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Clinical Research
Updated April 26, 2008
What is clinical research?

Clinical research is an integral part of the drug development process. It involves systematic measures used to assess the safety & efficacy of new medicines in human subjects. Often the clinical study or clinical trial compares the new treatment (commonly referred to as "investigational drug") under evaluation with a placebo (an inactive substance designed to resemble the drug being tested) or the current standard treatment.
Clinical Trials: Any systemic evaluation of new medicines in human subjects whether in patients or healthy volunteers to discover or verify the potential benefits and and/or identify any adverse reactions or side effects to the new drug.
How are clinical trials executed?

Clinical trials are executed in four distinct phases (steps) designed to answer specific research questions. Each phase of the clinical trial has a specific goal and the information gathered is used to build knowledge on the new drug and support the subsequent phases of the drug development process.
Phase I Study

The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small groups of healthy volunteers (20-80) to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study

After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals (100-300) who are afflicted with the disease or condition for which the drug was developed.
Phase III Study

The third and last round of testing of a new drug is conducted on large populations of afflicted patients (1,000-3,000). Phase III studies usually test the new drug in comparison with a placebo or the standard therapy currently being used for the disease in question. The compiled results from the Phase I to Phase III studies are used to support the application to market the new drug submitted to the regulatory agencies (for example the U.S. FDA and Health Canada). The results of the Phase III trials usually provide the information that is included in the package insert and labeling once the new drug is marketed.
Phase IV Study

After a drug has been approved by the FDA and/or Health Canada, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse reactions or side effects.

All phases of clinical trials are executed according to a pre-established protocol or study plan. All protocols in Canada are conducted according to Good Clinical Practices (GCPs)

Good Clinical Practices (GCPs)
: is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. The first initiative to comply with GCPs as an international ethical and scientific standard was undertaken by the European Union (EU), Japan, and the United States. This first initiative was the basis for a unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Although Canada was not part of the first initiative, it is now mandatory for all clinical trials to be conducted according to GCPs in Canada.
Before a protocol can be put into practice, it must obtain two levels of approval: Health Canada (national regulatory agency) and an independent Ethics Committee. Approval at these two levels ensures that the protocol is scientifically sound, that it adheres to GCPs and local regulations and that the safety of the participant is not jeopardized (i.e. the potential benefits outweigh the risks associated with the new drug). Ethics committees can be local such as an Institutional Review Board (IRB) at a hospital or university, or central such as an independent Ethics Review Committee (ERC). Both IRBs and ERCs are composed of an independent group of professionals designated to review and approve the clinical protocol, Informed Consent Forms, study advertisements, and patient brochures to ensure that the study is safe and effective for human participation.
Prior to entering a clinical trial, subjects must sign an informed consent.

Informed Consent: The process of verifying and documenting that a study participant willingly accepts to participate in a clinical trial. The informed consent is signed only after the subject has received complete, objective information about the clinical trial, including its objectives, potential benefits, risks and inconveniences, alternative therapies that may be available (if applicable), and the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki. The subject' s rights to confidentiality (in compliance with PIPEDA) while participating in a clinical trial is also covered in the informed consent. The informed consent also has the provision to inform the subject of any new information which is made available during the course of the clinical trial which may affect his/her continued participation in the study. The informed consent also specifies that participation in the clinical study is voluntary and that the subject can choose not to participate or can leave the clinical study at any time even after he/she has consented to participate. The informed consent is not a contract and the participant is not bound in any way. In sum, the rights of the person are safeguarded and protected at all times.
What is PIPEDA?

The Personal Information Protection and Electronic Documents Act (PIPEDA) is part of the Canadian Privacy Law and establishes principles for the collection, use, and disclosure of personal and identifiable information that is part of commercial activity (e.g. physician practice's, pharmacies, private labs, pharmaceutical companies, etc). PIPEDA requires obtaining consent for the collection of personal and identifiable information, informing study subjects of their privacy rights and providing them with an opportunity to know what personal information is being collected, for what purpose, how it will be used, disclosed, and protected.
This information provides a general overview of the clinical trial process in Canada. is meant to support, not replace the relationship between patients & doctors. One should always consult a family physician or specialist before participating in a clinical trial.
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