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It Should Be All About the Patients

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The end of June saw the start of summer and the DIA Annual Meeting in Philadelphia. I had planned on blogging from the conference itself, but in all honesty I've been struggling to decide what to write about. So, here are my thoughts on a couple of sessions I was lucky enough to present in. The start of DIA saw a press release from Medidata about an exciting new study conducted by Tufts Center for the Study of Drug Development (CSDD) on the amount of potentially unnecessary procedures in clinical trials. Some of the initial data was presented at the conference by Tufts CSDD’s senior research fellow Ken Getz. While I don't think we actually said that 25% of procedures in a clinical trial are pointless, you can read more in an Outsourcing-Pharma interview I did. You'll be hearing much more about this study in the coming months as the detailed results of the study are published, and I know it will stimulate a huge amount of discussion. The basic principles of designing a study should dictate that you only include procedures that are needed to meet the study's objectives. But from the work we do here and the results of this study, it is clear that isn't the case! I've blogged before about the importance of this, and about how I believe that the missing piece of the puzzle is visibility into the impact of decisions that are being made about study design. But what really hit me as I sat listening to Ken at DIA was that, at the end of the day, every procedure that is conducted is conducted on a person—in many cases a sick patient who has enough to deal with without us poking and prodding them unnecessarily! My reflection on life as a participant in a clinical trial continued when I stepped in for my colleague, Sondra Pepe, as chair of a session on the impact and use of standard of care in planning and budgeting for trials. I am not hugely familiar with the US health care system—as a Brit who has only been in the US for three years and has thankfully not had to interact with the health care system much in that time!—and so as I researched the topic in the two days before the session, I was frankly stunned by what I learned. The complexity of being a participant in a clinical trial, the potential financial burden on the patient and the burden on the site/sponsor that comes with the multitude of rules and regulations (of course, all of which vary by insurer and state!) made me wonder why anyone, patient or site, would participate in clinical research! It also highlighted the need for the industry to work closely with sites and experts in the field of standard of care to provide materials and information that ensures participants understand what they are consenting to and the potential financial liability. I also learned a lot about misrepresentation in the media of how clinical research works. I'm hoping that Sondra will blog with me more on these topics soon! So, my takeaway from the conference is that in everything we do as an industry, we should remember that there are real people impacted by every decision we make—medical professionals and patients who could have a great experience and be the future of clinical research or could have a horrible time and walk away, making it even harder to recruit good patients and sites. If you would like to learn more, join Michelle Marlborough and Ken Getz from Tufts CSDD for an upcoming webinar on study design and protocol development, to hear more about the new Tufts study research findings. Additional blog posts by Michelle Marlborough: Data, Data Everywhere… How Can We Accelerate Innovation with Standardization? Thoughts from the CDISC European Interchange Different Conference… Same Issues? TREND 10: Increased Demand for Technology to Support Overall Clinical Development Planning TREND 7: Protocol Design Will Triumph Over the Document More about Michelle Marlborough

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