DIVERSITY, EQUALITY & INCLUSION


As the use of decentralisation has grown, eDiaries have become even more common, with at least six newly initiated trials in women’s health harnessing them each year since 2017. 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 has focused on endometriosis.


Privacy is a key reason for high eDiary uptake The discreet nature and convenience of eDiaries makes 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 mareting officer heila occhio. As an eample, occhio says even post menopausal women who were having as many as 50 hot flashes a day were compliant in a trial using eDiaries, recording each incidence. The alternative is recording high volumes and often sensitive information on paper, which can open up privacy issues within the household, she adds. esearch also shows that eiaries lead to


higher reporting among participants due to privacy, occhio notes, pointing to trials that measured arousal levels and satisfaction after sexual encounters in a female sexual dysfunction study. She explains that eDiaries were imperative in these trials: “A lot more data was reported electronically because it was private.”


The challenge of collecting quality data 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”, which is a well-known occurrence in patient-reported outcomes. This refers to patients completing diaries and questionnaires shortly before a visit, whereas they should have been filled ot daily or when specific symptoms were manifesting. With eDiaries, questionnaires are deployed when they are spposed to be filled and notifications can be sent, says lbrethotaro. “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 to participate in clinical trials from their own homes without too much disruption to their 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. “Now there are so many more platforms and methods to communicate, and lots that are talking about women’s health,” she adds. Culbreth-Notaro says that for an indication sch as incontinence, which many women find too embarrassing to discuss with their doctor, being able to advertise a fully virtual trial via social media dramatically can speed up the recruitment timeline to 3.5 months and reduce costs. ObvioHealth studied the online search and


purchasing behaviour of women scouring the web for products or solutions for pelvic floor disorders. “Then we placed our creative ads in front of those women via social media, like Instagram, Twitter and Facebook,” says Culbreth-Notaro.


Private and discrete The decentralised trial design proved attractive to female incontinence sufferers as they could participate privately and discretely from their own homes, she says. Clinical Trials 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 on what that model brings,” says Culbreth-Notaro. “Then we will see more DCT trials in women’s health.”


Outsourcing In Clinical Trials | 61


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72