I would ike to take your advice in this issue.
> I am really new to clinical trials I have been requested to assist in
> the ANALYSIS of ongong study to test a new marketed drug of diabetus in
Saudi Arbia, In this
> study a cross-ovre design was used, Patients were assigned randomly to
> three groups the new drug, old drug and placebo
> pATIENTS WILL BE ENROLLED FOR 32 WEEKS IN THE STUDY. 16 WEEKS FOR EACH
> PHASE with two weeks as a washout peiod in addition to two weeks at the
> beginning as running period to determine the controlling dose.
> So far we managed to recruit around 55 patients who concluded the
> study in addition to around
> 20 pts who only completed phase 1. We found difficulty in
> recruiting more pts. My questions as follows
> Do you think this sample is enough compared to other similar studies
> 2, Preliminary analysis shows that there are few significant differences
> in some of the tests when we used ANOVA and multiple comparisons.
> In addition we found more significant difeerences in dose amount
> irrespective of the drugs. How can we explain this
3. The dropout rate is very high in one of the groups (may be the
placebo group) Is there anyway to manage this?
I sent this message before to the list members. I hope this time I get at
least
one response
Best reagrds
Dr. Mohi Eldin Magzoub
Riyadh
Saudi Arabia
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On Tue, 30 May 2000, Janet Martin wrote:
> I agree with Jeanne, who said "I suggest that we start another list: RCTs that are ignored."
>
> A list such as this may help to give some indication regarding what types of 'good studies' tend to be translated into practice, and what types of 'good studies' tend to get ignored. This could also help to generate some hypotheses about what characteristics of 'good studies' tend to meaningfully change prescribers' practices...and this could lead to some very interesting research to test those hypotheses!
>
> My nomination for 'good research' that has largely been ignored in our area is the treatment of acute variceal hemorrhage with octreotide or somatostatin. The Cochrane SR demonstrates that there is no clinically significant benefit to treating AVH with octreo/somatostatin; however, many of our prescribers cannot be convinced. The opportunity cost is HUGE!
>
> Janet E. Martin, BScPharm, PharmD
> Project Leader
> Evidence-Based Prescribing Initiative
> London Health Sciences Centre, Room 121B
> 375 South Street
> London, Ontario
> CANADA N6A 4G5
>
> tel: (519) 685-8500 ext 77814
> fax: (519) 667-6811
> [log in to unmask]
> _____________________________________________
>
>
>
> <<< Jeanne Lenzer <[log in to unmask]> 5/26 1:20p >>>
> I suggest that we start another list: "RCTs that are ignored."
>
> My first nomination is screening and treatment for prostate cancer (this is
> a multi-billion dollar industry in the U.S. despite randomized, controlled
> studies that fail to show benefit).
>
> jeanne lenzer
>
>
> -----Original Message-----
> From: Djulbegovic, Benjamin [SMTP:[log in to unmask]]
> Sent: Friday, May 26, 2000 11:56 AM
> To: 'Evidence-based discussion group'
> Subject: Evidence that changed medical practice....
>
>
>
> Dear colleagues,
>
> Several months ago I attempted to perform a survey regarding the
> issue so often discussed among the members of this discussion group. That
> is, among hundred of thousands of the trials that we so far performed, can
> we actually identify those great ones that have had the major impact on
> medical practice. Many people responded to a survey-some with a concrete
> examples and some with general comments or thoughts regarding this
> initiative. I thank them all, and hope they will continue to contribute to
> future modifications and update of the list.
>
> Undoubtedly, this is enormous and ambitious task and a survey such
> as this cannot come even close to identify all evidence that has been
> accumulated over years and that changed our practice. Yet, the issue will
> not go away, and will likely will be asked more forcefully in years to
> come.
> So, as imperfect as it may be, here is a list of the trials which in
> opinion
> of some members of this group could qualify as EVIDENCE THAT CHANGED OUR
> PRACTICE. To review it, please go to
> http://www.hsc.usf.edu/~bdjulbeg/oncology/practice-change.htm
>
> You will notice there are actually two lists (1. RCT that changed
> the practice, 2.Non-RCT that changed our practice). Of interest is that a
> list of Non-RCT with the major impact on medical practice is much shorter.
> Could it be that is because breakthroughs in medicine are so rare, and that
> most of advances in therapeutics can only come from a rigorous empirical
> testing in RCTs? Perhaps the lists provided here can further contribute to
> this key, albeit admittedly a combative issue- where should resources be
> allocated: to basic science research vs. clinical research (so called, NIH
> vs. Cochrane model).
>
> I am hoping that exposing these lists to open discourse, over time,
> perhaps we may actually compile the COMPLETE and universally ACCEPTED list
> of all trials that changed clinical practice.
>
> I would appreciate any further thoughts and contribution to this
> initiative. Thanks.
>
> ben djulbegovic
>
> Benjamin Djulbegovic, MD,PhD
> Associate Professor of Medicine
> H. Lee Moffitt Cancer Center & Research Institute
> at the University of South Florida
> Division of Blood and Bone Marrow Transplant
> 12902 Magnolia Drive
> Tampa, FL 33612
>
> Editor: Evidence-based Oncology
> http://www.harcourt-international.com/journals/ebon/
>
>
> e-mail:[log in to unmask]
> http://www.hsc.usf.edu/~bdjulbeg/
> phone:(813)979-7202
> fax:(813)979-3071
>
>
>
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