinical Trial Competency Contributors and Collaborators Representatives met in person or via TC during the period October 2013-June 2015 JTF Coordinators: S. Sonstein and R. Li 16

17 Outcomes of the JTF on Core Competencies in Clinical Research 51 specific competencies within the 8 domains derived from the pu blished and presented efforts of specific related grou ps Based u pon cognitive param eters Not expected that each member of the clinical research enterprise is competent in all Still need to be leveled as Expert, Com petent, N ovice Hope is that Harmonized Core Competencies will be utilized as a basic fram ew ork for job d escriptions and job portfolios Sonstein, S.A., Seltzer, J., Li, R., Jones, C.T., Silva, H., Daemen, E. (2014, June). Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clinical Researcher. 28(3)

18 Harmonized Core Competency Domains for the Clinical Research Professional 18

19 A cooperative multi-institutional effort The JTF International Validation of Core Competencies and Educational N eeds Assessment 19

20 Initiative in final stages Globally distributed questionnaire including demographics, domains and competencies. Respondents were asked to share their own perception of competence, role relevance and needs for training utilizing the JTF Core Competency Domains and statements Data to be used for: Needs assessment for training Stand ard ization of position d escriptions Integration into personnel and site certification efforts Valid ation and id entification of key com petencies Stand ard ization of cu rricu la for acad em ic program s - complete statistical analysis currently ongoing. 20

21 D emographics by region and function Role # Clinical Research Coordinator/Research Nurse 338 Research Administrator/Project Manager 229 Principal Investigator/Coinvestigator 228 Europe 20% Latin America 41% Clinical Research Associate/Monitor 129 Regulatory Affairs Professional 52 Educator/Trainer 50 US/CAN 35% Pharmaceutical Physician/Medical Director 42 Data Management Professional 38 Others 107 Total 1213 ONLY 366 CERTIFIED 21

22 Scale of Self-Assessed Responses to Perception of Competence and job relevance Competency Key: 0 Never been exposed to this content 1= Aware of the content, but never needed to become further informed; 2= Exposed and sufficiently aware of content that I can look up what might be necessary for my job; 3= Competent Able to interpret or discuss concepts and use knowledge to solve simple problems based on application concepts; 4 = Mastery able to apply knowledge to complex problems, integrate information and create solutions Relevance Key: 0 = unnecessary, no relevance to my role; 1 = has some relevance to my role, but not my responsibility; 2 = relevant to my role, but not a major component; 3 = significant to my role and part of my job responsibilities; 4 = major part of my responsibility or supervisory expectations 22

23 Criteria for Competency Relevance to Role Percentage of responses rated 3 or 4 1 High Relevance - >80% 2- Significant Relevance 60-79% 3- Intermediate Relevance 40-59% 4- Low Relevance 20-39% 5- No relevance - <20% Applied to both domains and specific competencies. 23

24 Self-assessment of Competence, Relevance and Training Needs - Overall N=1213 Domain Scientific Concepts & research design Self Assessment of Competence (%) Relevance to the job (%) Additional Training Needs (%) Ethics & Safety Medicines Dev. & regulations Clin. Trials Ops Study & Site Mgmt Data Mgt & inform Leadership & professionalism Communication & Teamw ork

25 Perception of Competence and Relevance by Role Domain Relevance to Role (% 3-4) Competency (%3-4) PI CRA CRC RM PI CRA CRC RM Scientific Concepts and Research Design Ethical and Participant Safety Considerations Medicines Development and Regulation Clinical Trial Operations Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork

26 Perceived need for training by role Domain Need for Training (%yes) PI CRA CRC RM Scientific Concepts and Research Design Ethical and Participant Safety Considerations Medicines Development and Regulation Clinical Trial Operations Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork

27 Specific Competency and Relevance to CRC s by years of experience Competency (% 3-4) Relevance (%3-4) Years of Experience Ethical and Participant Safety Considerations Compare and contrast clinical care and clinical management of research participants (317) Define the concepts of clinical equipoise and therapeutic misconception as they relate to the conduct of a clinical trial (315) Compare the requirements for human subject protection and privacy under different national and international regulations and ensures their implementation throughout all phases of a clinical study (315) Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key documents which ensure the protection of human participants in clinical research (313) Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards (314) Evaluate and apply an understanding of the past and current ethical issues, cultural variation and commercial aspects on the medicines development process (313) Explain how inclusion and exclusion criteria are included in a clinical protocol to assure human subject protection (313) Summarize the principles and methods of distributing balancing risk and benefit through selection and management of clinical trial subjects (313)

28 CRC - Perceived competence, relevance and training need by location Domain Location N Competence Relevance Training % 3+4 % 3+4 % yes Scientific Concepts and Research Design US/Can LA WE AA Ethical and Participant Safety Considerations US/Can LA WE AA Medicines Development and Regulations US/Can LA WE AA Clinical Trial Operations US/Can LA WE AA Study and Site Management US/Can LA WE AA Data Management and Informatics US/Can LA WE AA Leadership and Professionalism US/Can LA WE AA Communication and Teamwork US/Can LA WE AA

29 Conclusions Performance deficiencies in the clinical trial process are not only costly, but contribute to delay and risk in the medicines d evelopm ent process 2. Competency rather than compliance is the currency by which we should be measuring the conduct of clinical research and medicines d evelopm ent 3. Competency based education is emerging as a paradigm for ed u cation and training in health professions 4. The JTF has developed a Harmonized Framework of Core Competencies for the Clinical Research Professional and a global survey aimed at validation, perception of competence, relevance to the job and educational needs was recently completed. Final results are expected soon. 5. Preliminary data show differences in the perception of competence, relevance and need for training for the various functions and competency domains. The significance of such differences is to be determined.

30 Next Steps Finalize analysis of collected data, and continue with internal/ external d iscu ssions w ith stakehold ers Ongoing validation and collaboration with the NIH CTSA netw ork Fu rther regional/ cou ntry valid ation Formalize the ACRP role as Custodian Adoption of key competencies for accreditation of academic program s Create global aw areness for fu rther ad option and ad aptation Devise an effective com m u nication strategy Id entification of job profiles and portfolios. 30

31 Thanks for your attention! Q & A 31