Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered, e.g., TB

Life Sciences, Clinical Trials, Pharmaceutical,
  • Friday, January 18, 2013

The outbreak of new infectious diseases on a global scale such as SARS, swine flu (H1N1), avian flu (H1N5), received wide press coverage and caused panic in the general population. As of November 30, 2012, there were nine confirmed cases of a SARS-like illness in the Middle East, five of which were fatal. When the next pandemic is due is unknown, but it is only a matter of time before the next pandemic is a reality. Simultaneously, infectious diseases such as TB, polio, rubella, pertussis, etc., are on the rise in developing countries as well as the West.

Phase 1 research typically involves confinement of volunteers in a group living setting, sometimes for extended periods, thus putting them at risk of exposure to communicable disease carried by fellow subjects or clinic staff. First-in-humans research with compounds targeting the immune system, or special populations such as the elderly or those with renal or hepatic impairment, represent even greater potential risks.

Health Canada has long recognized the risks, and has developed stringent infectious disease screening requirements for Phase 1 clinical trials. Dr. Klein will discuss Health Canada’s approach and requirements. Dr. Larouche will discuss the practical dimensions of the problem, and what must be done at the clinic level, over and above regulatory requirements.


Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of RadioPharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada

Agnes V. Klein MD, DPH, is currently the Director, Centre for the Evaluation of RadioPharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate.

After receiving her medical degree from the University of Toronto, Dr. Klein trained in Endocrinology, Medical Biochemistry and Public and Community Health. Subsequently, after joining Health Canada, she has occupied many and varied scientific and management positions Canada and its Amongst relevant accomplishments, Dr. Klein represented Health Canada on NCBHR, as founding member and on NCEHR as well as chairing the Committee on Clinical Trials of the Council. In 2000, Dr. Klein moved from the Drugs side of the regulatory Directorates to Biologics and was at the forefront of many of the changes that shaped the current Biologics and Genetic Therapies Directorate.

Dr. Klein’s special interests include the appropriate design of clinical trials and the various and complex ethical issues attendant to the design and conduct of clinical trials and other studies in human subjects. Dr. Klein was a member of Health Canada’s Research Ethics Board, and continues her involvement with that REB as a senior advisor. She is an active member of several medical and scientific organizations nationally and internationally.

Dr. Klein has also supervised several graduate students under various student programmes related to Health Canada, especially under the graduate Masters’ and PhD candidates at the Université de Montréal. She has also been part of the Departmental mentoring programme: several of her mentees attained senior management and strategic positions. Dr. Klein has also hosted and supervised Health Sciences Management Development candidates who were then successful in developing their policy and strategic acumen.
Dr. Klein has multiple interests and was instrumental in championing the first Paediatrics Guidelines of any regulatory agency as well as the first Guidelines for the inclusion of Women in Clinical Trials, as far back as 1995.

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Dr. Richard Larouche, BPharm, MD, Director, Medical Affairs,Early Stage Development, Pharmanet/i3

Richard Larouche, MD, B.Pharm, Director, Medical Affairs oversees the medical team in Early Stage Development and is responsible for insuring the safety of all subjects at our Clinical Pharmacology Unit. After having developed his clinical experience as a pharmacist, emergency physician and family physician, he joined the Pharmaceutical industry over a decade ago.

At PharmaNet/i3, he has been the leading investigator in various early phase clinical trials in healthy volunteers and patients such as: First in Human, SAD-MAD, Drug-Drug Interaction, TQT, Renal Impaired, Insulin Clamp, PK-PD and phase IIa. Dr. Larouche completed advanced training in clinical trials at Vanderbilt University and also holds a certificate in Human Pharmacology from King’s College of London.

He has been deeply involved in design and conduct of all innovator compound studies performed at PharmaNet/i3 for the last 13 years. He still works as a family physician in a community medical clinic.

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Who Should Attend?

Senior Researchers, Investigators, IRB Administrators, and individuals responsible for research performance and oversight at research sponsors, organizers, CROs and SMOs.

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Institutional Review Board Services™ (IRB Services), established in 1993, is a wholly independent company with ethics boards and knowledgeable staff in both Canada and the USA. We are the only independent IRB designated by the Minister of Health to review research in the province of Saskatchewan.

IRB Services is a service-driven organization striving for excellence in human research participant protection. We are committed to providing efficient and effective customer-oriented services by:

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Being advocates, in the research community and with peers, regulators and the public, for the ongoing evolution of these standards
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