Participate in a study

Clinical research provides direct information about  health and disease. Without it we would not have the effective new treatments we have today for diseases such as cancer,  diabetes and chronic obstructive pulmonary disease.  By participating in a clinical trial, you can play a more active role in your healthcare and contribute to better health for everyone.

To qualify for participation in clinical trials,  you must meet  guidelinesbased on factors such as age, gender, type of disease, medical history, current medical conditions and medication usage. 

There are five types of clinical trials:    

• Prevention  clinical  trials   explore  better  ways  of  preventing  subjects  from  developing  a  medical condition  or  look  to  prevent  a  medical  condition  or  disease  from  reoccurring. 
• Screening  clinical  trials  are  used  to  determine  the  most  effective way  of  detecting  medical  conditions  or  diseases. 
• Diagnostic  clinical  trials  are  utilized  to  find  better‐quality  tests  or procedures  for  diagnosing  a  medical  condition  or  disease. 
• Treatment  clinical  trials   test  investigational  and/or marketable  drugs,  surgical  procedures,  devices,  behavioural treatments, dietary  interventions and  process‐of‐care  changes. They also  test the  effectiveness  of  new  combinations  of  treatments. 
• Quality  of  life  clinical  trials  are  often  used  to  seek  out  new  ways to  improve  the  comfort  and  quality  of  life  for  patients with chronic  medical  conditions or  diseases. 

Clinical trial phases can be best broken down into four questions: 

• Is the treatment safe? 
• Is the treatment effective?
• Is the new treatment more effective than existing treatments?
• Is there a better way to use this new treatment? 

The first three questions involve investigational clinical trials, meaning that the treatment is only accessible to clinical trial participants and has not been approved by any governing regulatory agencies for use in the general public. 

Phase 1: Is the treatment safe?

The first step in a clinical trial is to test the safety, dosage levels and response to a new treatment.  Phase 1 clinical trials are often conducted with a small number (20 to 100) of healthy volunteer subjects to evaluate the safety of a treatment by identifying the best way to administer it (i.e. by mouth, intravenous infusion or injection), to how and how often to administer it and to identify possible side effects across the dosage range. In the case of a clinical drug trial, the drug is examined to determine how it is absorbed, metabolized and excreted, and in some cases to obtain early evidence on the drug’s effectiveness.

Phase 2: Is the treatment effective?

Once a treatment has been proven safe and well tolerated in healthy volunteer subjects, the next step is to test it in patient subjects with the medical conditions or diseases in which it is expected to work.  In addition to further testing the safety of the treatment in the patient population, Phase 2 clinical trials evaluate its effectiveness anddetermine the correct dosage that will produce the least number of side effects with the most effective results.  For that reason, Phase 2 trials are often called “dose-ranging studies”.  They can last anywhere from a few weeks to a few months to a few years. They usually involve several hundred participants and are often designed as well controlled, randomized trials, meaning that one group of subjects receives the experimental treatment and the other group receives a control treatment which can consist of a standard treatment already in use  or a placebo.  Placement of a patient subject into the experimental or control treatment is by random chance (like a flip of a coin).  Often Phase 2 clinical trials are double-blinded, meaning that both the patient subject and researcher  are unaware of which specific treatment group a patient subject has been assigned to.   Typically only a small portion of Phase 1 and Phase 2 clinical trials are successful and eventually go onto Phase 3.

Phase 3: Is the new treatment more effective than existing treatments?

Phase 3 clinical trials are mostly used to determine if a new treatment is more effective than the standard treatment options that are currently in use by increasing the survival and quality of life of patient subjects and reducing the incidence and severity of side effects  and possible risk of reoccurrence of the condition or disease.  In this type of clinical trial, the new treatment is tested in several hundred to several thousand patient subjects.  Most Phase 3 clinical trials continue to be randomized and double-blinded studies.  This large-scale testing allows for a more thorough understanding of the treatment’s effectiveness, associated benefits and risks, and range and severity of possible adverse side effects, thereby allowing governing regulatory agencies to determine if the treatment is marketable and should be allowed to be used in the general public.

Phase 4: Is there a better way to use this new treatment?

Phase 4 clinical trials, more commonly known as “post-marketing surveillance studies”, primarily examine the long-term efficacy, safety and toxicity of already approved marketed treatments that might not have been apparent during the testing of the Phase 3 clinical trial.  The goal of these types of clinical trials is to get a better understanding of the treatment that has already been proven to work.  Thousands of patient subjects usually participate in these types of clinical trials.  A Phase 4 trial can also be used to show that a specific treatment is more effective if it’s given for a longer period of time, or that a lower dose of the treatment works as well as a higher dose, but with fewer side effects.

Clinical trials are registered in the public domain.  If you are interested in finding out more about clinical trials being conducted in the Kingston, Ontario, please visit the following clinical trial registries with websites providing searchable databases of clinical trials.  Use key words like “Kingston, Ontario”, “Kingston General Hospital” and/or “Queen’s University”:

For all types of clinical trials, please visit:

• www.clinicaltrials.gov

• www.ISRCTN.org  

For cancer clinical trials: www.ontariocancertrials.ca 

For allergy clinical trials: www.eeu.on.ca