clinical trials

Note to File – Ep 5 / A Rising Tide Lifts all Ships

Clinical research sites can tend to be very tight-lipped. They don’t always like sharing a great deal of information with other sites.

While this is somewhat understandable given the competitive nature of securing trials, I want to encourage more sites to be transparent and add value in their relationships with other clinical research professionals.

At the end of the day, the more we share, the better off we all are.

Note to File - Ep 4 / CRAzy Train

Scan a document. Update a query for the 6th time. I even once had a CRA ask me to reorganize 25 patient binders to her liking – and I did it! I’ve since grown a lot more discerning when it comes to CRA demands.

These are relatively small and inconsequential requests that we all begrudgingly comply with, but CRAs contribute a great deal to how studies are managed at the site-level. I’ve been asked to withdraw patients, revise AE descriptions and submit protocol deviations under questionable circumstances by more than one CRA.

While I always advise coordinators to maintain a friendly and professional relationship with your CRA, it is equally important to use your best judgement when receiving requests. If an auditor shows up at your door, you (and ultimately your PI) will be responsible for how patients and studies are being managed at your site.

All this being said, an overwhelming majority of CRAs are knowledgeable, helpful and great at what they do. I know many are overworked and underappreciated so please don’t consider this a critique of CRAs, but rather a reminder to use your best judgement and not simply do as you are told.

This Week in Research - Volume 3

Over half of approved cancer drugs from 2009-2013 show no benefits for survival or wellbeing. 

Why you should get a flu shot - even if it won't keep you from getting the flu.

Obesity rates continue to rise.

Psilocybin to treat depression?

The Chinese government has agreed to accept data from clinical trials conducted outside China for the approval of new drugs.

This Week in Research - Volume 2

Hello and welcome back.  Here's what's been happening in the world of research in the last week:

Researchers discover a potential link between onset of blood pressure in mid-life and a risk of developing dementia later in life. 

A "universal" flu vaccine is preparing for phase 2 trials.

NIH's revised definition of "clinical trial" may make autism research more difficult to perform.

A rise in blood pressure during pregnancy linked to childhood obesity.

FDA approves the first glucose monitor that doesn't require a finger stick.

 

This Week in Research - Volume 1

Welcome to our inaugural edition of This Week in Research.  We'll bring you the most interesting news in clinical research weekly.  Enjoy.

Yet another promising Alzheimer's drug has failed phase 3 trials.

Trump's proposed immigration policy may slow the conduct of clinical trials.

Minorities are sorely underrepresented in cancer clinical trials.

Research suggests binge-watching TV can increase your risk of developing Alzheimer's disease and diabetes

Microsoft is using AI to help aid medical research.