It is very important to test drugs and medical products in people they are meant to help. Otherwise, we will never know how effective they really are. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
Why participate in a clinical trial?
People volunteer to participate in clinical trials for different reasons. Some people participate in clinical trials because they have exhausted standard treatment options - which either did not work for them, or they were unable to tolerate certain side effects. Other people participate in trials because they want to contribute to the advancement of medical knowledge and help others better understand how the treatment works in people of different races and genders.
By taking part in a clinical trial, you can try a new treatment that may or may not be better than those that already exist but in any case, clinical trials may provide another option when standard therapy has failed.
In other words, participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have strict guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". All criteria are included in the study plan. To find out if someone is eligible for a particular study, he or she needs to talk to the doctor in charge of enrolling patients for the study.
These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. Not everyone who applies for a clinical trial will be accepted. For example, volunteers may be excluded based on the inclusion criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.
Should you participate in clinical trial and what should you think about before joining a clinical trial?
Patients or healthy volunteers considering participating in clinical research should talk about it with their physicians and healthcare professionals. It is important for people to ask questions before deciding to enter a clinical trial. The more curious you are, the better you understand the risks and benefits. You will also be able to properly manage your own expectations and be able to participate in the clinical trial you choose. People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it.
For example, questions to ask may include:
The clinical trial (study)
What is the main purpose of the study?
Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
Who is sponsoring the study?
Who has reviewed and approved the study?
What are the medical credentials and experience of the researchers and other study personnel?
What will my responsibilities be if I participate?
How will patient safety be monitored?
How long will the trial last?
What will happen at the end of the study?
What are the alternative treatments besides the one being tested in the trial?
Possible risks and benefits
What are the possible short-term benefits?
What are the possible long-term benefits?
What are the short-term risks, such as side effects?
What are the possible long-term risks?
What other treatment options are available?
What happens if I am harmed by the trial?
Participation and care
What kinds of treatment, medical tests, or procedures will the participants have during the study? How often will they receive the treatments, tests, or procedures?
Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
Will participants be able to take their regular medications while in the clinical trial?
Where will the participants receive their medical care? Will they be in a hospital? If so, for how long?
Who will be in charge of the participants’ care? Will they be able to see their own doctors?
How long will participants need to stay in the study? Will there be follow-up visits after the study?
How often does the study require me to go to the doctor or clinic?
How might this trial affect my daily life?
Will your participation remain confidential and private?
How will I know that the treatment is working? Will results of the trials be provided to me?
May I choose to continue this treatment after the study ends?
Cost issues
Who will pay for the treatment?
Do I have to pay for any part of the trial?
Will I be reimbursed for other expenses?
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