In an ideal circumstance, an FDA expert would need a combined experience of medicine, medical law, pharmacology, medical research, experience in clinical trials and experience within the pharmaceutical industry as well as clinical experience, and optimal experience at the FDA.
Of these supremely rare individuals, there are untold numbers of specialties and sub-specialties. Of those remaining individuals, not all can produce high-quality published research results.
There are 141 accredited medical schools in the United States, each graduating around 100 students per year. Approximately 10% of students pursue and complete the MD/Ph.D. course, and of those, very few MD/PhDs end up doing full-time, or even part-time, research. In the age of litigation and insurance companies and a contracting research economy, being and maintaining one’s status as a clinician has become extraordinarily demanding, and doing meaningful research requires a significant time commitment.
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Because of these factors, many of the MD/PhDs who do full-time or part-time research are dumping their research obligations due to a combined lack of research grants, research progress, and time.
Complicating the lack of scientists, drug development has become more challenging than ever. Due to increased federal regulation by the FDA, drug makers are spending more and working harder to advance their research and replenish their pipelines.
Along with encountering increased regulation, drug manufacturers are contending with the issue of the rising costs for all phases of clinical trials.
There is increasing competition for trial sites and clinical research organizations that can yield reliable high quality data.
Contract Research Organizations (CROs) have had to increase their enrollment fees.
According to 2012 market research data from Cutting Edge Information the average per-patient trial costs increased across all therapeutic areas.
In Phase I, costs rose from $15,023 in 2008 to $21,883 in 2011. In Phase II, the cost rose from $21,009 to $36,070. In Phase IIIa, the cost increased from $25,280 to $47,523 and in Phase IIIb, cost jumped from $25,707 to $47,095.
Finally, Phase IV expenses rose from $13,011 to $17.042. This includes higher costs for enrolling patients and higher vendor fees for managing the increased technology mandated by the FDA needed to manage and analyze the increased volume of data associated with drug development.
According to additional market research data from Cutting Edge Information, the recent average cost per patient for a cardiovascular trial in Phase IIIa was $21,750 and $6,830 in Phase IIIb.
The cost for Phase II was $33,700. In oncology, the average per patient trial cost for Phase IIIa was $57,207 and $65,900 for Phase IIIb.
For Phase II, the average cost was $73,303. For a drug to treat central nervous system disorders, Phase IIIb costs were $41,824 and Phase IIIa costs were $33,768, on average per patient. Phase II was $28,197.
And for diabetes, Phase IIIb costs were $10,700, Phase IIIa costs were $12,667 and Phase II costs were $8,854.
Importance of an FDA Expert
With this, efficiency while producing high-quality results becomes of paramount importance and, therefore, the input from an experienced FDA expert can be critical.
An FDA expert can be of critical importance in assisting in controlling increased costs associated with all phases of clinical development assuring that clinical research is conducted efficiently and of the best quality.
Clinical trial design and clinical protocol development, which includes sample analysis, and monitoring personnel is inherently a very wasteful process if not composed in a streamlined and efficient manner.