WHAT IS THE PURPOSE OF DRUG TRIALS SNAPSHOT?
The FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. In addition to information about who participates in the trial, each Snapshot also includes information on how the study was designed, results of the efficacy and safety studies and, if known, differences in efficacy and side effects among sex, race and age (referred to as subgroups).
FDA is posting six examples that represent approvals for drugs that treat a broad range of diseases. These drugs were approved over a two month period in 2014. We are seeking feedback from the public on the content, format and overall usability of the first six Snapshots. Beginning next year, we intend to post a Snapshot for every NME and original biologic we approve.
WHY IS THIS INFORMATION IMPORTANT?
The FDA does not conduct clinical trials. Rather, pharmaceutical companies seeking to market a drug complete a series of tests and submit evidence to the FDA that the drug is safe and effective. The Drug Trials Snapshot highlights who was in the clinical trials and whether various demographic groups were part of the consideration of safety and efficacy in applications submitted to the FDA. Physicians and scientists at the FDA use this information to decide if the benefits of the drug outweigh the risks before it’s approved for use in the general population.
HOW CAN I USE THIS WEBSITE?
Stand-alone conclusions regarding the efficacy and safety among different sex, race, and age groups could not always be made, usually because the numbers of patients in some groups were too low to allow for a meaningful comparison to the overall result. Therefore, interpretations of subgroup data must be made with caution, because findings in one direction or another are often inconclusive. In cases where stand-alone conclusions could not be drawn, this does not necessarily mean a drug doesn’t work or is unsafe in that subgroup. Patients should always speak to their doctors or health care providers about individual risks and benefits before taking any prescribed treatment.
SHARE YOUR THOUGHTS
The FDA wants your comments on the format, content and overall user friendliness of this site. Please share what you think about the Drug Trials Snapshots page and help to improve this website by submitting comments to: regulations.gov.
TERMINOLOGY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
| Clinical Trial Demographic | Active Ingredient | Original Approval or Tentative Approval Date | What It’s Used For | Drugs@FDA Label |
|---|---|---|---|---|
| DALVANCE | dalbavancin hydrochloride | May 23, 2014 | Serious bacterial skin infections known as acute bacterial skin and skin structure infections (ABSSSI) | Dalvance drug label |
| ENTYVIO | vedolizumab | May 20, 2014 | Crohn’s Disease | Entyvio drug label |
| ENTYVIO | vedolizumab | May 20, 2014 | Ulcerative Colitis | Entyvio drug label |
| JUBLIA | efinaconazole | June 6, 2014 | Fungal infection of the toenails (onychomycosis) due to two common forms of fungi | Jublia drug label |
| SIVEXTRO | tedizolid | June 20, 2014 | Serious bacterial skin infections known as acute bacterial skin and skin structure infections (ABSSSI) | Sivextro drug label |
| ZONTIVITY | vorapaxar | May 8, 2014 | People who have had a heart attack or reduced blood flow in their legs (peripheral arterial disease) | Zontivity drug label |