akif
☆    

Turkey,
2021-08-24 09:42
(61 d 23:39 ago)

Posting: # 22536
Views: 944
 

 What is most common reason of failure of BE study? [Study As­sess­ment]

Hi Everyone,

Is there any study that evaluate statistically failed BE studies? I wonder what is the most common cause(s) of unsuccessful BE studies. Can some one who have experience about unsuccessful BE study share here? what was the cause for failure?
Helmut
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Vienna, Austria,
2021-08-24 11:32
(61 d 21:49 ago)

@ akif
Posting: # 22537
Views: 856
 

 My observations…

Merhaba akif,

» Is there any study that evaluate statistically failed BE studies?

Not that I recall. Sponsors don’t publish failed studies and – if at all – submit them to agencies. For the only review I know, see this post.

» I wonder what is the most common cause(s) of unsuccessful BE studies. Can some one who have experience about unsuccessful BE study share here? what was the cause for failure?

My personal ranking:
  1. Overly optimistic assumptions about the T/R-ratio leading to a too small sample size.
  2. Assuming a unrealistically low CV.
  3. Design issues (too short washout, metabolite instead of parent drug,…).

Dif-tor heh smusma 🖖
Helmut Schütz
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akif
☆    

Turkey,
2021-08-24 13:59
(61 d 19:22 ago)

@ Helmut
Posting: # 22540
Views: 817
 

 My observations…

Merhaba Helmut,

Thank you for your response. What is your ranking in terms of development of formulation and dissolution studies?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Helmut
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Vienna, Austria,
2021-08-24 14:21
(61 d 19:00 ago)

@ akif
Posting: # 22543
Views: 806
 

 Inveterate optimists…

Merhaba akif,

» What is your ranking in terms of development of formulation and dissolution studies?

Difficult to say. At the end of the day sponsors believe (‼) that the new product is ‘perfect’ leading straightaway to the #1 mentioned above.
I had conversations like this one:

“We don’t understand why the study failed although we had perfectly matching dissolution.”
“What do you expect for your BCS class II (or IV) drug?”
“???”

Oh dear!

Dif-tor heh smusma 🖖
Helmut Schütz
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Ohlbe
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France,
2021-08-24 15:47
(61 d 17:34 ago)

@ Helmut
Posting: # 22546
Views: 789
 

 My observations…

Dear Helmut and Akif,

» My personal ranking:
»
» 1. Overly optimistic assumptions about the T/R-ratio leading to a too small sample size.
» 2. Assuming a unrealistically low CV.
» 3. Design issues (too short washout, metabolite instead of parent drug,…).

The first reason I would put on the list, whether it is the most frequent one or not, is that the test and the reference formulations are simply not bioequivalent.

I think this is important to state, because one of the root causes behind the cases of data manipulation which were reported over the last years appears to be that sponsors consider by default that their product is perfect and that it is the CRO's fault if the study failed. The CRO is under pressure to make the study pass if they want to retain the sponsor for future business. Some education and key messages are needed there.

Regards
Ohlbe
ElMaestro
★★★

Denmark,
2021-08-24 12:27
(61 d 20:54 ago)

@ akif
Posting: # 22539
Views: 838
 

 What is most common reason of failure of BE study?

Hi akif,

» I wonder what is the most common cause(s) of unsuccessful BE studies. Can some one who have experience about unsuccessful BE study share here? what was the cause for failure?

Management. Especially top management.

Pass or fail!
ElMaestro
akif
☆    

Turkey,
2021-08-24 14:03
(61 d 19:18 ago)

@ ElMaestro
Posting: # 22541
Views: 814
 

 What is most common reason of failure of BE study?

Hi ElMaestro,

» Management. Especially top management.

Management of CRO ?


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Ohlbe
★★★

France,
2021-08-24 15:41
(61 d 17:40 ago)

@ akif
Posting: # 22545
Views: 786
 

 The Man in the Armani suit

Dear Akif,

» » Management. Especially top management.
»
» Management of CRO ?

IMHO: management of the sponsor, a.k.a. the Man in the Armani suit. The one who was told not to use that CRO because they're not good, but who decided to go there anyway because they're cheaper. The guy who was told that the study needed 48 subjects, but who decided to go with 36 because someone else told him that should be enough, and it's cheaper. The one who was told that the formulation was not optimal, but who said there was no time (or money) to develop a better one.

Regards
Ohlbe
Helmut
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Vienna, Austria,
2021-08-24 14:07
(61 d 19:14 ago)

@ ElMaestro
Posting: # 22542
Views: 817
 

 Management…

Hi ElMaestro,

» Management. Especially top management.

You speak from my heart.

The worker is not the problem.
The problem is at the top!
Management!
    W. Edwards Deming (Cultural Transformation: A New Way of Thinking)

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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