Study participants are being recruited through Internet advertisements and directed to the study’s website, which explains the study and allows enrollment.
Patients who enroll in the study will be required to have blood drawn at a local clinic or during a home visit. Medications will be mailed to participants, something that’s rarely, if ever done in clinical trials. Patients will keep diaries using a mobile phone that has an application specifically designed to track symptoms of overactive bladder. Patients will fill out assessments on a secure website four times throughout the study.
A single study site medical team at UCSF will monitor the trial, which will replicate the original trial done for the drug, which is already FDA-approved
I could not find a copy of the study protocol or informed consent, so what follows is just my take from the study website…
From what I can tell, there will be no face to face contact with study subjects prior to enrollment, and I suppose, no physical examinations, except for subjects in California. I wonder how much work is going to be required of the patient’s own physician – release of records, physical exam, review of the study and approval of patient’s enrollment? And isn’t sending study drug to patients sort of like prescribing medication over the internet without the benefit of a doctor-patient relationship? Just asking – I’m no lawyer, but in general we tend to frown on this sort of thing in the medical circles I travel in…
Head on over to the study website yourself and check it out. The study info video is more like a sales pitch than anything else, with a little cash registers ca-chinking noise every time a study survey is completed, and lots of fun cartoony things explaining the study logistics, making the whole thing look like a real blast and a fun way to make a little extra cash. Only at the very end of the three minute video do they tell you that you may end up getting placebo, and there is nothing of course, about the DRUG you’ll be taking, or it’s possible risks. To get that info, you’ll have to register, and live in a state where the study is being conducted. (I know because I tried to get a look at it, but apparently the study is not being done in New York State).
My Take as As an IRB member
I don’t think I would have approved that recruitment video. Too happy and cutesy, with statements like “You’re probably here because you have symptoms of overactive bladder syndrome, and you want to do something about it” – implying treatment rather than research.
The study intro page states the study is about testing the efficacy of Detrol for reducing incontinence, but the video really has little about actually taking a drug, and more about the fun stuff that will happen over the internet. There isn’t even a picture of a person actually taking a drug – everyone seems to be “receiving” a drug, but not “taking” anything. I swear, by the time I finished watching the video, the medication was the last thing I was thinking about.
Other statements that bothered me – “Lucky you – you’ll be getting three packages!” – implying that participating in the study will make you lucky, as opposed to having an adverse effect of the drug being studied (which would be unlucky…).
Then there is the introduction of the concept of informed consent – “Sound intimidating? Don’t worry – it’s easier than it sounds!”. “They’ll be pop quiz at the end” and a cute pic of a teacher and an apple, as if signing the consent is being a good student, while not signing it means you’ve failed. Informed consent is the cornerstone of clinical research, even when it’s a study of a drug that is already FDA-approved. Let’s treat it with the seriousness it deserves.
The video does do a nice job explaining double-blinding, but not randomization, saying “there is a chance you’ll receive either study drug or a sugar pill”, but that’s not a chance, that’s the study. They also leave randomization to the end – I would have put it earlier on in the video, since for many subjects, the chance of getting a placebo is a game changer.
I like that subjects have access to their study results, and, I assume, lab results along the way. Most studies allow this, but not with the kind of ease the internet provides.
Is this the End of the Multi-center Clinical Trial?
Centralizing the study team will no doubt save tons of money, move things along faster without having to clear dozens of institutions’ IRB and contracts offices, and give much desired consistency and control of the study’s conduct. I do find it hard to imagine some of the clinical trials out there being conducted without a local study doc to handle complications, physical exams, etc. So I expect that this model won’t translate very far in its entirely. But I do see this internet-based approach being used to substitute for a lot of what local study coordinators do, freeing up the study doc up to worry about what’s important – the patient.
I do worry, thought, that all this centralization could give too much control of research to a single site. In the case of this study, that site is located at a University which just partnered with Pfizer to the tune of $85 million. I’m not trying to imply anything about this study in particular, just using it as an example to note the potential for conflicts as the relationships between Pharma and Academic Medicine become cozier and cozier. (Pretty much every big center is partnering in a big way with Pharma these days…) Pfizer’s press release states that two institutions IRB’s approved the study, and that made me happy. Given the amounts of money changing hands now between Pharma and Academic Medical Centers, the use of independent IRB’s may become more important over time to avoid any concerns over conflicts in research.
Will Internet-based Research Expand Study Subject Populations?
Despite my reservations about the recruitment video, and the logistics of handling study complications, I think the idea of using the internet to facilitate research is an interesting one, and may expand the population of folks willing to participate in clinical trials. As medicine moves out of the office into the internet and into our patient’s homes, I see no reason why research should not follow. Just so long as we proceed with caution and safeguards.
One final thing
Kelsy, the NP on the the study (see her around 0:25 on the website video), reminds me of Pam from the Office. Uncanny…Especially when she talks. She seems really nice. So does the entire study team. I wish them the best on their project.