Clinical Drug Trials
Clinical Drug Trials- An Overview
Clinical drug trials are controlled studies conducted under FDA regulations to test the efficacy and effects of a new drug before it is released for clinical use.
While most trials are carried out ethically, with patient safety in mind, even the most well-intentioned trials may result in serious side effects, patient injury, and even death. These damages may be the result of negligence, malpractice, patient confusion, or the intentional withholding of information.
THE RISK OF CLINICAL TRIALS
- The new treatment being tested may not be as effective or as safe as existing treatments.
- Drugs and medical devices in clinical trials may carry unexpected side effects.
- These side effects may be occasional aches and pains or may result in serious adverse events including renal injury, cardiovascular complications, and even death.
- As the clinical trials progress, drugs may be combined with other medications and dosages may be increased, resulting in increased risks.
- Insurance and health care providers may not cover the costs of patient care during a clinical trial or injuries and side effects that may result from a clinical trial.
HAVE YOU BEEN INVOLVED IN A CLINICAL TRIAL
If you have been involved in a clinical trial and have suffered injury or illness, ask yourself the following questions:
- Did you understand all of the enrollment paperwork you signed?
- Were you confused by the consent forms?
- Did you have lingering questions about side effects?
- Did your doctor fail to explain all the possible outcomes of the trial?
- Were you told you had a problem and then told something different by another doctor?
- Were you referred to several doctors during your initial treatment and/or after the trial?