DECENTRALISED CLINICAL TRIALS AND THE FUTURE
with at least six newly initiated trials in women’s health harnessing them each year since 2017, our analysis shows. AbbVie and Myovant Sciences, for instance,
have both used eDiaries in more than half of their women’s health trials in the past decade. A large share of AbbVie’s research in women’s health has focused on endometriosis.
Privacy a key reason for high eDiary uptake The discreet nature and convenience of eDiaries make them ideal for collecting sensitive information in women’s health trials where a lot of pain or symptom reporting is needed, says eClinical solutions chief
post-menopausal women having as many as 50 hot flashes a day were compliant in a trial with eDiaries, recording each incidence. The alternative is recording high volumes and often sensitive information on paper, which can open up privacy issues within a household, she adds. higher reporting among participants due to measured arousal levels and satisfaction after sexual encounters in a female sexual dysfunction study. imperative in these trials: “A lot more data was reported electronically because it was private.” If patients had to visit their doctor to discuss every sexual encounter, they would not have collected the same quality data, she adds. Further, eDiaries can curb “parking lot
syndrome”, a well-known occurrence in patient-reported outcomes. This refers to patients completing diaries and questionnaires shortly before a visit, when they should have are manifesting. With eDiaries, questionnaires are deployed “Capturing that data in real time without recall bias is much more exact.”
Social media: a channel for women’s health recruitment DCTs are designed to help break down access barriers, and this can allow women
92 | Outsourcing in Clinical Trials Handbook
“The discreet nature and convenience of eDiaries make them ideal for collecting sensitive information where a lot of pain or symptom reporting is needed”
to participate in clinical trials from their own homes without too much disruption to daily life. Yet, another barrier is the lack of general
awareness that these trials are happening, Maini says. And this is where social media could potentially help with recruitment. methods to communicate and lots that are talking about women’s health,” she adds.
embarrassing to discuss with their doctor, being able to advertise a fully virtual trial via social media dramatically sped up the recruitment timeline to 3.5 months, and reduced recruitment costs. ObvioHealth studied the online search and purchasing behaviours of women scouring the web for products or solutions for pelvic floor disorder. “Then we placed our creative ads in front of those women via social media like Instagram, Twitter, and Facebook,” Culbreth- The decentralised trial design proved
attractive to female incontinence sufferers as they could participate privately and discretely Arena previously reported on the advantages of social media recruitment, and potential blind spots for sponsors. While positive trends can be observed in
decentralising women’s health trials, there is room for growth. This can be supported by further technology advancement and stakeholders becoming even more accustomed to decentralisation. “DCTs are becoming more prevalent and it’s our job to educate the world says. “Then we will see more DCT trials in women’s health.”
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