New medications and treatments must be proven safe and effective for human use before doctors are permitted to write prescriptions for them. Through clinical trials, also known as research studies, researchers can evaluate new investigational drugs. A clinical trial is a study done by researchers to test the safety and effectiveness of new investigational drugs, devices, or procedures.
Clinical trials are a necessary step in the process of making new drugs available to patients. These research studies, which allow pharmaceutical companies and the government to determine the safety and effectiveness of new compounds, are essential for the advancement of medical science.
Participating in a clinical trial is a personal decision. Here is a list of questions you should ask.
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Here you will find many answers to common questions our patients and clients have about CRI Lifetree. To see an answer to a question, simply click on the question and read on.
A clinical trial is a research study designed to test a specific medication, therapy, or treatment. The clinical trial design and objectives are written into a document called a clinical trial protocol. Each study varies in length and the number of study visits.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate.
This document describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant decides whether or not to sign the informed consent document. This is not a contract and the participant can withdraw their participation at anytime.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In clinical trials involving placebo, an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
On your first visit, you will fill out a medication/medical history; you will then see one of our physicians so this and other information can be reviewed. If you qualify for a particular study, a study coordinator will sit with you to explain the informed consent document with you. --Purpose, duration, required procedures and key contacts
Most clinical trials require you to meet with the physician for follow up visits. The number of follow up visits is determined by the specific study. If no follow up visits are required by the study we will schedule you with one of our physicians anyway.
The information collected in a clinical trial is completely confidential and your identification information will not be released to the pharmaceutical company sponsoring the study. After the study is complete all of the data will be analyzed to determine if the study drug is working, whether it is safe, and if it has any side effects. Medical advisers closely review the information before approving any drug.
Many research studies compensate participants to help offset any out-of-pocket expenses that may be incurred during their participation (e.g., parking, travel, lodging expenses, baby-sitting costs).
The amount of compensation is determined by the sponsor and reviewed and approved by an Institutional Review Board/Independent Ethics Committee.