Clinical Research

Clinical research in humans is the final, most crucial, stage of the drug development process. Here, the safety and efficacy of innovative medicines are studied in human subjects.

Merck Frosst Canada imposes the highest standards on its clinical research and has a complex system of checks and balances that ensures all studies are safe and objective. The company also complies with strict guidelines set by Health Canada's Therapeutic Products Program (TPP), the Declaration of Helsinki, the International Conference on Harmonisation (ICH) Guidelines, and the US Code of Federal Regulations which together set the standards for all facets of ethical human research.

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Clinical research can take 10 years or more, costs hundreds of millions of dollars, and involves thousands of patients and hundreds of researchers both in Canada and abroad. Specialists, from physicians and nurses at the trial sites, to Merck Frosst professionals who manage the sites and data, stake their reputations on conducting the most ethical and high-quality research.

Each clinical research program follows a well-defined path, with regulatory approval at every step of the way. With the approval of the TPP, medicines found to be safe and effective in animals are tested first in healthy volunteers, then in patients with the target disease, and then in the large-scale clinical trials that are the hallmark of pharmaceutical research. Post-marketing trials including Clinical Evaluation Programs (CEPs), designed to provide a broader experience with the new drug after it has received regulatory approval, round out the process.

Clinical trial participants are recruited by physicians, usually through their practices, by patient chart reviews and by advertising. Participants are fully informed of all aspects of the trial and must sign a consent form. Although patients are not paid to take part, they are reimbursed for their out-of-pocket expenses.

Merck Frosst Canada is currently participating in many clinical trials, many of which are international in scope involving many countries in almost all regions of the world. In international trials all countries taking part conduct the same study using the same protocol, the same procedures for informed consent, and require the same approval from local ethics committees. All data are monitored and audited according to the same high standards, allowing the results to be used in regulatory filings anywhere in the world. For example, the development of SINGULAIR® (montelukast sodium), a Canadian discovery, involved an international clinical research program that generated safety and efficacy data of sufficient quality to support regulatory approval in close to 80 countries.

However, conducting clinical research at home remains a priority for Merck Frosst Canada. Canadians are recognized around the world as exceptional clinical subjects, primarily because they follow procedures faithfully and take the medications as requested. With dedicated patients and impeccable research standards, trials by Merck Frosst Canada are well respected throughout the world.

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