CRO’s And Conflicts Of Interest: Vote Here
3 CommentsBy Ed Silverman // July 6th, 2007 // 5:57 pm
The commercialization of clinical trials is becoming a hot topic. This week, we learn that Pfizer is telling its best trial sites to sign exclusive deals or find other business. And then there was the tale of PPD, the big clinical research organization, which took a big stake in cash-starved Accentia BioPharma and hopes to earn 14 percent on royalties if a sinus drug its testing for the company gets approved by the FDA.
Beyond the excitement of a good deal for whichever corporation is involved, at issue is the patient. The PPD deal with Accentia was criticized, by some, as a conflict of interest, while others either defended the arrangement or downplayed any problems. So we asked you to vote whether the deal - which you can read about here - is, indeed, a conflict. You can vote as soon as you finish reading. The polls are staying open through the weekend. Please tell us what you think.
Rick
Why is it any different having a CRO with a vested interest in a product or having the company run it’s own trials. The argument is moot unless you believe that large pharma shouldn’t be allowed to run their own studies, collect the data and generate reports to the FDA. This is what drug development is about. Finding products that may help patients and excite investors - as long as the data is collected using GCP following strict guidelines there is no conflict.
Ed Silverman
Hi Rick,
Yes, I acknowledged that point in my original post, which hopefully you saw. And, in fact, that gave impetus to my question about this issue, leading me to suggest that more oversight might be a good thing. And then I wondered what others think. There is no easy answer to this issue, as with most things. But hopefully, some discussion can lead to better understanding, and maybe changes, when warranted.
Thanks for writing in,
ed s
Chris
Ed,
You make a fair point that oversight is important and will always be so for the safety of patients/subjects in clinical trials. I believe that CROs should be able to invest in companies, whether clients or not, and to conduct trials on their behalf. All trials are conducted under full ethical and protocol review and subject to just the same scrutiny as for those conducted for any other client. They are no different to a pharma company’s protocols and so have no loop hole to exploit, as some might be suggesting.
What may be worth reinforcing is the risk that CROs - and the companies involved - would take on if they were stupid enough to manipulate results. As I said already it would be extremely tricky to do so, and there is no motive to do so when their bigger business is concerned. The potential benefit in a rise in the share price of a company in which they are invested is minimal compared to the bomb that would fall and the destructio of their business if any wrongdoing was seen and proved. It’s not worth it financially and they are too smart to take a short term risk and ruin a long term business.
Good topic by the way,
Chris