So a few days back I wrote an article regarding what sponsorship means as it pertains to the world of clinical trials. I decided to do a video on this topic today and have included it here. Hope it answers some of your questions that I have been getting lately.
Industry sponsorship of biomedical research may come from biotechnology firms, pharmaceutical companies and/or medical device firms. The majority of clinical trials conducted worldwide are paid for by the pharmaceutical companies that are trying to develop, and get approved, new drugs, devices or medical procedures. In fact, approximately 70% of clinical trial funding in the United States comes from industry. It is upon this foundation that the entire, multi-billion dollar private clinical research industry has been built. The general idea under this model is that the pharmaceutical company wants (and needs) to continuously get new products out to market. In order to accomplish this, they need FDA approval for their new products. The FDA, in turn, needs to ensure that the products are safe, efficacious and provide new types of benefits for the end user of the products.
What the reader must understand are the costs of producing a new investigational product and its financing all the way through FDA approval or rejection. According to NIH Director Dr. Francis S. Collins, “[t]he average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after adjusting for all of the failures.” Furthermore, quoting the Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary, “costs linked to failed experimental drugs account for three-quarters of the cumulative drug development costs (DiMasi et al., 2003; Parexel International Corporation, 2008).” Taking a slightly different perspective, “[m]ore than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models.” Adding to the costs is the time it takes to get an investigational product from pre-clinical development through the various phases of clinical trials (phases 1 – 4). When everything is taken into account, it is not unusual for an investigational product to spend ten years in clinical trials before it is ready to receive FDA approval or rejection.
There are other types of funding mechanisms for trials: clinical trials that are federally funded, state and local government funded or those which are conducted at academic institutions that are co-sponsored by pharmaceutical companies but still federally funded. The idea behind federally funded medical research is that the government will allocate public funding in order to pursue research in order to develop medication that otherwise may not interest large pharmaceutical companies, especially those with investors to answer to, to allocate money towards funding expensive clinical trials.
As Pharmaceutical companies begin to look towards China for not only their outsourcing destination of choice but also as the place of their future customers, they are beginning to shed some light on how the drug development landscape might look like going forward in the very near future. As I wrote about a few weeks ago, many drug companies are not just outsourcing their work to Chinese CRO’s as they have done in the past in different countries, they are partnering with them and these long term partnerships mean sharing profits and co-developing drugs specifically for the Chinese market. Some US CRO’s are also making strategic partnerships with Chinese companies as they can develop specific industry knowledge regarding the Chinese regulatory system. Time will tell as to how lucrative these partnerships will become for Big Pharma, but it is clearly evident that China will be the next area of focus for drug development and commercialization as the US drug pipelines are drying up due to patent expirations. Look for more stories on China in the future.
Today’s video is a direct response to a viewer’s question regarding what a regulatory job in clinical trials would entail, how to land one of these gigs, and what the starting salaries are. I did my best to answer this question with some of my personal experiences in this industry. While this information is anecdotal, I believe it is relatively accurate in regards to regulatory functions and clinical research.
If the FDA (Food and Drug Administration) has been looking at any one thing in particular when doing their audits lately, it has been PI (Principal Investigator) oversight, or the lack thereof. Essentially when a PI signs a 1572 form that gets filed with the FDA, he/she makes a commitment to supervise the study as per Good Clinical Practice. Part of this supervision entails actually supervising the study and being aware of what is going on with the studies that he/she is conducting. This does not mean tat the PI cannot delegate certain tasks to the research team, but the source documentation must, at some point, show some of the PI’s footprint such as progress notes, signatures on lab results, ECG reviews, etc. I have heard of many sites getting audited specifically because the FDA felt that there may not have been enough oversight at the clinics.
Darshan Kulkarni from Kulkarni Law Firm came on the show today to shed some light of the recent Wellbutrin generic scandal in which the generic equivalent of the 300mg premium drug was not equally effective as the 150mg generic compared to its respective counterpart. In this interview we discussed what this may mean for clinical trials going forward, particularly the way generic clinical trials may be handled in the future as they will be closely watched by the FDA.