h2g2 The Hitchhiker's Guide to the Galaxy: Earth Edition

Entry: ICH-GCP 1: A Brief History - A4060441
Author: Varindweion - U1503746

This is my first article in a series of what will probably become three (maybe one more, I'm not yet sure) on ICH-GCP. This first one gives a brief history of ICH-GCP and how it came to be.
The next one will be about Clinical Trials (the four phases) and the third will be about how a trial phase is organized and how it is conducted. These two still need to be written, but I thought I would wait for some comments on this first one, in order to get a better idea on how to proceed.
Enjoy !

This is a good start. However, it thought the reason why thalidomide DIDN'T make it past the FDA was because there was so safety data available, rather than that the existing data showed contra-indications.

That's what I mean by '...reviewed the application thoroughly.' Frances asked for further data and research, several times actually. Eventually there was a researcher who put 2 and 2 together and made the link between the increasing number of birth defects and the increased usage of thalidomide.
You can find the story on the reference "The Thalidomide Incident".

Yes, but I think that this linkage needs to be made more explicit. What's more, it needs to be spelled out that this is the reason why we now do drug safety assessment using animals in the UK.

Ah, but it can't be the reason for animal testing (or shouldn't be), because in this case, the results of animal testing were different than the ones of human testing, i.e. in animals no significant birth defects were noted, as can be read on the reference link.
Besides, it is not my intention to give a full account of the Thalidomide Incident, but just a brief history of ICH-GCP. It is not essential for the rest of the articles. This first part is just intended for what it is: a brief introduction as to how ICH-GCP came to be.
You are welcome however to elaborate on the Thalidomide incident further. As for this article: the text as it is now, may be somewhat brief, but it serves it purpose well: a BRIEF history of ICH-GCP.

'No a priori believe that death or disabling injury will occur, may exist'

This sentence makes no sense at all. Should that possibly be 'belief', with no comma before 'may'? In fact, if that's the case, swap 'may' for should.

'Frances Kelsey (an FDA employee) reviewed the application thoroughly and kept if of the market when she discovered that it caused birth defects when used on pregnant women.'

This doesn't make sense either. I'm guessing that should be 'kept it off', not 'kept if of'.

I'd also recommend changing the title, as in its current form it doesn't explain the subject at all to anyone not already familiar with what ICH-GCP is already. Furthermore, this may well be the most boring title I've yet seen in my (comparitively brief) time on h2g2.

If you can drag yourself past the stultifying title, though, it's a good, informative article. A little dry for my persoanl taste, but then so is the subject matter.

If you could inject a little human feeling into the article somehow, then it'd be a definite winner.

I think that the drug discovery process as a whole could do with a more detailed treatement. It's big, it's complicated, it's expensive, it's tedious: it would help a very great deal if people knew *why* this was so.

YalsonKSA:
1. sentences: will be adjusted. Consider it a typo, since I am dutch

2. other title: I'll think about it, but since I'm gonna write several articles about ICH-GCP, I need to come up with something kind of format I can use for every article, so I can keep it all within the same line.

3. human feeling: this first part is historical, so I kept it as objective as possible. My idea is to get to the human feeling-part in the forth article. The first three will be factual, but the last one will be about the problems of medical research: pattenting, generic drugs, ethics... It will be with this part that I'll be needing some help in researching. If you feel up to it..
Felonious, this last one is also for you. You seem interested and I think you have a better idea and grasp on writing in a more human style. Let me know what you think.

Something els I'll add in this article: some explanation about the upcoming articles, so people will know what to expect.

Thx for the feedback.

Well there was at least one typo in my post telling about yours, so I know how easy it is.

I'd be more than happy to help. I work in drug discovery, albeit in a secondary role...

Ah, cool. Same for me: Data Reviewer for SGS LSS Benelux, former MSI Mechelen (Belgium). Hence the idea of writing something about ICH-GCP.

Better title?
These are the ones I had in mind for the next articles:

Good whatyamacallit Practice part II: Clinical Research
Goodygoody, Clinical Practice part III: Organisation of a Trial Phase
Good Enough Clinical Practice part IV: Problems and Issues

I don't think the title works, to be honest...

I think I'm gonna return to the previous titles: those were nice and simple and did what a titel has to do: make it known to the reader what the piece is about.

Are the other Entries in any stage of completion? It seems important to me to have 'em all, because the numbering gives it an incomplete feel.

As an alternative, drop the numbers in the title and headers. Post the Entries as standalone versions and in the end write an 'umbrella' Entry linking them together.

Does that make sense?

HELL

I'll be glad to see these in the EG, especially as I would have liked to have linked to the 2nd one from my Entry on West Nile Virus A4540989.

The title for the first one 'Good Clinical Practice' is better tha what you had (ICH-GCP. Evertime I saw this it put into my mind an analytical technique under the abbreviation, ICP -Inductively Coupled Plasma s'thing or other).

I think your second Entry should just be called 'Clinical Trials'

Thanks for the comments, radioactive and Dr. Hell.
I'm still not out of the whole title-issue, but your suggestions are more than welcome.
Dropping the numbers might work and the umbrella piece is a great idea: never thought of that.

I'm currently working on some other projects, so it's gonna take a while until part three and four are ready.

So... For that reason, if you (a) drop the numbers and (b) post them as they get ready as standalone Entries then you don't have a time-pressure problem. The umbrella Entry you finish afterwards withh all the time in the world. I did a similar thing with my AIDS-HIV Entries.



HELL

Anywho: I've dropped the numbers, but I am keeping the first part of each title: "Good Clinical Practice", just to make it clear to anyone who does a search on hootoo, what the article is about. Also, when several of the part appear in a list, it is clear that they belong together.

HELL