2013

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Is there common ground for engagement between doctors and pharma?

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Join a cross-stakeholder panel, including the CEO of Doctors.net.uk, a pharmaceutical industry digital engagement expert and two doctors, to understand areas of mutual interest for doctors engaging with pharma online and the specific types of information and dialogue they are seeking.

Doctors 52
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Patient Recruitment: Taking the Low Road

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The Wall Street Journal has an interesting article on the use of “Big Data” to identify and solicit potential clinical trial participants. The premise is that large consumer data aggregators like Experian can target patients with certain diseases through correlations with non-health behavior. Examples given include “a preference for jazz” being associated with arthritis and “shopping online for clothes” being an indicator of obesity.

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Half of All Trials Unpublished*

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(*For certain possibly nonstandard uses of the word "unpublished") This is an odd little study. Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

Trials 40
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Brave New Biopharm Blogging

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Although a few articles on this site are older, I really only began blogging in earnest about 15 months ago. However, I suppose that's long enough that I can count myself as at least somewhat established, and take a moment to welcome and encourage some interesting newcomers to the scene. Bloggers in dank basements their natural habitat. There are 3 relative newcomers that I've found really interesting, all with very different perspectives on drug development and clinical research: Pharmagellan T

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Counterfeit Drugs in Clinical Trials?

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This morning I ran across a bit of a coffee-spitter : in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their Counterfeits flooding the market? Really? "Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms - the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote: "Locating and accessing these comparators at

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Preview of Enrollment Analytics: Moving Beyond the Funnel (Shameless DIA Self-Promotion, Part 2)

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Are we looking at our enrollment data in the right way? I will be chairing a session on Tuesday on this topic, joined by a couple of great presenters (Diana Chung from Gilead and Gretchen Goller from PRA). Here's a short preview of the session: Hope to see you there. It should be a great discussion. Session Details: June 25, 1:45PM - 3:15PM Session Number: 241 Room Number: 205B 1.

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Can FDA's New Transparency Survive Avandia?

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PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty. I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

Trials 40
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Clinical Trial Enrollment, ASCO 2013 Edition

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Even by the already-painfully-embarrassingly-low standards of clinical trial enrollment in general, patient enrollment in cancer clinical trials is slow. Horribly slow. In many cancer trials, randomizing one patient every three or four months isn't bad at all – in fact, it's par for the course. The most commonly-cited number is that only 3% of cancer patients participate in a trial – and although exact details of how that number is measured are remarkably difficult to pin down, it certainly can'

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Questionable Enrollment Math(s) - the Authors Respond

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The authors of the study I blogged about on Monday were kind enough to post a lengthy comment, responding in part to some of the issues I raised. I thought their response was interesting, and so reprint it in its entirety below, interjecting my own reactions as well. There were a number of points you made in your blog and the title of questionable maths was what caught our eye and so we reply on facts and provide context.

Trials 40
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Questionable Enrollment Math at the UK's NIHR

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There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment. First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had " tripled over the last 6 years ". That announcement, by the chief executive of the Sweet creature of bombast: is Sir John writing press releases for the NIHR?

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Every Unhappy PREA Study is Unhappy in its Own Way

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“Children are not small adults.” We invoke this saying, in a vague and hand-wavy manner, whenever we talk about the need to study drugs in pediatric populations. It’s an interesting idea, but it really cries out for further elaboration. If they’re not small adults, what are they? Are pediatric efficacy and safety totally uncorrelated with adult efficacy and safety?

Drugs 40
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Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

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Results reporting requirements are pretty clear. Maybe critics should re-check their methods? Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Pharma: breaking the law in broad daylight?