Comprehensive review of US's clinical trials system needed

An editorial in Nature by Arthur Ammann points out a number of problems with our current clinical trial system:

Inadequate expertise: the composition of IRBs has not kept pace with the complexities of ethics and science. Expert opinions are often derived from individuals who lack sufficient expertise to make an informed decision.

Conflicts of interest: individual IRB members may gain salary, health and retirement benefits from approval of research studies conducted at their institutions, which may also make gains.

Exclusivity issues: the design and ethical review of federally funded research is often undertaken by a homogeneous group of individuals with congruent interests at the same or similar academic institutions. Individuals from the public, advocacy groups and non-academic organizations are often excluded…

Marked increases in funding: the NIH budget for research in 2011 was more than US$30 billion. Large amounts of money can distort priorities for research and shift the focus away from urgent public-health needs on the basis of the belief that all research products merit clinical evaluation. The number of products in the therapeutic pipeline is rising and there is noinformed method for prioritizing those which should move into clinical research. This increases the risk for people who participate in research.

Increased cost of clinical research and fewer treatment-naive individuals… in the United States: the number of research participants required to obtain statistically significant results for new products has increased drastically because of the need to compare these products with ones that are known to work. A ‘mining’ approach to obtaining treatment-naive people for research in poor countries has evolved, enlisting vulnerable populations… The shift to resource-poor countries is often accomplished by reducing standard of care, exaggerating potential benefits, the use of inferior treatment comparisons and the enrolment of vulnerable people not fully informed of their legal or ethical rights.