Clinical trials are only one part of clinical research. Clinical research is a term that describes many different aspects of scientific inquiry. It involves human subjects, turning research done in labs into treatments and information to benefit patients. In addition to clinical trials, some research in the areas of epidemiology, physiology and pathophysiology, health services, education, outcomes and mental health can also be part of clinical research.
There is still a lot that researchers don’t know or understand about diabetes. Most research begins in animal models, such as worms, zebra fish, and mice; and it needs to be determined how much of this research can be applied to humans. Clinical trials provide the platform to advance this basic research from the laboratory, to the patient. Only the most promising experimental treatments are moved into clinical trials, which are conducted in set phases.
Clinical research is desirable to study patients as it provides them with access to the newest, most cutting edge diabetes products and treatments. Without clinical research often times these products and treatments would not be available to many patients.
A clinical trial is conducted using a plan also known as a protocol. The protocol is designed to answer a specific question while protecting the participants health and safety. A protocol includes a description of who is eligible to participate in the clinical trial, what tests, procedures, and medications will be used, and how long the trial will run. A clinical trial is led by a principal investigator, who is most often a doctor. They are supported by their research team who regularly follow up with the participants to determine the efficacy and safety of the protocol.
Clinical Trial Phases
There are several phases of a clinical trial. Each phase contributes new knowledge about the investigational drug or intervention bringing it one step closer to being a prescribed medication for population use.
Clinical Trial Phases
- Phase I – This is a study where the investigational drug is tried in healthy humans for the very first time. They are short duration studies of a few months and recruit a small number of subjects in order to assess the best dosage and any potential side effects.
- Phase II – At this point, there are some known doses and side effects of the investigational drug. It studies the safety evaluation of investigation drug in several hundred subjects for a longer duration and comparing several doses. Knowledge of the impact of the drug and side effects is expanded.
- Phase III – These trials generally recruit 1000 or more subject. Typically, a phase III trial is conducted only after the investigational drug seems to show promising results in phase I and II. Sometimes the study drug is compared to a control/placebo (inactive substance) or common standard therapy for further evaluation of safety and efficacy.
- Phase IV – The U.S. Food and Drug Administration (FDA) or Health Canada has approved the drug. As such, these are post-marketing studies comparing approved drug to a) a competitor, b) in a more diverse population or c) to further study side effects.
Research must be conducted systematically and this involves various standards, regulations and legislations that must be followed. The responsible conduct of research will ensure a research site’s success.
There are many steps involved in adding a successful, recognized diabetes research program to your clinic.
Research in Canada
Canadian researchers have made ground-breaking contributions to diabetes research and treatment. Of note, the discovery of insulin occurred in Toronto in 1921 by Banting and Best. For more information on the facility that harbours this discovery Banting and Best Diabetes Centre
Further, the Edmonton Protocol islet cell transplantation has made notable contributions in the novel treatment of diabetes. The future of research in Alberta and Canada for diabetes looks promising!
To read more about the Islet Cell Transplantation Program at the University of Alberta see here
For more on research in Canada visit the Canadian Diabetes Association
There are several ways that funding may be possible for future diabetes research. This can occur through industry-funded initiatives, government and other public sectors (for example, post-secondary institutions). It is important to reach out to your local diabetes industry and pharmaceutical representatives to put you in contact with their regional research manager for funding support opportunities. This is a great way to learn about each company’s ongoing clinical research trials that you may want to be a part of. Often these representatives are more than happy to help you and your clinic with establishing the necessary tools for running a research trial.
For more information on funding, please see:
Please note that this is not an exhaustive list.
Ongoing Clinical Trials
Please see www.clinicaltrials.gov for all ongoing research studies worldwide.