Quality Care

Clinical Trials

En Español |

Points to consider

CLINICAL TRIALS STAGES

  • Stage I: Tests the safety of the substance or device in a human.

  • Stage II: Tests the safety and efficacy of the medication in a human at different dosage levels.

  • Stage III: Tests the efficacy of the dosage level selected between patients who do receive the drug and patients who don’t. The comparison is done in randomized controlled trials, where half of the patients receive the new drug and half receive a placebo or current gold-standard treatment.

  • Stage IV: Once the drug has been approved by the FDA, monitoring of the drug is required on a group of patients to determine side effects and drug interaction.

 QUESTIONS FOR YOUR PROVIDER

  • If the medical treatment is no longer effective, are there any FDA approved treatments suggested by EBM?

  • If there are no other treatments, should I join a clinical trial?

  • Which trial is the most effective?

  • Which trial has shown the least side effects?

  • What criteria is used to determine whether a consumer needs to exit a clinical trial and when?

  • Where can I find a second opinion about this trial?

  • How to enroll, how to finance it, and where is it provided?

  • How can I receive other financial assistance like lodging?

  • If any injuries occurr during the trial, will someone provide assistance?