How Drugs Get From the Test Tubes to Us, Part 5
The option of doing a clinical trial “makes decisions a little more complicated. Otherwise, all you’d have to consider are the standard treatments,” Finn said.
For example, in one of the trials run by Madajewicz, a new combination of drugs to treat advanced colorectal cancer is being evaluated against the treatment that has been the standard for several years. Once the safe dosage levels have been determined in phase one, the trial moves to phase two, where the efficacy of the new treatment is studied.
“Our goal in this particular trial is that we get at least a 15 percent better result than is seen with the standard treatment and that we can significantly prolong a patient’s survival,” said Madajewicz.
Of course, trials are not only about cancer, and they are not only about treatment. They are done for a variety of medical issues, for alternative or complementary medicine, and for prevention.
Patricia Hentschel is a nurse practitioner and project director at the Stony Brook branch of STAR, a nationwide study of more than 20,000 women to compare the benefits of tamoxifen and raloxifene in the prevention of breast cancer in women who are at high risk.
She said when a trial is done under intensive scientific scrutiny and when the patient does her job of being informed, there can be a happy confluence of medical technology, help for the individual participant, and better treatments for those who come after.
Once patients have participated in a trial, “They know there’s always more options. Many will say, ‘What do you have for me next?'” Hentschel said. “They know they will be followed by a research team who is watc