It started about 8 years ago when I walked into my then boss's office and asked him what is this GCP ?
Here I was a practicing physician (since 5 years then) and now a consultant physician for this Upcoming CRO. I remember the aghast look on his face (probably reflecting on the uphill task he faced in setting up his dream if all he had were people like me!) and said -"you don't know?"
"Obvious isn't it,"said I,a little taken aback with this violent display of emotion.
"Good Clinical Practice ."-said he through clenched teeth.
"Aha,"said a very relieved me,"I know about that,I have a clinical practice and its doing very Good,but what I don't understand is why do you have to send people to workshops to do that?
How does it help?"
By now his face was changing colours and am sure his B.P up a notch or two and I decided to beat a hasty retreat and try finding out for myself.
So ,I did find out that it is a set of Guidelines (in fact many sets of guidelines-Internationally harmonised and yet ironically country specific sets too,) which clinical investigators and their teams promise to comply to when conducting research, to ensure patient safety and data credibility.
That was then ,and this is now.
Much water has flown under the bridge and almost everyone in this industry knows about ICH GCP.
About GCP that is , but knowing or understanding GCP, well, that is another question!
Now I conduct several training workshops around the country,including ones on ICH GCP.
One of the questions that I almost always ask while in there is -What does ICH in ICH GCP stand for?
More often than not ,the looks that I receive are quite akin to the one my ex-boss gave me that morning 8 years ago.
Is this a question or what?
And the answer I get almost in unison is-International Conference for Harmonisation!
Satisfied faces all around!
'Great'' say I ,"and what are we harmonising ?The arts,the science,mp3 formats or the blueness of blue jeans worldwide? What is it that this International Conference of Harmonisation seeking to harmonise?"
It is rare that I have somebody instantly answer-It is the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human use.
No,I am not suggesting that one needs to be memorising all abbreviations to be knowledgeable ,all I am driving at is the need for some native curiosity ,to wanting to know more than the information that is supplied ,to seek,to question ,to analyse......basically to research!
Isn't that what Clinical Research is supposed to be about?
But how much of the clinical research industry in India is research and how much of it is just an industry......is another blog away.
Meanwhile do write to me and if you would have an any GCP issues that you would like to discuss,feel free to ask.
I would love to be able to help you.
Anupama
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5 comments:
Is this Harmonisation applicable for the studies conducting all over the world? Or for some particular coutries?
What is the meaning of "SUSAR"?
Jayesh & Dilip
Is harmonization working around? I am still amused. If harmonization is working then why one should do bioequivalence studies for EU & US FDA differently??? Vishal
The ICH process seeks to harmonise many issues in Safety,quality ,efficacy and multidiscplinary areas,but apart from these, there are the country specific reguations or laws so to say.The CFR in USA or the EU directives in Europe for instance and these differ for each country and therefore we end up doing different studies for each regulatory agency.
Ultimate harmoniastion is still a pipe dream!
SUSAR in clinical resaerch stands for Suspected Unexpected Serious Adverse Reactions ,and such AE's come under expedited reporting to the applcable regulatory bodies as well as the Ethics Comittees.
Europe,U.S.A and JAPAN are the countries that form the steering committee of the ICH,with representatives from the government as well as the PharmaceuticalIndustries of each of these regions.In March 1999,The ICH Global Cooperation Group (GCG)was formed as a subcommittee of the ICH steering commitee.
The GCG is made up of one representative from each of the six parties on the ICH Steering Committee, plus the ICH Secretariat at IFPMA. The ICH Observers (WHO, Canada and EFTA) are also part of the GCG. Other regional harmonisation initiatives (RHIs), namely Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and Southern African Development Community (SADC), have been invited to designate permanent representatives to the GCG.
The harmonisation process begun in the late 80s.It isn't the end of road yet and the process is continuously ongoing.
Globalisation is the buzzword all round!lets see where it goes.
Thanks for the clarification... &
What is your opinion with respect to direct entery in CRF instead of generating the source notes?
is it necessary to generate source notes every time & then transcribe in the CRF. I understand certain source notes are required such as confirmed diagnosis of diseases, diagnostic reports or laboratory reports. Can't investigator & team directly enter the study information in the CRF?
Usually sponsor/CRO is not comfortable with direct entery as investigators are not well trained in filling CRF directly or they do not want dare against regulatory in case they ask for some source notes.
The reason I felt is it may save lot of time & unnecessary administrative cost involve in generating the source notes & transcription.
I observe that in lot of trials source notes are exactly the replica of CRF then why not enter in the CRF directly.
I want your expert opinion in this issue as there is no clarity in hot issue. I feel these are some of the things which keeps drug develpmental cost high due to by eating the time of investigator & study co-ordinator, delay in recruitment as they are frustrated with unnecessary documentation apart from their busy practice
Thanks Vishal
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