Well… it’s 2016! Time to put my writing where my mouth is… So, without further ado: “Introducing: Your GCP Nerd”, Eric Klaver!
For the longest time I’ve referred to myself as the ‘Self-Proclaimed GCP Nerd’… Well, in honesty, course participants started. But I found it to be a compliment worthy of adopting!
So what am I going to do with this blog…
Here I’ll be addressing questions from the field and topics that I feel are worth touching upon. Bitesize pieces of ICH-GCP information. Of course ICH, is there any other GCP? Other ICH or clinical research topics may come along, regulation topics, who knows. Topics can originate from course participants, but also from YOU! Feel free to email GCP Nerd with any question you may have.
Today I’m starting my annual Masters module ‘Clinical Development & Clinical Trials’ at the VU Amsterdam University. Who knows what interesting questions will come from that module! I can’t wait to meet the students. Typically around 60 eager brains, wanting to know more about this industry. My year has officially started now that this module has!
An exciting year for GCP
2016 promises to become an exciting year for ICH-GCP. Not only is it 20 years since ICH-GCP was first published, but it’s also the year it’s going to be updated for the first time!
Can you imagine… a guideline in an industry that is SO strictly regulated as clinical research, to have a guideline be SO good that it’s held up for two decades! I can’t help but love it.
And now that it WILL be updated, it’s not even going to be torn apart and overhauled! Excellent topics and needed aspects will be added to the current text.
A rough start for clinical research
Of course 2016 has been up to a rough start for clinical research. “Drug trial participant brain dead, 5 others hospitalized in France” was the header on CNN. Hopefully we’ll soon find out what exactly happened there. But we know that this is always a risk, no matter how small. And we work our hardest to keep this risk as small as humanly possible. The company conducting the testing said on its website the trial was administered “in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial.”
A decade has past since the last big accident. The 2006 trial with TGN1412 in the UK, now in the press referred to as ‘The Elephant Man’ Drug Trial. Inspections there did not find any irregularities in following the guidelines and regulations, although some doubts exist about the extend to which the timing of the protocol was adhered to.
S0, 2016… if ever!
I think all this illustrates that 2016 is THE year for Your GCP Nerd to start his blog. I hope you’ll visit regularly and interact. As said, feel free to send in questions to GCP Nerd!