Peter, I don't know how many are aware of the role of the Hospital Internal Review Board process. Some companies will not announce the start of a clinical trial until a desired percentage of total centers are on board. By the time this occurs hundreds of people directly know a lot about the planned trial. Here are two post by a 15 year member of such an internal review board.
SECOND POST
BubbaRayJR
1/12/01 9:28 pm
I'm really surprised that, (edited out by me g.w.), chooses not to make this information public. Any IRB
that reviews their study knows what they are testing, what they hope to accomplish,
how many patients they plan to enroll, and more importantly (from an investors point
of view) how likely they are to achieve that goal (# of patients enrolled). Often the
study's exclusion criteria is so restrictive that it's obvious the investigator will never
enroll enough patients. We've had several studies that were approved, but enrolled very
few patients before they were terminated. The study design is critical. I've invested in a
company called POSSIS that may be having similar problems with their TIME I study.
They started the study last spring and enrolled only 5 patients before announcing that
while their technology successfully removed the clots, they needed to "tweak" the
study, the catheter (which removes the clots) and improve physician techniques. I
believe their technology will pay off and this "tweaking" early in the study tells me that
they are on top of the problems. I wish I could read the investigator's study material.
This information is extremely valuable. If you get your hands on this type of
information, pay special attention to the number of patients they want to enroll, the
patient population, the exclusion criteria, necessary monitoring and the adverse effects
expected.
FIRST POST
BubbaRayJR
1/12/01 7:55 pm
George, I've been a member of our IRB for 15 years. The board is made up of six
physicians, two pharmacists, a RN, a clinical research nurse, Chief of Medical Staff,
an attorney not associated with the hospital and a priest. All of the members, except one
pharmacist (the IRB coordinator) vote. Our main objective is to ensure patient safety.
We receive the entire study protocol which may or may not be presented at the
Committee meeting by the investigator. Our Committee reviews the study's science and
Informed Consent. We meet every six weeks and often do not approve a study on the
first review. Most of the problems we find are associated with the Informed Consent.
The Consent must be written on an eighth grade level. If the study is turned down on
the first review, the investigator is told what to correct and then the study will be
considered at the next meeting. When the study is approved it must go through the
Clinical Research office to set up reimbursement, logistics, etc. This may take days,
weeks or months. It really depends on how well the study is being run. We have a
group of investigators that normally receive IRB approval on the first review and often
have their study underway within 2-4 weeks after IRB approval. Once the study is
underway we receive periodic information about adverse effects. We use this
information to evaluate the Informed Consent side-effect/risk section to determine if it
should be changed. Each study is reviewed yearly by the IRB. The investigator must
send information including the number patients enrolled and if the study will continue
to enroll patients. We are not required to keep silent about the information we receive,
patient confidentiality excluded.
I hope this helps. Let me know if you have any more questions. |
