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Decentralized Clinical Trials and Patient Needs

Trishna Bharadia discusses the evolution of decentralized clinical trials with Parexel’s Rosamund Round, Vice President, Patient Innovation Center and Amanda Knaggs, Senior Recruitment and Alliance Site Manager. Trishna shares her daily living experience managing multiple sclerosis, and the impact virtual trials would have on her ability and willingness to participate in a clinical study. Whatever challenges the world may throw at us — now, and tomorrow, Parexel’s Decentralized Clinical Trials represent an opportunity to rethink the traditional clinical trial model and refresh how research studies are conducted, while keeping the patient at the heart of this emerging paradigm. Developed within our Patient Innovation Center, our flexible Decentralized Clinical Trials solutions provide both fully virtual trials and hybrid options. Trishna Bharadia (00:01): I lead a really busy life. I work as a translator and analyst for a business intelligence company. And on top of that, I'm managing my MS, I'm managing the other conditions that I live with. To have taken part in the trials that I have been offered, it would've involved basically too much travel, too much time, too much burden on my family because I rely very heavily on my parents, particularly if I need to be taken to places. There's no point in taking part in something which is then potentially going to make you feel exhausted, or it's going to have a burden on your finances. Rosamund Round (00:47): And I think that's one of the things that makes it so exciting working in the area of decentralized trials is that both we ask patients what they want and we can use technology to make patients lives easier. Things like sensors, for example, where patients don't have to actively go and have a test, they just wear a watch for example, an actigraphy device, or we can use video calls with site stuff so you don't have to spend all that time traveling. Amanda Knaggs (01:09): Decentralized trials, I think will really help to improve the patient recruitment. And most importantly as well, the retention of the patients that enroll onto studies. Trishna Bharadia (01:20): You've raised a really good point there because it's one thing getting somebody to take part in a trial in the first place but it's something completely different to keep them in the trial. Amanda Knaggs (01:30): It's a partnership between the medical research organizations and the patients themselves. Trishna Bharadia (01:36): From my understanding there can be trials where everything is very virtual and technological but then there's others, which aren't so much. Is it possible to have a mixture of the two or does it have to be one or the other? Rosamund Round (01:50): There's basically a spectrum along how virtual you want to make a trial. So traditional is obviously at one end. Fully virtual or fully decentralized is at the other end. And that's when the patient never even pops a toe into a site. Everything's done for them in the home. And then you've got different shades in between. And we take a look at what physically has to be done at the site. So an MRI scan or a lumbar puncture needs to be done at site. Some of the simpler things can be done at home. So questionnaires and blood draws, that kind of thing, the patient doesn't need to come into the site for it. Amanda Knaggs (02:20): So I think the site staff are really keen to learn and and adopt these technologies because the accuracy of the data that is captured is much better now than in the past. Rosamund Round (02:32): I know you've said that fitting a traditional clinical trial into your life could be quite challenging, but if some of that could be done in the home, do you think that that would enable you to maybe take part in a trial? Trishna Bharadia (02:43): Definitely. Definitely. Because I could just say, "Okay, you know the nurse is going to come at 10 o'clock." I could say to my boss, "Okay between 10 and 10:15, you won't see me online." And it would mean that I could spend more time with my parents in a way that isn't just about the caring aspect. It's about allowing me and my family to live our lives the way we want to live them. Learn more about Parexel’s Decentralized Clinical Trials Solution: https://www.parexel.com/solutions/clinical-development-services/decentralized-clinical-trials Contact Parexel at: https://www.parexel.com/company/contact-us Listen to the Parexel Podcast: https://www.parexel.com/news-events-resources/blog/podcasts Facebook: https://www.facebook.com/parexel LinkedIn: https://www.linkedin.com/company/parexel