Why are so many pharma-sponsored studies poorly constructed?

Posted 19th August 2010, 11:50:58

I was reading the topic Importance of Systematic Reviews in Pharmaceutical research, posted by cpnjaved, with great interest and I guess the follow-on from that is to wonder why it is that so many pharma-sponsored studies are poorly constructed, with the result that they contribute little, if anything, to the wider knowledge base.

The cynical answer might be that it means the results cannot be properly scrutinised when discussing treatment benefits associated with a given drug. However, I don't believe that can always, or even often, be the case. Yet there must be some reason(s), given that it is so common.

Posted 6th September 2010, 14:13:37

Hi londonlife,

Welcome to the forum! It's an interesting area, but can you expand on what you mean by poorly constructed?

Thanks,

Paul.

Posted 16th September 2010, 14:02:44

Simple fact is that pharma is not going to pay more for a broader research study if it does't contribute to getting the drug to market. It's not to say that pharma doesn't do some philanthropic things, just not in this way. It's high expense and low visibility.

Posted 16th September 2010, 20:25:52

Hi Paul.

What I mean is that they often seem to have non-randomized or unusual structures, inappropriate controls, tiny sample sizes, short or meaningless follow-up periods and the end points that don't translate readily into clinical practice.

I take amino's points that, in essence, it isn't pharma's job to further the wider knowledge of science and medicine, but what I am saying is that, in trying to get a drug to market, pharma hamstrings itself in carrying out studies that are so wide open to criticism and dismissal of the findings that it sometimes makes the exercise a bit pointless.

I realise that the studies are typically designed to play to the strengths of a new treatment, but a better balance between the needs of pharma and the need of the wider community to understand the actual relevance would be desirable.

Posted 17th September 2010, 17:29:01

Hi londonlife,

OK - thanks for clarifying. Yes, I think some of that has certainly been true. Perversely enough I see the rise of market access as pushing pharma to be much more stringent about its trials and setting them up correctly, as the drugs just won't get past the fourth hurdle.

I'm not sure this helps in the broader sense though as it is probably encouraging testing in narrower, more tightly defined populations which are seen as least risk / where the drug has the most benefit.

Posted 19th September 2010, 12:00:09

This is fascinating. What happens when charities get involved, are there wider benefits considered during the planning? You wouldn't think there was a problem if all you saw were the big landmark trials announced at conferences and published in the big journals - they seem to work well for the drug firms as well as the wider knowledge base.

Posted 28th September 2010, 16:10:15

I'm not sure many of the charities have the money to get heavily involved in this kind of work. Even if they did I'm not sure it would sit comfortable with a pharma led trial.

Posted 1st October 2010, 20:16:02

Interesting point, richard1972, about you wouldn't think there was a problem if all you saw were the big landmark trials announced at conferences, etc. However, I was at the ESC this year, sitting in the main hall listening to landmark trial after landmark trial (I know, they can't all be landmark, but there were certainly billed as such). They were all so convincing and so robust. Until the Discussant stood up, that is, and ripped them to shreds. In some cases, it was embarrassing to watch. Yet is the Discussant's valuable work, and are their valuable arguments, even taken into account when looking back at these trials? Hardly ever.

It was so obvious once they looked beyond the top line or paused for more than the two seconds given to the graphs in the original presentation. So many trials presented in the main hall were, virtually, worthless. And yet so much amazing, worthwhile and revealing work, often not pharma-sponsored or pharma-constructed, was presented in the side halls.

Agreed about the charities, amino. Their valuable status may be at stake if they get too involved, surely?

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