WE OFFER PATIENTS PHASE I, II AND III CANCER CLINICAL TRIALS AT GCRI. PLEASE MAKE A CONSULTATION APPOINTMENT TO SEE IF YOU QUALIFY FOR ONE OF OUR CLINICAL TRIALS. WE WILL ALSO HELP YOU FIND THE BEST AVAILABLE CLINICAL TRIAL(S) FOR YOUR SITUATION ANYWHERE IN THE US.
What are clinical trials? Before a new drug is approved by the governing regulatory agencies such as the FDA in the US or the EMA in Europe and become available to patients with a prescription, the drug has to undergo years of clinical evaluation in patients to (1) determine the correct dose, schedule and route of administration in humans which is safe and tolerable and identify the side effects of the new drug (Phase I), (2) determine its efficacy (whether it works and how well it works at reducing the tumor size) in a well-defined patient population, such as non-small cell lung cancer after failed first line therapy (Phase II), and (3) confirm the drug's efficacy and safety in a larger patient population defined in the Phase II trial (Phase III). Once a new drug's efficacy and safety profile are confirmed in typically a large randomized Phase III trial, the clinical data from the trial conducted with the new drug will be reviewed by the country's governing regulatory agencies (ie, FDA in the US or EMA in Europe), and if the benefit to patients outweigh the side effects of the new drug, the new drug gets approved and becomes available to all patients by prescription through their doctors. Sometimes, a new drug can get approved with data from a Phase II trial, but that usually requires significant responses in tumor size reduction as a result of treatment with the new drug, minimal side effects from the new drug, and a disease indication where there is a huge unmet medical need for which there are no other approved treatments available.
Today, more than 50% of cancer patients can be cured with conventional treatments – that is, therapies with a proven response rate and/or survival benefit based on clinical trial results. However, many patients who do not respond to standard approved treatment may be eligible for participation in our Phase I, II and III clinical trials program.
The only way that new drugs are evaluated and get approved for patients is to first be studied in clinical trials in patients with cancer. This is the first step in finding the next cancer cure......