Monday, September 22, 2014 



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Frequently asked questions

1. What is clinical research?
2. What are clinical trials?
3. How is clinical research different from medical care?
4. Why is clinical research important?
5. Who can participate in a clinical trial?
6. What happens during a clinical trial?
7. What are the benefits and risks of participating in a clinical trial?
8. How is the safety of the participant protected?
9. What is Informed Consent?
10. What should people consider before participating in a trial?
11. Does the participant continue to work with their primary health care provider while in a clinical trial?
12. Where do ideas for clinical trials come from?
13. Who pays for clinical trials?
14. How does clinical research progress?
15.Where can I get more information?


1. What is clinical research? - top
           
Clinical research is the stage of medical research that involves human volunteers. Typically, this stage comes after experiments in cell cultures and animals (often referred to as ‘basic research’). Clinical research is often conducted through clinical trials.

2. What are clinical trials? - top

Clinical trials are research studies in human volunteers designed to answer specific health questions. Carefully conducted clinical trials are the fastest and safest ways to evaluate new treatments for patients and to improve health care. There are two main types of clinical trials:

  • Interventional trials compare different treatments, different methods of diagnosis, or new ways of using therapies.
  • Observational trials address health issues in large groups of people or in populations in a natural setting.

Clinical trials can have a number of goals, including:

  • Testing a new treatment to determine how it performs compared to a mock treatment (also called placebo or sugar pill)
  • Testing a new treatment to determine how it performs compared to a treatment currently in use
  • Looking for causes of a disease or a condition
  • Determining the impact of a disease or an intervention on a patient’s quality of life
  • Determining the best way to prevent a disease
  • Determining the best way to diagnose a disease
  • Determining the prognosis of a disease, i.e., what is likely to happen to a person with respect to survival time or time to development or progression of a disease

3. How is clinical research different from medical care? - top

The main difference between the medical care you receive every day from your physician and clinical research performed by your physician is in their goals. The main goal of medical care is to prescribe the best known course of treatment for an individual person but the main goal of clinical research is to answer a question by testing the alternatives in different groups of people. The treatment that you will receive in a clinical trial is based on a set of rules called a protocol. The protocol describes in great detail how you will be treated, what tests you will receive and when you will visit your physician. Because clinical trials often require the collection of more data than would be required for routine care, people in clinical trials often receive closer monitoring and more frequent visits with a physician. It is a requirement for there to be a health care professional, often a physician, who is in charge of a clinical trial at every centre in which that trial is performed. This individual is referred to as the Principal Investigator at that site. There is always a principal investigator for the overall clinical trial, as well, but that individual may not be at the site at which you receive your care.

4. Why is clinical research important? - top

Without clinical research it would be very difficult and in some cases impossible to gain useful knowledge about diseases and conditions in humans. With the information gained through clinical research, we can learn the causes of diseases, as well as how to prevent, how to treat, and in some cases, how to cure them. In addition, the federal government agencies that oversee development of new drugs require that clinical research studies be done before new drugs are approved for sale by prescription or over-the-counter use. This requirement for trial review and registration ensures the scientific integrity of research. Without clinical trials, it would be very difficult to improve patient care in any regard.

5. Who can participate in a clinical trial? - top

The protocol mentioned in Question 3 not only outlines the schedule for patient care but also indicates who can participate. Studies must have well-defined inclusion and exclusion criteria to produce reliable results. Some clinical trials involve participants with specific illnesses or conditions, while others involve healthy volunteers. It is important to note that inclusion and exclusion criteria are not used to reject people personally and are not a statement about the individual themselves. The criteria are used to identify appropriate participants, to keep patients safe, and to help ensure that researchers will be able to answer the questions they are concerned about.

6. What happens during a clinical trial? - top

The clinical trial process depends on the kind of trial being conducted. As you might expect, your health status at the beginning of the study is carefully assessed in most cases. Specific instructions for participating in the trial are provided and in general, the research personnel will make sure that you follow these instructions. You will be monitored carefully during the trial and in some cases research personnel will stay in touch after the active part of the trial is completed. For example, you may receive a drug for a period of time but then you must be observed for a much longer period of time after the drug has been stopped, in order to understand how it has affected your health. Many clinical trials involve more tests and doctor visits than you would normally have. These visits and tests have been carefully determined in order to ensure that the maximum amount of information can be gained from the clinical trial.

It is important to note that in many clinical trials, patients will be randomly assigned to receive different treatments, or to receive a mock treatment (placebo or sugar pill). Participants usually won’t know which treatment they are receiving, and in some cases, their physician will not know either. These are called “double-blind” studies, and they are designed to eliminate the potential effects of human bias on the results. While the investigators do not know which individuals belong to which treatment groups, they (or an independent group of experts) are still able to compare the groups and monitor trends on a general level. This is essential because a trial may have to be stopped if side effects are deemed too dangerous. Trials may also be stopped if the experimental treatment is proven to be far superior to the standard treatment. In this case, all participants would be offered the experimental treatment.

7. What are the benefits and risks of participating in a clinical trial? - top

While the specific benefits and risks of each individual study will vary, the following points will hold true in general:

Benefits:

  • Clinical trials that are well-designed and well-executed provide an opportunity for eligible participants to play a more active role in their own health care.
  • Clinical trials provide access to experimental treatments before they are widely available.
  • Participants will obtain expert medical care at leading health care facilities during the trial.
  • Clinical trials help others by contributing to medical research. In many cases, especially today with increasing numbers of trials assessing genetics, the people who benefit may include your family members.

Risks:

  • There may be unpleasant, serious or even life-threatening side-effects to experimental treatments.
  • The experimental treatment may not be effective for the participant.
  • The treatment may be effective, but the participant may be assigned to a group that does not receive the treatment (i.e. they may receive a placebo or sugar pill).
  • The protocol may require more of your time and attention than routine medical care.

8. How is the safety of the participant protected? - top

All clinical trials must be approved by a Research Ethics Board (also called an Institutional Review Board). This process is designed to ensure that the rights and welfare of participants are protected. It is also designed to ensure that the goals and approach of the study are scientifically valid and appropriate. Research Ethics Boards contain experts in medical care, research, and ethics, as well as non-expert representatives from the community.

Note that in some cases, the results of a trial will be monitored by an independent audit group (see Question 6). Individual participants’ names and identifiers will not be made available in reports of research studies.

9. What is Informed Consent? - top

You will be asked to read and sign a form called an Informed Consent before participating in a clinical trial. The consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It also provides a written summary of the study and the problem to be evaluated. Consent forms include:

  • The purpose of the study
  • The names of the drugs, treatments, or diagnostic evaluations involved
  • An outline of the schedule of visits and testing required
  • Any costs or payments to you
  • The risks and / or benefits of participation
  • Alternatives to participation

You should ask the research personnel to explain anything you do not understand in the Informed Consent. In general, informed consents are written with plain language to ensure that everyone can understand what is involved with the study. By signing the consent form, you are agreeing to participate in the study but it is not a contract and you may withdraw from the study at any time. The informed consent will have been reviewed by a Research Ethics Board, which makes sure that the rights and welfare of research subjects are protected (see Question 8).

10. What should people consider before participating in a trial? - top

People should know as much as possible about the clinical trial and feel comfortable asking members of the health care team questions. These questions may include:

  • What is the purpose of the trial?
  • What is usual care and how successful is usual care?
  • Why do researchers believe the new treatment being tested may be effective?
  • What tests has it undergone already?
  • How do the possible risks, side-effects and benefits in the study compare with current standard treatments?
  • How might the study affect daily life and how long will the trial last?
  • Will hospitalization be required?
  • Are there any personal expenses for which I will be reimbursed?
  • Who is in charge of my care?

In addition, you should feel free to ask the Investigator whether they will benefit financially from your being in the trial. In general, this should be mentioned in the consent form, but this is not always the case.

11. Does the participant continue to work with their primary health care provider while in a clinical trial? - top

This will depend on what your illness is and what the trial is. In general, clinical trials are short-term treatments related to a specific problem and do not provide the extended or complete primary health care usually provided by a family doctor or General Practitioner (GP). Furthermore, there are benefits from having your primary GP work with the research team, as the GP may have a better understanding of your overall health needs.

12. Where do ideas for clinical trials come from? - top

Ideas for clinical trials usually come from medical practitioners who have a good understanding of important health care issues and who are also specially trained in clinical trial design. Many potential therapies or procedures undergo testing in the laboratory and in animals, but only the few that are most promising make it to the clinical trial stage. If care for a disease was perfect, it is unlikely that a clinical trial would be performed. In other words, clinical trials are usually performed because it is felt that the care provided to patients can be improved upon.

13. Who pays for clinical trials? - top

Clinical trials may be sponsored or funded by a variety of sources, including:

  • Federal agencies such as the Canadian Institutes of Health Research (CIHR)
  • Foundations such as the National Cancer Institute of Canada
  • Hospitals, research institutes and universities
  • Pharmaceutical companies

14. How does clinical research progress? - top

Clinical trials are generally conducted in Phases from I to IV. Phase I involves evaluating a new treatment in a small number of patient or healthy volunteers. These trials are often designed to evaluate side effects and establish an appropriate dose, rather than to evaluate effects on disease progression. Phases II and III involve the testing the treatment in larger groups of people over longer periods of time. If these clinical trials generate enough evidence to show that the treatment is safe and effective, the sponsor may apply for Health Canada’s approval to market the treatment. Phase IV trials, which are performed after a drug has been approved, are designed to provide additional information regarding the drug’s risks, benefits, and optimal use.

15. Where can I get more information? - top

Your physician or health care provider is the most appropriate person to answer any questions you may have about a specific clinical trial. Later this year, the OHRI and The Ottawa Hospital will begin listing active clinical trials on this website, but in most cases, your family physician or specialist must still refer you to the clinical trial organizers (i.e. it is not possible to contact the clinical trial organizers yourself). If you are interested in participating in a clinical trial, you may want to direct your family physician or specialist to this website.

To gain a better understanding of some of the terms used in clinical research (and in this document), it may be helpful to search through this clinical research glossary:
http://www.centerwatch.com/patient/glossary.html.


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