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NPR在线收听:Advice From Patients On A Study's Design Makes For Better Science

发表时间:2017-02-26内容来源:VOA英语学习网
AUDIE CORNISH, HOST: Many studies of new drugs simply languish. They don't attract enough patients, and they aren't completed. That slows medical progress. Well, here's a counterexample. So many volunteers signed up for a federally funded trial of unproven cancer treatments that researchers had to put the brakes on it temporarily. NPR's Richard Harris takes a close look at what makes this study so attractive. RICHARD HARRIS, BYLINE: The study is called the NCI-MATCH trial, and as its leader, Robert Comis explains it discards the normal way of classifying cancers based on the organ where they originate. ROBERT COMIS: So instead of thinking of a breast cancer treatment or a lung cancer treatment or colon, it looks at the different mutations that occur in the tumors. HARRIS: The study recruits people who have tried and failed traditional cancer treatments, people like 74-year-old Nancy Nahmias. NANCY NAHMIAS: It all started actually when I was diagnosed with the cancer of the liver. I was put on chemo, which I reacted very poorly to, and I spent six weeks in the hospital. HARRIS: Her daughter, a physician, learned about the NCI-MATCH trial and encouraged her to give it a try. Scientists screened the genetic pattern of her tumor and found a mutation that might be amenable to a treatment not usually given to liver cancer patients. Nahmias signed up about two months ago at Thomas Jefferson University, one of the many sites running the study. It's too early to say whether it's working, but it's not hurting. NAHMIAS: No side effects whatsoever. I get tired very easily, but that was before I started taking this drug. HARRIS: The MATCH study recruited patients at a record pace. In its first three months, it had enrolled 800 patients, far more than the 150 the researchers had expected. They paused the study briefly to catch up with the lab work. That rapid clip is no doubt because the study is aimed at people like Nancy Nahmias who are running out of traditional options. But it's also because the people who designed the study stopped to ask what would appeal to potential participants. Nancy Roach, a longtime patient advocate, got involved with the medical researchers planning the study early on. NANCY ROACH: This is going to sound goofy, but my dad was in advertising. So you know the Scrubbing Bubbles, the Dow Scrubbing Bubbles? That was my dad, right? So I grew up watching commercials and thinking about what consumers wanted. HARRIS: She brought that sensibility to the conferences where the NCI-MATCH trial was being planned. Dr. Peter O'Dwyer, who was in on those conversations, recalls that the original design would have split patients who seemed to be doing well into two groups. PETER O'DWYER: And in one, continue the treatment, and in the other group, take them off the treatment for what was called a drug holiday. HARRIS: Roach remembers her immediate reaction to that design. ROACH: Taking a patient who's responding to treatment, taking them off treatment - that is not going to fly. HARRIS: She correctly anticipated how patients like Nancy Nahmias would have reacted as they thought about whether to sign up for the trial. NAHMIAS: I would not have liked that. HARRIS: Why so? NAHMIAS: I mean if it seems to be working, let's face it; I don't want to do anything to sabotage myself. O'DWYER: The design had certain attractions, but it clearly had certain flaws. HARRIS: O'Dwyer says on the one hand, the drug holiday would help doctors tell whether a tumor was just growing slowly or actually responding to treatment. But on the other hand, they heard the argument from Nancy Roach and others in the patient advisory group. O'DWYER: We all agreed and changed the design of the study accordingly. HARRIS: So how do you get that information without having the so-called drug holiday then? O'DWYER: You don't. HARRIS: That would come out in a follow-up study. Comis says time was when researchers designed studies without any patient input back in the days when patients tended not to question their physicians to begin with. But as patients have gotten more involved in their own care, so too have their advocates become more involved in the technical discussions of study design. COMIS: That has increasingly become the norm in the development of clinical trials. HARRIS: Comis and O'Dwyer work together in Philadelphia at the ECOG-ACRIN Cancer Research Group. Years ago, Comis was involved in a landmark study which put patient cooperation to the test. Back in the 1990s, doctors were increasingly encouraging breast cancer patients to undergo very aggressive treatment involving bone marrow transplants. That advice was based on poor evidence, so Comis wanted to run a rigorous trial to see if that really worked. COMIS: And we struggled throughout the '90s to put enough patients on clinical trials, which ultimately showed that it didn't work. HARRIS: Comis recalls that patients and their advocates as well as doctors really didn't want to question the prevailing wisdom about bone marrow transplants. COMIS: And I think that one of the reasons that some of those early trials took so long was because the whole external environment was against participation in these particular trials. HARRIS: That experience validated his view that patient advocates are central to doing good research. From Nancy Roach's perspective, it takes a bit of nerve to speak up in a room of doctors and scientists and ask basic questions like, will the results of this study actually help anybody? ROACH: And that's what I do. I'm not a scientist. I'm not a clinician. I'm there on behalf of patients. HARRIS: Her own journey started when her mother-in-law developed colorectal cancer. Roach went from being an advocate for one patient to an advocate for many. And while she's gratified to see that more and more people are stepping into that role, she notes that most are white and economically advantaged. ROACH: Honestly, most of them look like me, and that's a problem, you know? That's really a problem. HARRIS: African-Americans are underrepresented in clinical trials. That may be because their doctors aren't so likely to suggest them, or it may be that the trials aren't attuned to their particular needs. Roach hopes this will be the next frontier for patient involvement. Richard Harris, NPR News. 来自:VOA英语网 文章地址: http://www.tingvoa.com/17/02/Advice-From-Patients-On-A-Studys-Design-Makes-For-Better-Sci.html