Background:The SENSCIS® trial (2015–18) was a large clinical trial (n=576) investigating the efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease.1 The clinical research sponsors (CRS) collaborated with the scleroderma patient community advisory board (CAB) regarding the design, implementation and conduct of the trial.2 As part of this collaboration, the CRS and CAB developed a post-trial survey for SENSCIS® participants. The use of the developed patient-centric materials was optional for the sites.Objectives:The objectives of the SENSCIS® post-trial survey were to gain experience in collecting real-world information and trial satisfaction data from patients to inform and improve future patient centric clinical research.Methods:SENSCIS® trial participants who were involved in the extension trial SENSCIS®-ON completed a post-trial survey covering nine multiple-choice questions about three main topics:[1]Recruitment – Where do patients usually search for clinical trials and how did they become aware of SENSCIS®?[2]Motivation & Retention – What motivated patients to start and continue participation in SENSCIS®?[3]Challenges & Wishes – What were the challenges during trial participation and how can future clinical trials be improved regarding patient centricity?Results:A total of 125 participants completed all survey questions. Participants could select more than one option. A total of 51 patients reported that they are usually not actively looking for trials. For those actively searching, the most common sources to learn about trials were specialists/general practitioners (GPs) (46 patients) and internet search engines (20 patients), followed by patient organisations (12 patients). Of note, 78 patients would pay attention to printed materials, such as a card/flyer/poster in a doctor’s office and get in touch with a trial/study site.Back in 2015–2017, during recruitment for the SENSCIS® trial, the majority of the patients who answered the survey were made aware via their specialist/GP (116 patients), whereas 5 were made aware via patient organisations and 4 via the internet.The most frequent motivations to join the trial were ‘hope to receive an improved therapy’ (98 patients), to help other patients (64 patients), and on the recommendation of their specialist/GP (81 patients). Similarly, the most liked aspects of the trial were the ‘opportunity to receive an improved therapy’ (92 patients) and ‘to support the development of an improved therapy for my illness’ (90 patients). More than half of patients reported ‘continuous observation of general health’ (72 patients) and ‘advice from GPs/specialists’ (71 patients) as motivation to stay in the trial (Figure 1).‘Concerns about side effects’ (72 patients) and ‘not knowing whether the trial medication will work for me’ (63 patients) were reported as the least liked aspects of the trial. Travel to the site was reported as a challenge by 21 patients.To improve clinical trials, patients requested more patient-friendly information (50 patients) and multiple formats of information material (46 patients). Finally, 48 patients expressed the desire to communicate with other trial participants.Conclusion:The SENSCIS® post-trial survey is a unique approach to receive real-world feedback from trial participants, and these pilot data will help improve future clinical trials and communication. The results highlight the importance of reaching patients who may not be actively looking for clinical trials.Figure 1.Motivation to stay in the SENSCIS® trial1,21More than one option could be selected.2Data collected on 9th January 2021References:[1]Distler O et al. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076.[2]Roennow A et al. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.Acknowledgements:Sue Farrington (Federation of European Scleroderma Associations [FESCA] Belgium), Luke Evnin (Scleroderma Research Foundation, United States), Beatriz Garcia (Asociacion Espanola de Esclerodermia, Spain), Catarina Leite (Associacao Portuguesa de Doentes com Esclerodermia, Portugal), Alison Zheng (Chinese Organisation for Scleroderma), Matea Perković Popović (Hrvatska udruga oboljelih od sklerodermije, Croatia), Tina Ampudia (Asociacion Mexicana de Orientacion Apoyo y Lucha Contra la Esclerodermia, AC, Mexico), Stephanie Munoz (Norsk Revmatikerforbund, Diagnosegruppen for Systemisk Sklerose, Norway), Monica Holmner (Reumatikerförbundet Riksföreningen för systemisk skleros, Sweden).Disclosure of Interests:Ilaria Galetti: None declared, EDITH BROWN: None declared, Ann Kennedy Consultant of: I have been a member of the CAB (Community Patient Advisory Board) described in the accompanying abstract under discussion. My patient organisation has been paid for its participation in the CAB., Grant/research support from: It is not myself personally, but FESCA (Federation of European Scleroderma Associations) aisbl., that has received project grants for awareness raising and education. I was President of this Federation., Robert J Riggs: None declared, Annelise Roennow: None declared, Maureen Sauvé: None declared, Joep Welling Speakers bureau: BI MIDI and BI International, Sanofi, Henrik Finnern Employee of: I am employee of Boehringer Ingelheim International GmbH, Annie Gilbert Consultant of: I am a paid consultant for Bohringer Ingelheim since 2016, Martina Gahlemann Employee of: I am employed by Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland, Wiebke Sauter Employee of: I am employer of Boehringer-Ingelheim
Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic
