Integrity of blind trials faces complications in hashtag era
People use social media to share their stovetop exploits, their jogging routes and their reading habits.
In the area of double-blind clinical trials for pharmaceutical drugs, the instantaneous communication available through Facebook, Twitter, Instagram and other platforms carries with it the risk of lifting the veil purposefully put in place by researchers, according to a patient advocate and professionals in the pharmaceutical field.
In double-blind trials, neither the participants nor the researcher knows who is receiving a placebo and who is receiving the actual drug.
"Things are getting more and more complicated in this area with the growth of social media. Patients are in contact all the time," said Tracy Seckler, of Charley's Fund, a Great-Barrington-based organization aiming to further the development of treatments for Duchenne muscular dystrophy.
Speaking on a Rare Disease Day panel at the State House, Seckler said rather than pretending information-sharing doesn't exist between patients on blind trials, the medical research community should "face it head on and find ways to deal with it."
"I don't think we should fool ourselves about the integrity of a blind, for example, when maybe it's clear from day four that there's a side effect," said Seckler, whose son has participated in a clinical trial but not a blind clinical trial. "Just speaking from the patients' perspective, we're all telling each other, 'I know I'm on placebo,' or 'I know I'm on drugs.'"
Dr. Gilmore O'Neill, senior vice president of late stage clinical development at Cambridge-based Biogen, said patients have been guessing at whether they are on a placebo or the real drug since before the advent of social media sites.
"You can never be sure. You may imagine or think you know. But you can't be absolutely certain," O'Neill told the News Service. "Nevertheless it could potentially cause a problem because basically people could start drawing inferences, and it could alter behaviors and have the potential to introduce bias."
Organized by the Massachusetts Biotechnology Council, an industry group, Rare Disease Day seeks to bring attention to some of the thousands of ailments affecting only a fraction of the population, and the efforts to discover treatments for them. Patient advocates often seek out one another to collaborate on fundraising for research and network.
"The active patients who are involved in clinical trials, a lot of us know each other. A lot of us talk to each other. So they'll say to each other, 'Hey, when you got your injection, did you have a red rash at the site?' And then all of a sudden, 10 of the 20 are like, 'Yeah, I had a red rash,'" Seckler told the News Service. She said, "So all of a sudden everybody knows."
O'Neill said advocacy groups can be helpful in collecting information about a disease as long as the information is reliable. He said the integrity of clinical trials is paramount, and "in the old days" researchers would try to make sure study participants were not grouped together in great numbers in a waiting room.
"The real thing we have to make sure about the clinical trials is that there is no possibility of compromising the integrity of the data," O'Neill said on the panel. "In other words the key thing is that however the study is done, we do not want to cast any doubt on the effective blinding of the study or introduce any bias."
Sarah Lieber, the head of the Rare Disease Therapeutic Area in Global Regulatory Affairs for Cambridge-based Sanofi Genzyme, said while she has not personally experienced a trial compromised by patients' social media, there is a risk.
"If somebody tweets about side-effects they experience at trial, that might impact another patient," Lieber told the News Service. Lieber said there are firewalls established within blind trials and efforts to educate patients about the trials through patient advocacy groups.
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