Join Us in Paris for DIA’s Flagship European Offerings

Who doesn’t love April in Paris? Join us as, for the first time ever, DIA’s EuroMeeting and Clinical Forum will run in parallel, from April 13-15 in Paris, France.

2015 marks 50 years since the first European pharmaceutical legislation and the founding of the European Directorate for the Quality of Medicines & Health Care. Our DIA EuroMeeting 2015 has organized special sessions honoring both the EMA and the EDQM, including our interactive Regulatory Town Hall Meeting moderated by Fernand Sauer, first Executive Director of the EMA.

How do you feel about social media in clinical research? Come Join the Debate: This House believes that people are unwilling to make their data available anonymously to aid the battle against serious diseases while carelessly sharing personal data through social media will be the subject of the Oxford-style plenary debate that will open our 8th Annual Clinical Forum: Clinical Development Riding the iWave, presented in parallel with our 27th Annual EuroMeeting: Development, Innovation, Access and Patient Safety, April 13-15 in Paris.

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Peggy Hamburg: FDA’s 21st Century Commissioner

By Peter J. Pitts

The FDA is not a monolithic entity. The agency is comprised of over 11,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and beyond.

No one person calls all the shots – but the Commissioner is in charge and sets the tone and direction of the body that regulates more than a quarter of the American economy. A really good commissioner is measured by the impact he continues to have once she has departed. By that measure Peggy Hamburg rates an “A.” Continue reading

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Are All Men Created “Equivalent”?

By Peter J Pitts

Bioequivalence is going mainstream.

Ever since the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded in April of 2010 (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index (NTI) drugs, there’s been a growing focus and understanding on the fact that less variability equals better predictability. Continue reading

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InSites: Multiple IRB Reviews of Multicenter Clinical Trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

On 3 December 2014, the National Institutes of Health (NIH) published a Draft NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research Continue reading

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My Regulatory Grand Tour

By Peter J. Pitts

Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Over the past few months I’ve visited with government health officials in China, the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Russia, Brazil, Columbia, South Africa, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation.

It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs.  Continue reading

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InSites: Accelerated Clinical Trial Agreements

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

Albert Einstein proffered the notion that insanity is doing the same thing over and over again and expecting a different result. Yet all too often when it comes to clinical trial agreements (CTAs), this is how we operate: Hoping to best protect their own interests, sponsors and CROs offer a template CTA with terms and conditions unacceptable to the overwhelming majority of institutions (ie, research hospitals and academic medical centers). To gain the strongest legal protections for themselves, institutions counter with terms and conditions unacceptable to sponsors. Continue reading

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The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times

TIRS Editor-in-Chief Stephen Spielberg recently recorded a podcast with Joseph DiMasi and Kenneth Getz, both from the Tufts Center for the Study of Drug Development. The conversation focused on their paper, published in TIRS, entitle “The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times.” To download and listen to this free podcast, click here.

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InSites: Medical costs for patients participating in clinical trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

Patients are entitled to understand if their participation in a clinical trial will cost them money. The process of obtaining their informed consent must therefore include information relevant to subject costs and billing. Consider four categories of cost concern: treatment and diagnosis for research-related injury, lost wages, travel-related expenses, and healthcare items and services delivered during the trial. This last category can be an area of confusion for IRBs, investigators, and study teams, except in those cases when 100% of charges are either covered (or not) by the sponsor. I mentioned this topic in one sentence in the previous InSites blog, but it’s worth fleshing it out further. Continue reading

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Incidental data in pharmacovigilance

Drug regulations require that adverse event reports received by pharmaceutical companies must be entered into databases and analyzed for the detection of safety signals.  In a couple of scenarios, these strict regulations are leading us to add what has been called “incidental data” to our safety databases, which can actually make the identification of new safety issues more difficult, rather than easier.  Continue reading

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InSites: New FDA Guidance on Informed Consent

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

On July 16th, FDA released its: Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and SponsorsWhen finalized it will replace the 14-year-old, A Guide to Informed Consent. At 42 pages, it is as long as some informed consent forms (ICFs). Continue reading

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