Have you been diagnosed with a rare disease and there is no known cure for it? Do you believe in the power of research and you are excited to participate in it? Or are you motivated by altruism and you want to contribute to something larger than you? Then Clinical Trials are for you.
What Are Clinical Trials?
Everything must go through Clinical Trials before being approved by the FDA. In these research studies people volunteer to test new medicine, devices or treatments. Clinial Trials can be funded publicly or privately. Each year, thousands of people join Clinical Trials and help millions with their dedication.
Before you Decide to Participate in a Study
• Make sure you fully understand the study, its procedures and requirements.
• Ask any questions you may have about the study before or during the visit.
•Take your time, read the application form carefully (or have it read to you), and ask the study doctor or staff any questions you may have.
•Do not sign it until you understand all of the information, and until all of your questions about the research study have been answered.
• Note, that you should be given a copy of the application form to keep.
•Discuss your potential involvement in this study with family, friends and preferred medical professional.
•Always consult your General Practitioner. With your permission he/she should be informed of your participation in the study.
•There may be some medications you are not allowed to take and your study doctor should discuss more about this with you.
Special Terms in Clinical Trials
You may hear special terms during the study, let’s get familiar with them.
“Double-blind”
A “double-blind” study means that the study doctor and the participants won’t know which group is administered the study drug and which group is administered placebo. This way, the results of the two groups will be treated equally. Neither you nor the study doctor will know which group you are in, but this information can be obtained in case of an emergency.
“Placebo controlled”
“Placebo controlled” means that the study drug will be compared with placebo. A placebo looks like the study drug but does not contain any active medication. One group of participants will take the study drug and another group will take the placebo. The effects seen in participants taking the study drug will be compared to the effects seen in participants who are taking the placebo.
“Randomized”
“Randomized” means that you will be assigned by chance (like the flip of a coin) to receive study drug or placebo. You will have an equal chance to receive either study drug or placebo. Neither you nor the study doctor can choose which group you will be assigned to.
What Can You Expect?
The length of involvement may depend on several factors, including the type of the trial, the research topic, number of people involved, etc.
It may include:
>the screening period: the team checks your eligibility and current state -the double-blind treatment period
>the follow-up visit
• In certain cases you may also need to have a caregiver who can attend visits with you and who will also complete questionnaires.
• Documentation of demographic information (your race, gender, ethnicity)
•You should provide information about your medical/surgical history, prior and current medication
• A full physical examination
•Vital sign measurements (blood pressure, pulse rate, respiratory rate and body temperature).
• You will be required to give a urine sample which will be used for routine tests, including screening for some prohibited substances.
Don’t Forget Your Rights
- Discuss with your General Practitioner
- Note that your participation is voluntary. If you decide to participate in the study and later feel that you no longer wish to be part of it, you have the right to withdraw at any time.
- Make sure you have got all the information about the possible Risks and Discomforts, that can arise. Note, that in case of an experimental product there may be still unknown side effects.
- Qualified health professionals will monitor your health as it relates to the study.
- Your records, your participation in the study and any other information are strictly confidential.
Benefits to Participation in Clinical Trials
If you receive the treatment and it is effective, it may improve your symptoms. If it’s a double-blind study, there might be a chance, that you re- ceive placebo. In this case there is no additional benefit beyond that provided by your usual care. However, information learned from the study may help other people in the future, while advancing medical research.
