1. WHO CAN PARTICIPATE IN A CLINICAL TRIAL?
All clinical studies have guidelines regarding who can participate. Before joining a clinical study, a research subject must qualify for the study. The factors that allow participation in a clinical study are called “inclusion criteria” and the factors that disallow participants from being involved in a study are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses and/or conditions to be studied in a clinical study; while other studies require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers obtain the appropriate information they are needing.
2. HOW DOES A CLINICAL TRIAL WORK?
In a clinical study, a research subject is usually assigned a specific study group. One study group may receive an investigational treatment/drug while the other study group may receive a placebo or a treatment already available on the market.
A placebo is an inactive product used to assess the experimental treatment effectiveness. The research subject, physician, and research staff may not know which subject receives the placebo and which receives the active treatment. Not knowing which research subjects are receiving the active treatment allows the physician and research staff to objectively observe the research subjects during the study. Regardless of which treatment each participant receives, the level of medical attention and care that each receives is the same.
3. DIFFERENT PHASES IN CLINICAL TRIALS?
None of the existing treatments result in a cure of all patients, nor are they without side effects. Doctors and research advocates continue to look for better ways to treat the disease. Clinical trials are organized into different phases of research in order to build up a greater understanding of the new treatment/drug before it is approved or recommended for routine use to the FDA (Food and Drug Administration).
Clinical trials are also organized into different phases of research, in order to build up a greater understanding of the new treatment, before it is approved or recommended for routine use.
Phase I – is the first time an experimental therapy/drug is given to humans. This is performed with small numbers of subjects, usually healthy participants, and are used to answer questions such as what dose of the drug is likely to be effective and what side effects might occur.
Phase II – this phase continues the process with a larger number of participants who have the medical condition that the experimental therapy/drug is intended to treat. It focuses more on the effectiveness of the experimental therapy/drug and it continues to further evaluate its safety.
Phase III – in this phase, enrollment increases once more and participants are used to compare the effectiveness and safety of the new therapy/drug with that of the standard existing treatment or a placebo. This is the final step before seeking approval from the FDA (Food and Drug Administration).
Phase IV – last phase, also know as the “post-approval” or “post-marketing” phase. Pharmaceutical companies may continue to monitor participants to compare the new therapy/drug in terms of its safety, effectiveness, and cost – to other therapy/drugs already on the market or assess a therapy/drug’s long-term effectiveness and its impact on the quality of a person’s life.
4. WHAT QUESTIONS SHOULD WE ASK WHEN CHOOSING TO PARTICIPATE?
- How long will the trial last?
- Where is the trial being conducted?
- What treatment(s) will be used and how?
- What is the main purpose of the trial?
- How will patient safety be monitored?
- Are there any risks involved?
- What are the possible benefits?
- What are the alternative treatments besides the one being tested in the trial?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
5. VOLUNTARY PARTICIPATION
You will never be enrolled in a clinical trial without giving written consent to participate. You can, for any reason, decide not to continue to take part in the trial and your doctor will then offer you the existing treatment for your particular condition.
You can withdraw from a clinical trial, without explanation, at any time.
6. DOES INFORMATION REMAIN CONFIDENTIAL AND PRIVATE?
YES! All information is to remain confidential and private. Access to personal information is available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and/or the sponsor doing the clinical trial will also have access to certain personal information. This is explained in more detail in the consent form that participants are asked to sign before being enrolled into a study.
7. WHAT HAPPENS AFTER THE TRIAL?
After a clinical trial is complete, the data is collected to determine if the drug’s effectiveness and safety is medically beneficial. Depending on the results, researchers then determine whether to stop or extend testing OR move to the final phase of study, which is submitting to the Food and Drug Administration (FDA) for approval.
If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug in terms of its safety, effectiveness, and cost – to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.