The 10-page overview of the clinical research process was prepared as a background document for CIRM's strategic planning process. The paper covers drug development timelines, clinical networks and difficulties in financing clinical research in addition to issues involving academic medical centers.
On the subject of the centers (AMCs), here are a few excerpts:
"We have heard anecdotally of the increasing difficulty that academic researchers face in obtaining funding for investigator-initiated research, which is due to a number of reasons:
"a. Decreased clinical margins at AMCs resulting in less discretionary funding available for research.
"b. The shrinking of the NIH budget.
"c. The general unwillingness of the pharm/biotech industries and the venture capital community to fund research that does not have direct, obvious commercial applications.
"In addition, while academics may sometimes believe that clinical research depends on the AMC, non-academics believe that clinical research, to truly thrive, needs to be present in multiple venues of care. The pharmaceutical industry is seeking more non-academic providers to conduct clinical research, which is creating enormous opportunities for hospitals, physicians and outpatient providers such as the for-profit contract-research organizations (CROs) and site-management organizations (SROs) to fulfill some of the functions traditionally carried out by AMCs. For example, at the beginning of the decade of the 90's, 80% of industry-sponsored clinical trials were placed in AMCs; by 1999 the number was down to 40%. One reason given for this shift is the amount of time it takes to gain protocol approval in academic settings: the initial approval process prior to initiation can take from two to six months in an AMC, compared with one to two months in a private hospital or less than one month in a physician’s practice.
"In an industry where speed is paramount, and where for each day’s delay in gaining FDA approval of a drug the manufacturer loses and average of $1.3 million, such delays are problematic, at best. There has also been a trend in recent years for US pharmaceutical companies to conduct clinical trials outside the US. For example, the number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500, but with less research being done at U.S. sites."
The background paper also reported:
"Given the newness, uncertainties, and challenges associated with cell-based licensing by the pharmaceutical industry or investment by the venture capital community) is unlikely to be available for such therapies until there is proof of clinical concept; until methods to consistently produce cells are developed; and until the related business models becomes more accepted. This will likely limit the ability of smaller companies to move promising therapeutic approaches into clinical trials and eventually to patients without additional sources of funding."
