Bad Behaviour by Pharma, and Unforeseen Consequences

Research Ethics Blog

This is a must-read for anyone interested in the ethics of drug development and clinical trials. It explores how genuinely bad behaviour on the part of pharmaceutical companies can lead to overreaction by journalists and the public, sometimes with tragic consequences. By Matthew Herper, writing for Forbes.com: How Marketing And Media Muddled The Truth About The Heart Drug Vytorin. Big bad drug companies make it easy to fall into a kind of conspiracy-thinking mentality.

How to Network with ClinOps Toolkit

GCP Cafe

ClinOps Toolkit Grows Again! We’re building a community for established clinical research professionals to meetup, share best practices for managing clinical trials, and voice issues and concerns from the everyday (or not so everyday) challenges in clinical trial operations. What’s in your ClinOps Toolkit? What skills do you need to focus and grow?

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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Placebo Control

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Unbelievable but true if #Path2Cures becomes law. pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials.

Is there a “Right to Try” Experimental Drugs?

Research Ethics Blog

From The State Journal-Register (Springfield, IL). Patient freedom, ethics at the heart of ‘Right to Try’ push in Illinois. Some doctors worry that an effort to grant terminally ill people more access to unproven drugs might offer them false hope or even be harmful, but advocates for a “right to try” say patients should have more opportunities for treatments that could extend their lives.

Should a University President Resign over Research Ethics?

Research Ethics Blog

In this newspaper editorial, a former governor of Minnesota says that the current president of the University of Minnesota needs to go, because of how he has mishandled controversy over research ethics at the university: Markingson case: University of Minnesota can’t regain trust under current leadership. …During his first year at the university, Kaler had to make a major decision.

Ethics of Research on Complementary & Alternative Medicine

Research Ethics Blog

Here are three related items to bring to your attention: On the blog of Policy Options magazine, here’s a very good piece by our pal Tim Caulfield, called Homeopathy and the ethics of researching magic. And via the same outlet, here’s my piece in which I partly disagree with Tim: Homeopathy and Research Ethics. And just recently, An anonymous Canadian foundation grants $3 million to study naturopathic oncology.

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How to Improve Medication Adherence in Clinical Trials

GCP Cafe

[box style=”0″] We met the contributors for today’s guest post through their promotion at the DIA 2015 conference and they kindly agreed to provide an article on Medication Adherence.

GCP Video Series: Audit and Inspection of Clinical Trials

GCP Cafe

[box style=”0″] Please subscribe to the Good Clinical Professionals series on our YouTube channel (link). Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month. He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Professional! Connect with Daron on Twitter @Scott_Daron.

Increase Patient Safety: Quality Clinical Trial Data

GCP Cafe

Do deep analysis to ensure quality clinical trial data. Nancy Isaac joined us for the June 2014 panel discussion of ‘Leveraging Real-Time Reviews: Quality Clinical Trial Data’ In an industry where clinical trial protocols are becoming more complex, it is more critical than ever to leverage real-time reviews of clinical outcome data. Our panel of clinical trial experts shared their specific experiences, challenges, and insights on obtaining and managing quality clinical trial data.

Have you met Daron Scott?

GCP Cafe

Meet Daron. Daron Scott, Senior Contributor – ClinOps Toolkit. What gets measured gets managed. Peter Drucker. Mr. Consistency. I am lucky to call Daron the original ClinOps Toolkit Volunteer Contributor and also my friend. Daron is not Mr. Agreeable, or Mr. Social-Hour, or Mr. TellMeAboutYourFeelings, but he is absolutely Mr. Consistency. His personality, difficult to tap, and in all areas my opposite, makes him perfectly suited for strategic planning.

4 things that Inhibit our Communication

GCP Cafe

Every CRA job description lists excellent communication skills — but how often do we think about what that means? The CRA role is task oriented and technical, however if you have poor communication skills you will be far a less effective CRA. This is a brief look at some of things that inhibit communication. Lack of clear communication in clinical trials causes misunderstanding resulting in costly delays. It has a negative impact on efficient use of resources.

CRA Superhero

GCP Cafe

[box style=”4″] The CRA Superhero. uses her special powers. to ensure patient safety. tirelessly defending the integrity of all data. governed by GCP. and fueled by espresso and sugar. leaping over towers of CRFs. cleaning up oceans of data. helping all the poor, tired , and defenseless study coordinators. to click click click. and solve all the queries. brave, fast , and smart (never omitting an oxford comma). solitary. extraordinary. while you rest. she continues on.

ClinOps Toolkit Listens. How may we help you?

GCP Cafe

If you want to help others, you first have to listen. I did not listen. When I was in preschool, I had difficulty hearing. At first, nobody realized I was struggling to hear. I just remember how I felt alone when the children wouldn’t play with me. Swinging in the school yard, other kids ignored me. I know now that I ignored them. Other children would talk to me but I never LISTENED.

GCP Video Series: Risk Assessment Monitoring

GCP Cafe

[box style=”0″] Please subscribe to the Good Clinical Professionals series on our YouTube channel (link). Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month. He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Pro! Connect with Daron on Twitter @Scott_Daron.

Secret Formula to be the Best Clinical Trial Site

GCP Cafe

The Best Clinical Trial Sites are Empowered. The best clinical trial sites have laser-focus on the ultimate goal to advance treatment options for their patients. The best sites perform all trial activities and procedures with the highest attention to quality and adherence. Sponsors will reward for this performance and clamor to work with these sites again on future trials.

Medidata Talks RBM with ClinOps Toolkit for SCOPE2015 Conference

GCP Cafe

[box style=”0″] Our First Interview in the GCP Series. Our 2015 ClinOps Toolkit video interview series introduces you to two of our favorite industry thought leaders and Good Clinical Professionals (GCPs)! Kyle Given and Barbara Elashoff of Medidata kindly agreed to sit down with us for an interview to discuss risk-based monitoring (RBM) and Barbara’s SCOPE 2015 presentation. [/box] box] Medidata Talks RBM. Big data is being generated by everything around us at all times.

Introducing the GCP Video Series by ClinOps Toolkit

GCP Cafe

GCP Video Series. I am delighted to announce the GCP Video Series by ClinOps Toolkit. Here, GCP stands for Good Clinical Professionals! We have filmed two interview style videos already and I have filmed two vlogger style videos. It has been a lot of fun learning more about this medium for communicating with you all. We wrapped up our edits on the first video this week and you will see it posted here next week with an expanded transcript.