Clinical trials are conducted to collect data on the safety and effectiveness of new medications and medical devices. There are several stages of approval in the clinical trial process before a drug or device can be sold in the consumer market.
Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. When laboratory research is successful, researchers send the data to the country’s regulatory agency (ex. Health Canada or Food and Drug Administration (FDA) for US,) for approval to continue research, and to test in humans.
A new medicine must pass through several kinds of trials in humans before it can be marketed. Lambda conducts some of these trials in healthy and patient volunteers.
The following types of studies are performed here at Lambda:
- Bioavailability or Bioequivalence studies where the amount of drug in your blood over the course of the study (Bioavailability) is measured. This study is performed to compare a generic drug to a Brand drug that is already available on the market.
- Phase I Safety Studies – These studies are performed to evaluate the safety of a drug that is in development. In a Phase I study, it may be the first time a drug may be introduced to human volunteers, or where new dosage amounts are being tested (ex. dose escalation).
- Phase II or patient studies, the goal in these studies is to see how the drug performs in patients with the target disease condition (is it effective).
All our studies are conducted in accordance with Health Canada regulations and International guidelines.
When you participate in studies you may be part of a group of volunteers who would stay in our supervised clinical facility for few days, take medication, with blood samples collected at timed intervals. We do studies on weekends, during the week, and sometimes for extended periods of time (ex. For several days at once).
For most of our studies, we are looking for healthy volunteers, 18 years of age or older, who are:
- free of daily medication
- non-drug users
Some studies have special requirements and look for volunteers who are:
- Post Menopausal or Surgically Sterile
- A particular race (ex. Caucasian)
- Have a particular disease or condition (ex. Hepatitis, ulcers)
Safety & Precautions:
Each study is governed by a protocol reviewed and approved by the Research Ethics board (REB) and Health Canada. REB is an independent committee that has been formally designated to approve, monitor and review research involving Humans. REB members have a primary mandate to safeguard the rights, safety and well being of all volunteers. . Protocols outline the details of a study including how it will be carried out, what testing is required to ensure the safety of volunteers, what data will be collected, description of the study drug.
Volunteers go through one or more Informed Consent processes for a study, to ensure that they have all the information necessary to make an informed choice about participating in research studies. The Informed Consent documents include details about the conduct of a study, drug information, risks, responsibilities and expectations. Informed Consents undergo REB review and approval to ensure transparent communication of study details, and volunteer rights and expectations. Volunteers can choose to stop participating in a study at anytime.
For more information regarding studies that are currently seeking volunteers, click here.
For more information on studies at Lambda, visit our FAQ, here.