Human Resource and Educational Inventories to Support the Life Cycle Approach to the Regulation of Therapeutic Product

Executive Summary

Introduction

Health Canada has undertaken to modernize the legislation and regulation of pharmaceuticals and biologics. This will facilitate the ongoing monitoring of safety, effectiveness and quality throughout the life cycle of drug products. The life cycle phases will include pre-market applications, authorization and entry onto the market, and post-market surveillance on the safety and effectiveness of these products in the real world environment. This report is the outcome of a study commissioned by the Office of Legislative and Regulatory Modernization, Health Products and Food Branch, to evaluate whether the human resource capacity in Canada is sufficient to support the product life cycle approach to drug regulation. The project objectives were to:

• Establish and characterize the current human resource capacity in Canada able to conduct post-market drug safety and effectiveness studies; and
• Identify and describe the programs in Canadian post-secondary educational institutions able to train graduate students in post-market drug evaluation research methodology.

Study findings will provide a baseline for how to approach the change management aspects for the implementation of the product life cycle approach to drug regulation.

Methodology

Project development was a collaborative effort by the Office of Legislative and Regulatory Modernization, Health Products and Food Branch in Ottawa (David K. Lee (Director); Dr. Maurica Maher (Associate Director); and Robyn Brake (Project Coordinator)) and Dr. Stuart MacLeod, Executive Director of the Child and Family Research Institute (CFRI) in Vancouver. The design, conduct, management and dissemination of the project was carried out by the CFRI Working Group based in Vancouver, comprised of Dr. Stuart MacLeod (Executive Director, CFRI; Associate Dean (Research), Faculty of Medicine, University of British Columbia); Dr. Judith Soon (Senior Policy Research Officer, Policy, Planning and Outreach, Regions and Programs Branch, Western Region and Assistant Professor, Faculty of Pharmaceutical Sciences, University of British Columbia); Dr. Sunaina Sharma (Head, Policy, Planning and Outreach, Regions and Programs Branch, Western Region and Senior Advisor CFRI and Stakeholder Liaison); and Dr. Matthew Wiens (Research Assistant and Clinical Pharmacotherapy Specialist, Fraser Health Authority). The Peer Review Committee, composed of ten leading academic and professional experts from across Canada, provided ongoing advice on the conduct of the research and dissemination of study findings. Peer Review Committee members were Drs. Jean-Paul Collet (University of British Columbia); Jean Gray (Dalhousie University); Jean-Pierre Grégoire (Université Laval); Andreas Laupacis (University of Toronto); Jacques LeLorier (Université de Montréal); Colleen Maxwell (University of Calgary); Yola Moride (Université de Montréal); Robert Peterson (University of British Columbia); Jeff Poston (Canadian Pharmacists Association); and Noralou Roos (University of Manitoba).

Preliminary results of the human resource and educational institution inventories were presented to stakeholders and Peer Review Committee members during a one day workshop in Montreal, Quebec on April 18, 2009. Participant perspectives on the interim findings, practical suggestions for addressing future human resource capacity needs in Canada and discussion on ways in which Canadian researchers can contribute to the harmonization of international surveillance programs have been incorporated into this report.     

The target population for the inventory of academic and health care institutional researchers was those involved with the post-market drug surveillance of safety and effectiveness utilizing clinical, epidemiological, economic and outcomes research methodology. The search strategy progressed in three phases:

• Phase 1: Individual researchers identified through universities, health care settings and funding agencies for pharmaceutical research were invited to participate;
• Phase 2: Personal contacts within professional health care organizations were invited to forward the invitation to members involved in drug evaluation research; and
• Phase 3: External Scientific Database Managers in the three Health Canada Directorates involved in post-market drug evaluations were invited to forward the invitation to key researchers.  

An online survey instrument was designed to characterize the demographics, training and research expertise of academic and clinical researchers involved with post-market drug evaluation. Information was also gathered on the involvement of researchers in past and current consultations with Health Canada, interest in future post-market drug evaluation research and inclusion in a Registry of Post-Market Drug Evaluation Researchers, and barriers to data access that limited post-market drug evaluation research. The survey was pilot tested, and ethics approval was provided by the Research Ethics Boards at Health Canada, the University of British Columbia, and the Children's and Women's Health Centre of British Columbia. 

The inventory of educational institutions capable of training students in the discipline of post-market drug evaluation research was web-based, with telephone follow-up where appropriate. All health-related graduate programs that taught courses in epidemiology and biostatistics were eligible, as well as graduate programs in epidemiology, public health, pharmacy, veterinary medicine and health informatics. The prevalence of relevant courses was summarized by institution and the estimated number of graduate students calculated. The six core training courses deemed essential for future post-market drug product evaluation were Epidemiology, Biostatistics, Health Economics/Pharmacoeconomics, Pharmacoepidemiology,  Pharmacogenetics/Pharmacogenomics and Patient Safety/Risk Management, with pharmacovigilance being included in the latter category.

Summary of Key Findings:

1. Inventory of Post-Market Drug Evaluation Researchers

Characteristics of Academic and Health Care Researchers

• Demographics: The survey identified 354 researchers in eight Canadian provinces who were actively involved with drug evaluation research. Respondents were most frequently employed as a faculty member in an educational institution, a physician/clinician in a health care setting or a researcher in an academically-affiliated research centre, including academic hospitals. Male respondents were more likely than females to be over the age of 45 years.
• Research Training: While 139/354 (39%) of the respondents were academically-trained researchers (e.g., MSc, PhD), a high proportion of health care clinicians also had post-graduate training. Among the 147 physicians, 69% had additional post-graduate research degrees, and of the 55 Doctor of Pharmacy (PharmD) trained clinicians, 36% had post-graduate research degrees. The majority of respondents received their research training in Canada.
• Clinical, Methodological and Special Population Expertise: The diverse credentials of the respondents are reflected in the varied areas of research expertise. While four of the six core areas of expertise deemed critical to future post-market drug evaluation (Epidemiology, Biostatistics, Health Economics/Pharmacoeconomics and Pharmacoepidemiology) were frequently documented, Pharmacogenetics/ Pharmacogenomics and Patient Safety/Risk Management/Pharmacovigilance were rarely reported.  Among special populations, research expertise involving marginalized populations and aboriginal peoples' health was low.
• Professional Organization Best Aligned with Research Interests: Four professional organizations, the Canadian Association for Population Therapeutics, Canadian Association for Health Services and Policy Research, Canadian Medical Association and the Canadian Society of Hospital Pharmacists reflect the primary clinical and methodological affiliations of the multidisciplinary respondents. These professional organizations have the potential to facilitate ongoing communication between Health Canada and active researchers. 
• Pre-Market Authorization Drug Evaluation Research Experience: Among respondents involved with post-market drug evaluation research, 130/354 (37%) also have been involved with pre-market authorization drug evaluation research within the past five years. Researchers with pre-market authorization drug evaluation experience were more likely than researchers only involved in post-market drug evaluation research to be male, over 45 years of age and a physician based in a hospital/health care facility. In addition, these researchers more often have expertise in active comparator trials and clinical trial design, supervised graduate students, developed practice guidelines and consented to participation in the private sector registry (e.g., industry, contract research organizations).
• Post-Market Drug Evaluation Research Experience: 285/354 (81%) of respondents had participated in post-market drug evaluation research within the past five years, most frequently in areas related to pharmacoepidemiology, adherence to drug therapy and health policy research. Methodological expertise was often noted in pragmatic real world observational studies, population health database studies and systematic reviews, all of which are central to future post-market drug safety and effectiveness research. In the broadest sense, many respondents who stated that they were not involved in post-market drug evaluation research are indeed actively engaged in closely related areas of research and have comparable academic credentials and research expertise as those who stated that they were involved. Thus, the findings of all respondents who answered the survey have been included in this report, to better inform readers on the scope and depth of researchers in this area of research.
• Graduate Student Supervision: 169/354 (48%) of respondents were actively supervising graduate students.  Among survey respondents, the Université de Montréal, the University of British Columbia and the University of Toronto were the top three universities training MSc and PhD researchers in this area.  A total of 283 MSc and 215 PhD students are currently in the process of completing graduate training across Canada.
• Knowledge Translation Strategies: While the traditional academic strategies of peer-reviewed publications and conference presentations continue to be frequently used, relatively new knowledge translation mechanisms such as educational sessions with decision-makers, collaborative research involving end users throughout the research process, summary briefings to stakeholders and electronic dissemination (e.g., webinars) are now recognized as fundamental components of knowledge translation and exchange strategies. 

Past and Potential Future Involvement with Health Canada

• Knowledge of Proposed Life Cycle Approach to the Regulation of Drug Products: Only 142/354 (40%) of respondents reported being aware of the proposed regulatory modernization to the Food and Drugs Act, and of those, 42/142 (30%) had contributed to consultations in the past and an additional 20/142 (14%) had provided other forms of feedback (i.e. 62/354 (18%) of all respondents). 
  
  The findings from this human capacity resource survey suggest that there is considerable clinical and academic expertise among Canadian researchers actively engaged in post-market drug evaluation research. Attracting new researchers to become engaged in Health Canada consultations and providing new opportunities for feedback may facilitate ongoing support for the life cycle approach to drug regulation.  
   
• Barriers to Data Access: 147/354 (42%) of respondents reported onerous barriers to data access that impeded timely post-market drug evaluation research.  Key issues identified included lack of timely and affordable accessto population health data; lack of funding for primary data collection surveillance initiatives; lack of transparency related to pre-authorization and post-market data submitted to Health Canada by drug manufacturers; and burdensome personal health information legislation at a provincial level that has often created substantial challenges for accessing patient data.
• Interest in Potential Research Opportunities with Health Canada: 306/354 (86%) of respondents were interested in pursuing future research possibilities in the drug safety and effectiveness area. Among survey respondents, 82%consentedto be included in a Health Canada registry, 77% consented to a public sector registry (e.g., governments, institutions), 75% to a not-for-profit registry (e.g., organizations, research networks) and 53% to a private sector registry (e.g., industry, contract research organizations). This reluctance to share expertise with the private sector suggests future impediments to successful life cycle product review driven as a primary responsibility of commercial sponsors.

2. Inventory of Educational Institutions

• Institutions, Programs and Qualifications: Twenty-three Canadian institutions have the potential to train students in post-market drug evaluation research, of which 21 have human health-related programs.  Across the country, 31 MSc and PhD thesis-based degree programs are available, with an additional 19 post-BSc non-thesis Masters programs graduating students in various related disciplines. Approximately 500 thesis-based MSc and PhD students graduate annually, with an additional 400 non-thesis Masters graduates.  Given the breadth of programs available, likely only a minority of students actually receive training specific to post-market drug evaluation research in these graduate programs.
• Prevalence of Core Courses by Institution: The prevalence of the six core courses essential for training in post-market drug evaluation was determined for the 23 educational institutions: Epidemiology (23); Biostatistics (21); Health Economics/ Pharmacoeconomics (15); Pharmacoepidemiology (4); Pharmacogenetics/ Pharmaco-genomics (4); and Patient Safety/Risk Management/Pharmacovigilance (4). While no institution offered all six courses, four institutions (McGill University, Université Laval, Université de Montréal and the University of Ottawa) offered five of the core courses.  A diverse range of health-related non-core courses are also offered, which varied widely by educational institution.

Specific Recommendations

We recommend that:

1. Health Canada extend this human resource capacity survey of post-market drug evaluation researchers to provincial and federal governments, the not-for-profit sector, and contract research organizations to more accurately inventory post-market drug evaluation researchers, as many are working outside of academia and health care institutions.
2. Health Canada support a Task Force to develop a national syllabus that would guide universities interested in training highly qualified personnel able to support post-market drug evaluation studies, as few universities currently offer a comprehensive training program that focuses on all of the essential core courses.
3. Health Canada act to increase awareness of career opportunities that support post-market drug evaluation. To encourage these targeted recruitments, consideration should be given to the development of a national scholarship program for highly qualified personnel in this specialized research field. A national web-based distance education program may facilitate graduate student training in post-market drug safety and effectiveness research methodology, by enabling the utilization of highly trained Faculty members currently based at a limited number of universities.  
4. Health Canada should foster effective partnerships and networking between academia and government on drug safety and effectiveness research through evidence-based practice centres modeled along the lines of the virtual Canadian Institute for Advanced Research.
5. Health Canada, in partnership with the Canadian Institutes of Health Research, should administer funding for Canada Research Chairs in Therapeutic Risk Management in selected Canadian post-secondary institutions to encourage the development of additional expertise needed in this area.
6. Health Canada, in partnership with the Canadian Institutes of Health Research, should develop strategies to improve capacity in post-market drug evaluation research targeted at marginalized populations and aboriginal peoples' health in order to promote the health of all Canadians.
7. Health Canada, in partnership with the Canadian Institutes of Health Research, should facilitate international exchanges between highly qualified researchers in the area of post-market drug evaluation (e.g., European Medicines Agency) to encourage the uptake in Canada of progressive strategies in the area of drug safety and effectiveness research.
8. Health Canada should actively explore procedures that would enable sharing of population-based data across provincial boundaries, thus reducing barriers to data access and facilitating population health research relevant to optimal therapy.