Clinical Research
The Research Process
The most crucial step in the development of a new medicine is the point at which it enters into clinical trials and is finally tested in humans. The clinical development program for a drug is divided into several phases — a careful, step-by-step approach that makes safety a priority (see Phases of Clinical Trials). Each phase consists of several trials. This page briefly outlines how individual trials are carried out by Merck Frosst Canada.
Phases I to IV
The Clinical Research Group of Merck Frosst Canada is mainly involved in Phase II and III trials designed centrally by the company's US parent, Merck & Co., Inc.
The design of a clinical trial program often involves consultation with the US Food and Drug Administration (FDA) to ensure that the right types of trials are conducted and the right endpoints collected.
Once Merck Frosst Canada has committed to a clinical program, the protocol is submitted to Health Canada's Therapeutic Products Program (TPP) for review, and potential investigators are approached. Merck Frosst recruits only physicians whose clinical research meets the high standards of Merck and Co., Inc. have access to the necessary facilities, and have a suitable patient population. Contracts are signed that define a budget, publishing agreements and patient confidentiality. Investigators are compensated — particularly for time spent with patients — to ensure that the health-care system is not billed for any study procedure. Before patient recruitment can begin, each investigator must receive approval from his or her local ethics committee.
During the study, Merck Frosst medical monitors check that all data are recorded accurately, and that all adverse events are documented fully. Serious adverse events, such as a death, or an event that requires hospitalization, are reported immediately to Merck Frosst, which forwards the reports to Health Canada, ethics committees, and eventually to all sites involved in a trial with the same molecule. It was this strictly managed process that first identified problems with MK-679, the predecessor of SINGULAIR® (montelukast sodium), and quickly led to the abandonment of further testing in humans.
As data is transferred from the clinic to our database there is a system of checks and audits that ensures integrity of the information. The outcome of this highly structured process is impeccable study results that are assembled into a new drug submission.
Because of its complexity, there are many pitfalls that can significantly slow a development program, and which are only avoided by careful planning, guided by experience.
A Notice of Compliance (NoC) marks government approval in Canada, but the research does not stop there. Phase IV trials continue to collect safety data, and new clinical programs investigate other indications and other patient populations.
CEPs
Clinical Evaluation Programs collect Canadian data on the real-world experience with a new drug after it is marketed. Physicians recruit patients under a standardized protocol after ethics approval, and collect survey feedback. This data adds to the growing body of knowledge and provides a valuable opportunity for clinicians to confirm the safety and efficacy profile of the new drug under supervised conditions. These programs also allow us to gather Canadian pharmacoeconomic and epidemiologic data.
®Registered Trademark of Merck & Co., Inc. Used under license.
Information and things to do in Montreal
Click here
