Operational Engagement With Patient Advocates

    Operational Engagement With Patient Advocates January 21, 2020 [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep154_operational-engagement-with-patient-advocates.mp3" title="Operational Engagement With Patient Advocates" color="#FF5722" social_linkedin="true" social_email="true" tweet_text="Check out this podcast on operational engagement with patient advocates!" hashtag="InformedConsent, ClinicalTrials" twitter_username="darshantalks" ] [learn_more caption="Read Transcript"] Darshan: Hello everyone. Welcome to another episode of Darshan Talks. We have Trishna Bharadia with us again and I'm really excited because we had a whole conversation pretty recently around the practical considerations of being a patient advocate, and how people want to engage with patient advocates, what make it really difficult. Darshan: But one of the things Trishna mentioned in the last conversation is the problems around informed consent and how they've gotten ridiculous to be quite honest. And a part of me as a lawyer believes that, that's completely legitimate because we're trying to protect the company. Darshan: But then there's the practical element of this. So Trishna, if you could introduce yourself and then sort of go off on what are some of the issues with informed consent and what might be some solutions if you will. Intro: This is the Darshan Talks podcast, regulatory guy, irregular podcast with host, Darshan Kulkarni. You can find the show on twitter @DarshanTalks or the show's website at darshantalks.com. Trishna: My name is Trishna Bharadia, I'm from the UK and I'm a health advocate and patient engagement champion. So I work to get the patient voice heard louder, stronger and more effectively within the entire healthcare journey. And so in terms of particularly informed consent and patient information, leaflets when it comes to participating in clinical trials and research studies. Trishna: So for me it's very much... I mean to be honest, they're too long, they're too complex, the language that is used is far too complicated. And I take the attitude, yes, we need to have the legal protection, not just thought the sponsor, but for the patient as well. Trishna: But at the end of the day, if a patient doesn't understand what they're signing and doesn't understand the information being conveyed to them, then that document isn't fit for purpose. So an example I was recently sent two patient information leaflets and informed consent forms for clinical trials that somebody that I know who lives with inflammatory bowel disease, that they had been sent by their doctor because at the moment there is two clinical trials that could potentially be a way forward for their own treatment. Trishna: And they sent me these documents and say, "Could you have a read of them. I know you're a health advocate and your obviously used to reading these documents and just let me know what you think." Now for each study there was 30 plus pages to read through. The language was not patient friendly at all and the entire document was just, it was very complex. Trishna: There was a lot of text in there so it looked completely overwhelming. And one of the studies in particular within the study itself, there was multiple branches, there was lots of sub studies going on within this clinical trial. And I came away from reading those two documents, well over 60 pages worth of information and I didn't feel informed. Trishna: I didn't really understand what the trials were, what was involved in them and what the patient commitment would be. And to be a perfectly honest, they gave me a bit of a headache because languag...