Things to Know before Participating in a Clinical Trial
Clinical trials are controlled studies that require human participants to test the efficacy and effects of a medical device or new drug before it is approved for clinical use. While there are benefits to participating in a clinical trial, many things should be considered before treatments begin.
What is the Purpose of the Clinical Trial?
Not all clinical trials are out to test a potential cure for a condition the participant may be suffering from. On the contrary, most clinical trials are conducted for the sole purpose of research and collecting scientific data.
Informed Consent in a Clinical Trial
- Informed consent is meant to be the first step in patient safety.
- During this process, the patient should not only be provided with information of the potential benefits of a clinical study, but also the risks that are included as well. These risks may be something as simple as occasional discomfort or may include serious long term side effects including heart problems, renal injury and death.
- During this time, the researcher should also provide any information of alternative treatments that have already been FDA approved and clinically available.
- A patient should not sign a consent form if they feel that they have not received all the necessary information or if they feel confused by the information provided.
- Participants should also remember that a consent form is in no way a contract. A patient may withdraw from a clinical trial at any time during the study without penalty.
What if Issues Should Arise during a Clinical Trial?
Participants should continue to see their regular physician or healthcare provider throughout a clinical trial. This will help to prevent any conflict with other treatments, and will work as a verification of what a patient is told during a trial.
- Researchers may not request that a patient discontinue interaction with their current health care professionals.
- Should serious side effects arise or injuries occur, a participant should receive the necessary treatment. If any additional costs are the patient's responsibility, they should have been made clear during the consent process.
- In the event of injury resulting negligence, malpractice, or withholding of information, those responsible should be held accountable.
Contact an Experienced Clinical Trial Attorney
If you suffered injury or developed serious side-effects from a clinical trial and feel you were not properly notified of the risks associated with the study, contact Thomas J. Henry immediately. Thomas J. Henry are leaders in the area of clinical trial litigation and possess the experience and resources to represent you effectively and aggressively.