Clinical trials funding

Clinical Alerts Reports the release of findings from the NIH-funded clinical trials where such release could significantly affect morbidity and mortality http yywww.nlm.nih.gov/databases/alerts/clinical alerts.html... 

The Urological Sciences Research Foundation is a nonprofit organization based in California. It solicits money to fund clinical trials, focusing on prostate disease, erectile dysfunction, overactive bladder, and incontinence. Many of its industry sponsors are well-known pharmaceutical and medical device companies. 

Antman, K., S. Lagakos, J. Drazen (2001). Designing and funding clinical trials of novel therapies. New England Journal of Medicine 2001 344 762-3. 

The argument is often made that African Americans and other ethnic minorities do not participate in clinical trials because they do not want to. African Americans in particular were thought to be suspicious of participation because of previous experiences of exploitation and manhandling of vulnerable minority groups (Melfi et al, 2000 Corbie-Smith et al, 1999). The Tusgekee syphilis study is often cited as a reason for mistrust (Shavers et al, 2000 Shavers et al, 2002 Corbie-Smith et al, 1999). This study was a federally funded study of the long-term consequences of syphilis on African American men initially started before antibiotics were available. 

NIMH (2005). Treatment Research in Mental Illness Improving the Nation s Public Mental Health Care through NIMH Funded Interventions Research. Report of the National Advisory Mental Health Council s Workgroup on Clinical Trials. Washington, D.C. 

In fact, studies funded by drug companies usually show positive effects of their products and worse results for the products of their competitors, whereas studies that have been independently sponsored show results that are midway between these two extremes. A team of researchers at the Beth Israel Medical Center in New York have examined the outcome of clinical trials as a function of who had sponsored them. They found that approximately 75 per cent of drug-company studies showed favourable results for their own drugs, but only 25 per cent of them showed favourable results for the product of a competing... 

While the numbers of animals involved in research is tracked closely and is well known, such is not the case for human subjects involved in clinical trials. We simply do not know how many are involved in such trials in the United States, much less worldwide. Though the NIH does track closely how many dollars and individuals are involved in research it funds ( 12.7 billion and seven million subjects in 1997), the same is not true for privately funded research (where the numbers are greater). And while there is now a Web site where one can examine the numbers and types of efficacy trials open, the same is not true for Phase I tolerance and pharmacokinetic trials, where most potential drugs cease development. 

Site management organizations provide physician investigators, qualified patients, and support personnel for inpatient and outpatient clinical trials for single site or multicenter clinical trials. These firms provide services to sponsors and CROs. They are included in the CRO industry revenue totals, and unlike CROs they incorporate per pahent grant funds in their revenues. 

The NIH and the pharmaceutical industry have formed a new partnership to overcome barriers to early-phase clinical trials. The Secretary of Health and Human Services, Tommy Thompson, announced on July 9, 2003 grant awards for six cancer centers involved in a unique public-private partnership. Five pharmaceutical companies together with NCI put forth a total of 5.7 million for this partnership. Institutions receiving the funding include Massachusetts General Hospital University of Colorado Health Sciences Center Washington University, St. Louis University of Pittsburgh Cancer Institute University of California, Davis Cancer Center and Ohio State University Comprehensive Cancer Center (http //WWW. bms.com/news/other/data/pf other.news.385 5. html). 

The total sum of 140 million and subsequent private funding of around 12 million enabled the completion of the phase-three clinical trials with about enough remaining to conduct a second phase-three trial if the PDA did not approve the current NDA. 

The regulations on clinical trial funding differ among hospitals based on their background. For example, in national university hospitals there is a standard table that categorises clinical trial... 

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