2017

CIA Torture as Human-Subjects Research

Research Ethics Blog

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture. Some of us professionally involved in research ethics governance might not agree that norms of that discipline are beyond debate.

Holiday Gift Guide for Clinical Researchers

GCP Cafe

‘Tis the season once again! It’s time to start thinking up cool gift ideas for your clinical researcher friends and colleagues! … Are you stumped? Here’s a roundup of some of my favorite product picks that are perfect accessories for the CR life. I lovingly curated everything on this list and each item is below $40. 2018 NeuYear Wall Calendar. All of their calendars are really neat, but I like this one in particular. It comes in paper and dry erase and is super functional.

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REMOTE Redux: DTP trials are still hard

Placebo Control

Maybe those pesky sites are good for something after all. It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes. Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283.

7 Steps to a Simply Awesome LinkedIn Profile

GCP Cafe

7 Steps to a Simply Awesome LinkedIn Profile. You hand your business card to a new contact at a networking event and immediately, anxiety washes over you. What if they visit my LinkedIn profile to connect? It is so boring. So embarrassing. So disorganized. Fear not, Clindividual, my entire goal for GCP Cafe is to help you more effortlessly connect with your peers in clinical research.

Navigating your Path to a Clinical Operations Career

GCP Cafe

Transitioning into a Career in Clinical Trial Management (Sponsor). Before I started my career in clinical operations, I was a technician on a production floor manufacturing oncology drugs. I had an unrelated job, and I eventually was able to transition into a clinical operations career at a pharmaceutical company. I needed to identify whether I had transferable skills for navigating a path into a clinical operations career.

What is Clinical Operations?

GCP Cafe

What is ClinOps? In Clinical Operations, a clinical project team contributes to and supports a organization’s research and development program in order to advance new investigational drugs/devices to commercialization. ClinOps delivers an inspection-ready dataset and complete documentation of the clinical activities that can support an NDA / PMA. Core Competencies in a Clinical Operations Professional.

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How may we help you clinical researcher?

GCP Cafe

Vote in the poll and tell us what new content you are wishing for from ClinOps Toolkit. Clinical researcher, your vote matters! What would you like more of from ClinOps Toolkit in 2017? created by Poll. The post How may we help you clinical researcher? appeared first on GCP Cafe. Resources

Clinical Research Reading List – Summer 2017

GCP Cafe

Top 10 Recommendations for Summer Reading and Surfing. How will you pass the time between the Clinops Café series of online meetups? Here are recommended books, videos, podcasts, and articles to spark your clinical research creativity all summer long! Summer is calling me louder than anyone this year. It’s been a particularly wet year in the PNW and I’m looking forward to finally seeing consistent sunshine.

Jennifer Brandl | ClinOps Toolkit Collective Volunteer

GCP Cafe

Jennifer is Our Operations Specialist. Jennifer is a Wisconsin native who has called San Francisco home for over 5 years. An experienced immunology researcher, Jennifer moved into the role of Associate Manager in Clinical Trials Management a few years ago. She is a tireless evangelist with over 10+ years experience in the quest to develop new therapies to transform the lives of patients with cancer. Jennifer is a regular speaker for MAGI, Arena conferences, and other industry events.

Retention metrics, simplified

Placebo Control

[Originally posted on First Patient In ] In my experience, most clinical trials do not suffer from significant retention issues. This is a testament to the collaborative good will of most patients who consent to participate, and to the patient-first attitude of most research coordinators. However, in many trials – especially those that last more than a year – the question of whether there is a retention issue will come up at some point while the trial’s still going.

The Streetlight Effect and 505(b)(2) approvals

Placebo Control

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

Establishing efficacy - without humans?

Placebo Control

The decade following passage of FDAAA has been one of easing standards for drug approvals in the US, most notably with the advent of “breakthrough” designation created by FDASIA in 2012 and the 21st Century Cures Act in 2016. Although, as of this writing, there is no nominee for FDA Commissioner, it appears to be safe to say that the current administration intends to accelerate the pace of deregulation, mostly through further lowering of approval requirements.

Jerry Matczak

Placebo Control

Jerry Matczak passed away suddenly last Thursday at the much-too-young age of 54. I can say, without exaggeration, that Jerry embodied pretty much everything I aspire to be in my professional life. The MedCityNews headline called him a “social media guru”, but in reality he was temperamentally the exact opposite of a "guru": He was constantly curious; it seemed that every conversation I had with him was composed mainly of questions.

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