Online clinical trial recruitment study assesses patient reliability

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One of the biggest hurdles in advancing online patient recruitment is this — can potential patient participants be relied upon to provide accurate information? And can recruitment efforts skip over physician sites, go directly to patients and still be successful? One study from Quintiles’ digital patient unit suggests they can.

The study sought to recruit people with gout from its drug monitoring website MediGuard.org. Potential participants were emailed based on their MediGuard profiles including gout in the diagnosis description, according to a report describing the study in the Journal of Medical Internet Research. Interested members clicked on an email link to access study information, consent to participate electronically and screened for eligibility.

Participants in the study filled out electronic release forms agreeing to permit their medical records to be reviewed to confirm the diagnosis of gout reported by the patient.

The study looked at  the validity of patient-reported diagnoses collected through patient-reported outcomes with medical records. It showed that patients can be recruited, screened and enrolled from patient community websites, according to a company statement. The study noted that 37 of 38 medical charts confirmed a patient reported gout diagnosis.

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Elisa Cascade is the global head of Operations for the Digital Patient Unit and the lead author of the Gout study. In an e-mailed response to questions, she said Quintiles currently has more than 30 studies in the field related to online patient recruitment. The Research Triangle Park-based CRO ran a 425-patient study in COPD in the US in which it was able to access 74 percent of patient charts. She noted an ongoing study for rheumatoid arthritis and another poised to start this month that includes multiple autoimmune conditions.

The idea is that recruiting patients for clinical trials directly online could significantly cut the costs of recruitment and of conducting clinical trials for drug development and medical devices. According to the report, recruitment costs as they are now can go as high as $1,300 per completed participant and recruitment delays can account for up to 45 percent of study delays.

Direct patient online recruitment could eliminate site-based costs and reduce the time it takes to recruit patients. Demographic information taken as part of the study showed that participants reflected a diverse range of demographics across age and income brackets. And with Pew research data showing that 74 percent of people in the US use the Internet and 80 percent of them are looking for health information, the numbers suggest the Internet is an ideal place from which to recruit.

Cascade notes that since Pfizer halted its attempt at using social media for clinical trial recruitment earlier this year, pharmaceutical companies are still moving forward in their efforts to better develop initiatives in this area.

“We have seen the emergence of clinical innovation groups within several of the major pharma companies including Pfizer, Janssen, Roche/Genentech, and Lilly to name a few,” Cadcade said in an e-mailed statement in response to questions. “Discussions with these innovation groups suggest they are piloting a number of different innovative approaches to reduce the cost and increase the speed of the clinical development process.”

She pointed out that Pfizer has said it is considering a hybrid approach to online recruitment that could combine in-person visits with direct patient recruitment. It could also use electronic patient reported outcome that could include patients keeping an online diary, answering questions online or contact by phone.

The drive to reduce costs balanced with options that provide the most accurate data mean it’s likely to be some time before the pharmaceutical industry determines the best approach.

“Whether a fully remote clinical trial is the answer or a hybrid design that combines both in-person and remote elements remains to be seen,” Cascade said.

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Stephanie Baum

By Stephanie Baum

Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.
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