用例：以患者为中心的临床试验地点选择方法

Tyagi N1, Aasaithambi S1, Chauhan J1, George AT1, Zaour N21Novartis Healthcare Pvt. Ltd., Hyderabad, India;2Novartis Pharma AG, Basel, Switzerland BACKGROUND Diagnosis of IgAN •Diagnosis usually happened at 21–30 years of age, mainly through biopsy. Patients and caregivers have shared theirexperiences with diagnosis process on social media. –One of the unmet needs at the time of diagnosis was the absence of detailed disease-related information andcounselling post- diagnosis, causing emotional stress on patients/caregivers. •IgAN or Berger’s disease is a rare autoimmune renal disease characterised by the presence of predominant IgA1deposits in the glomerular mesangium,(1)with the peak incidence observed in young adults aged 20–30 years.(2,3)•IgAN patients are heterogeneous as their clinical presentations and rate of progression to end-stage renal disease(ESRD) vary. Some of the common clinical symptoms mentioned in literature are the presence of proteinuria andhaematuria.(4)•There is scarcity of published evidence on the humanistic burden of IgAN. In this new ‘digital age’, the use of socialmedia and analysis of posts can be an innovative way to capture patients insights and understand the burdenassociated with this renal disease from a patient’s perspective. Disease Management •Patients/caregivers mentioned on social media that initial treatments were with anti-hypertensives followed by oralcorticosteroids and/or immunosuppressants. –Patients/caregivers often used social media to find from other patients if the current standard of care could lowerurine protein content, reduce hypertension and prevent progression of disease.–The need for a curative and safe treatment was highlighted in patient conversations given the lack of efficacioustherapies and the side-effects of corticosteroids.–Additionally, patients/caregivers were of the opinion that diet management could control disease progression andenquired on social media if there was any particular diet that could manage IgAN progression as they felt that notmuch information was obtained from their healthcare providers on this topic. OBJECTIVE •The objective of this study was to explore the patient journey, quality of life (QoL) and unmet needs from the patients’perspective through social media listening (SML). METHODS •This retrospective SML study gathered data from open sources such as Twitter, Blogs/Media, Patient Forums,Facebook and Newswires from February 2017–September 2018.•A search strategy was developed using Medical Subject Heading (MeSH) terms for IgAN and a social media dataaggregator tool (SalesForce Social Studio®) was used to download social media posts.•The downloaded data was anonymized to remove all personal identifiers and categorized for analysis, based onchannels, stakeholders, sentiments and key themes of discussion.•Post data anonymization; data curation, analysis and insights generation was carried out using primarily human interventionsthat was partly supported by machine learning interventions such as NLP (Natural Language Processing) algorithms.•Discussions in English language specific to IgAN originating from the US and the UK were included in the analysis. Disease Progression •Approximately 30% of patients discussed progressing to ESRD within 7–12 years, requiring dialysis and few patientsalso mentioned need for renal transplant, adding to the disease burden.•Patients perceived that once the disease has progressed to ESRD, there was difficulty in getting the right donor forrenal transplant and they also understood that there was a risk of disease recurrence post-transplant. Impact of IgAN on Patients’ QoL •Restricted physical activity due to symptoms such as fatigue and pain combined with emotional aspects such as fearof disease progression, anxiety, depression and regular dialysis requirement affected the QoL which are illustrated bythe patient/caregiver verbatim (Figure 5). RESULTS •A total of 1,336 relevant posts (mix of posts from both patients and caregivers) were included for analysis, of which87% originated from the US while the remaining posts were from the UK (Figure 1A). •Twitter was the primary source of information, contributing to 49% of total posts followed by other sources such asPatient Forums (40%), Blogs/Media (6%), News (4%) and Facebook (1%) (Figure 1B). •Additionally, female patients were fearful that their condition could result in “preeclampsia” in pregnancyFigure 5. Impact of IgAN on Patients’ QoL Figure 1. Percentage Split of Posts by Geographies and Data Sources (N=1,336) •The key discussions from patients and caregivers were mainly focused on seeking or sharing advice, information, andexperiences on IgAN symptoms, diagnosis, treatment options and current disease management Patient Journey and the Perspectives on IgAN •The analysis provided key insights into the patient journey as described by the patients. The patient journey illustratedbelow was developed based on the patient/car