Blogs

In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft a lay or plain-language summary for phase 2-4 clinical trials. These lay summaries need to be published to the new portal that will be hosted by the European Medicines Agency (EMA) within 12 months from the close of each clinical trial. “Any sponsor with a clinical study that is set to complete after July 2019 will need to be in compliance,” said Kasim McLain, Manager, Disclosure Services at MMS, and former Manager, Clinical Disclosure Lead at GlaxoSmithKline. “With ...
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DIA 2018 is fast approaching and by now you likely have at least taken a quick look at the program offerings. I’m writing to encourage you to take a second or even third look at Track 5, Patient Engagement (PE). Successful clinical trials depends on true engagement with patients and advocacy communities, and the sessions offered through Track 5 address many of the obstacles you may face in your design and recruitment strategies. If you’re new to this area, you might consider the session on Patient Observation vs Patient Engagement. Industry leaders will share how they use patient advisory panels to fine tune their needs, while advocates will talk about their ...
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We are all looking for the special gift that means more, and there is no better way to do that than to purchase gifts from non-profit organizations.  Many groups use holiday gift giving for special fundraising opportunities, including members of the DIA Patient Engagement Community . It’s our pleasure to recognize these gifting opportunities here on the DIA blog.  We hope if you have a project in time for the holidays, you will add it to this blog post where DIA members can find that special gift. Kicking off this list is a project I know well – Something On Our Minds, Volume 4 .  This is an anthology of Multiple Sclerosis writings from 25 advocates who ...
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I am friends with the author of this blog, Carolyn Thomas, and with her permission I am copying it in its entirety here  but I encourage you to share the link to her post with the people who make decisions on including patients in conferences.    https://myheartsisters.org/2016/03/06/my-open-letter-to-patients-included-conferences/ You will also have to go to her site to get the original formatting and possibly to follow the many links she has included.   best, Laura Dear medical conference organizers, Thank you so much for inviting me to participate in your conference later this year. It is a real honour to be asked to help represent  the patient ...
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We all know that patient engagement is essential. Take the Pledge to patients – a commitment to more meaningful patient engagement in medicines development - and make it happen!,  Are YOU ready to commit? Sign your pledge right now at www.patientfocusedmedicine.org They have signed their pledge and set personal objectives for better patient engageme
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The FDA established a public docket to solicit input on ongoing efforts to enhance mechanisms for Patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. This concept was directly informed by the public feedback solicited through the prior public docket regarding FDA's stakeholder engagement responsibilities outlined by the Food and Drug Administration ...
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On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the opportunity for a much needed final adjudication of the parameters of commercially confidential information within clinical trial data. [1] Background To recap briefly on the facts of this case, PTC Therapeutics obtained a conditional orphan marketing authorisation (“ MA ”) for Translarna for the treatment of muscular dystrophy. Translarna was granted a conditional MA in May 2014 as an orphan product. Following the grant of this conditional MA, in October 2015 the EMA received an access to documents request pursuant to Regulation 1049/2001/EC (the ...
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Just when I thought the patient experience and our voice was being considered and respected as a serious partner to the drug industry, I get that reality call to take off the rose colored glasses. This time the splash of cold water to bring me back to my senses came via a tweet from a respected person in the patient advocacy field.This person had received an electronic newsletter from Clinical Leader, a group that states they are the "premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers." and when the headline ' The Anatomy of the Ideal Clinical Trial Participant' was selected, ...
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Like every other Project Manager I know, I have a thousand demands on my time. Why do I choose to be a part of the DIA Project Management Community? I got involved in DIA back in 2008, as a session chair at the Annual Meeting. I was looking for opportunities to present on PM topics, and DIA seemed like the ideal meeting to meet other professionals who worked in the pharmaceutical industry. The meeting exceeded my expectations - so much to see and learn, and so many experienced people to meet and network with - and I was bitten by the Annual Meeting 'bug'. I really enjoyed presenting, talking with other PMs who faced similar challenges in ...
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Global Project Management Colleagues: It's already March and about 3-1/2 months from this year's DIA Annual Meeting in Philadelphia (June 26-30). I hope as many of you are planning to attend as possible! This year's program will offer some new opportunities for learning, networking, as well as feature a very strong Project/Portfolio Management track. Here are a few highlights: 1. The Project/Portfolio Management track will offer sessions in drug development from different therapeutic areas, maximizing the value of your product, decision-making, expanded access, CMC, international price referencing and leadership. 2. The addition of multiple plenary ...
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by Peter J. Pitts Reposted from the DIA Collaborate to Innovate Blog The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides. And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not DTC tactics. Not managed market negotiations – the responsible sharing of truthful and accurate information. It’s important to say early in the conversation that ...
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A recent article by Shashi Amur and FDA colleagues on the future of biomarker development ( Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization — http://onlinelibrary.wiley.com/doi/10.1002/cpt.136/abstract ) provides a solid foundation for ongoing development and review process for biomarker qualification. FDA should be applauded for their progress in agency collaboration with the Critical Path Institute (in biomarker consortia development), the recent total kidney volume and plasma fibrinogen prognostic marker approvals, and sponsorship of interactive sessions such as the recent ...
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