Cochlear Americas Receives FDA Warning Letter

[R2D2]

Not following clinical guidelines pretty much guarantees that staistics are being manipulated. If you skew your population sample, etc. intentionally to produce the results you desire you are manipulating statisticsal results.

Did they skew their population sample? If so, could you please provide some information aboiut this. As I understood it was a problem with the procedural paperwork not the conduct of the actual clinical trials themselves e.g. consent forms not being signed at the right stage of the trial.

 

[jillio]

Did they skew their population sample? If so, could you please provide some information aboiut this. As I understood it was a problem with the procedural paperwork not the conduct of the actual clinical trials themselves e.g. consent forms not being signed at the right stage of the trial.

And you actually believe if they aren't getting consent forms signed that they are following all other guidelines? If there is a problem with the paperwork, there is a problem with the data collected in the clinical trial. I do research on a daily basis and if all guidelines are not followed, the data is contaminated and not usable. That includes right down to the simple instructions given at the very beginning of the research session. Change one oword from the last session, and you have contaminated your control.

 

[R2D2]

And you actually believe if they aren't getting consent forms signed that they are following all other guidelines? If there is a problem with the paperwork, there is a problem with the data collected in the clinical trial. I do research on a daily basis and if all guidelines are not followed, the data is contaminated and not usable. That includes right down to the simple instructions given at the very beginning of the research session. Change one oword from the last session, and you have contaminated your control.

Okay, that's your opinion and you are entitled to it. Your opinion would be influenced somewhat by your personal beliefs. I just wanted to check if you actually had any hard facts but the answer is "no".

If the data is seriously contaminated as you suggest, then I am sure that the FDA would have written warning letters about that rather than focussing on the smaller issue of consent paperwork. The level of contamination that you suggest is extremely serious.

Fortunately there is a whole raft of independent studies performed by academic institutions around the world in this area.

 

[jillio]

Okay, that's your opinion and you are entitled to it. Your opinion would be influenced somewhat by your personal beliefs. I just wanted to check if you actually had any hard facts but the answer is "no".

If the data is seriously contaminated as you suggest, then I am sure that the FDA would have written warning letters about that rather than focussing on the smaller issue of consent paperwork. The level of contamination that you suggest is extremely serious.

Fortunately there is a whole raft of independent studies performed by academic institutions around the world in this area.

Of course my opinion is influenced by my personal beliefs. Whose isn't? That's inherent in an opinion. And when I was explaining contaminated data, I was explaining the guidelines governing whether data can be considered to be contaminated or not. Not just this clinical trial, but any clinical trail. Those are the standards that all research is subject to.

 

[R2D2]

I understand that Cochlear has compromised themselves in their procedure with paperwork and hope that they will implement improvements, mainly to avoid being discredited by critics who are quick to latch on to any problem no matter how small. I understand the concept of data contamination, having taken a paper in statistics at university and I understand that the mistakes they made contaminates the data not directly but by way of being compromised.

However, I wonder considering the facts available about the nature of the shortcomings, whether it's an overreaction to suggest that we might as well discard all data they have ever produced because (in your opinion) they are money grubbing profiteers with no concern for their clients and (following from that opinion) the trials themselves must be suspect too with other problems that we don't know about.

Would your university discard a whole clinical trial and any other one done at the university if it was found that there was a similar low level procedural shortcoming in one trial? Or would they simply implement a review and change their procedures for the future?

 

[jillio]

I understand that Cochlear has compromised themselves in their procedure with paperwork and hope that they will implement improvements, mainly to avoid being discredited by critics who are quick to latch on to any problem no matter how small. I understand the concept of data contamination, having taken a paper in statistics at university and I understand that the mistakes they made contaminates the data not directly but by way of being compromised.

However, I wonder considering the facts available about the nature of the shortcomings, whether it's an overreaction to suggest that we might as well discard all data they have ever produced because (in your opinion) they are money grubbing profiteers with no concern for their clients and (following from that opinion) the trials themselves must be suspect too with other problems that we don't know about.

Would your university discard a whole clinical trial and any other one done at the university if it was found that there was a similar low level procedural shortcoming in one trial? Or would they simply implement a review and change their procedures for the future?

I din't mean to suggest that all data should be scrapped. Just the data that was collected during the breach in procedure. However, discarding that data will also affect the total data on a statistical analysis level.

Any data that was contaminated would be thrown out. If there were 5 participants in a session, and that data was contaminated through procedure, then all 5 participants data would be thrown out. If the procedural inconsistencies had continued over a period of 10 session, then all data for all participants in those 10 session would be disgarded.

 

[R2D2]

Yeah, but that's the whole point. From the information that was provided in this case the shortcomings did not directly affect the data. It involved the manner in which paperwork consent was obtained from the parcipants of the trial.

 

[shel90]

Clinical study and clinical trial fall into the category of research. Maybe I should have been more specific. The information that is obtained and analyzed through the use of statistical procedures determines whether a surgical procedure or a particular product is offered on the market. If clinical guidelines are not followed, inaccurate information is being released to the public.

That's why I said research in the first place. Ok got it, Jillo. Thanks!

 

[jillio]

Yeah, but that's the whole point. From the information that was provided in this case the shortcomings did not directly affect the data. It involved the manner in which paperwork consent was obtained from the parcipants of the trial.

And that is a breach in procedure that would require data to be discarded.

 

[jillio]

That's why I said research in the first place. Ok got it, Jillo. Thanks!

You are very welcome!!

 

[R2D2]

And that is a breach in procedure that would require data to be discarded.

Not because there was anything wrong with the data per se but because of the negative association with the breach, which is seen to compromise the validity of the trial itself.

Looking at the big picture here, we do not see a long history of Cochlear Americas receiving FDA warning letters for their clinical trials. I think we can be fairly confident that the data from their trials is fairly accurate, especially since it has been supported by independent studies conducted elsewhere.

In other words when a body of research is built up, it lends support to certain conclusions and hypothesis.

 

[jillio]

Not because there was anything wrong with the data per se but because of the negative association with the breach, which is seen to compromise the validity of the trial itself.

Looking at the big picture here, we do not see a long history of Cochlear Americas receiving FDA warning letters for their clinical trials. I think we can be fairly confident that the data from their trials is fairly accurate, especially since it has been supported by independent studies conducted elsewhere.

In other words when a body of research is built up, it lends support to certain conclusions and hypothesis.

Perhaps you can be confident, but any breach in procedure leads me to question validity, and that is based on direct experience with research and procedure.

 

[R2D2]

Perhaps you can be confident, but any breach in procedure leads me to question validity, and that is based on direct experience with research and procedure.

Are you talking about the data from all other previous, unrelated trials from the same company that has already been reviewed and okayed by the FDA?

 

[jillio]

Are you talking about the data from all other previous, unrelated trials from the same company that has already been reviewed and okayed by the FDA?

No, just the data where the breach occurred.

 

[R2D2]

No, just the data where the breach occurred.

Okay, fair enough.