Entering the millennium the Pharmaceutical Industry will continue to rank among the largest grossing industries in part due to the rising demand for innovative Healthcare across all therapeutic areas. Essential to the growth of Pharmaceuticals is drug discovery and drug testing. Multinational drug companies and global contract research organizations (CROs) depend on trial investigators to provide the critical link for accessing patients and data. Of course, it is high quality patient data that will ultimately determine the success of a clinical trial, and the subsequent marketing and sales of pharmaceuticals. Working collectively, clinical trial investigators can play a greater role in healthcare advancement by organizing into research consortia.
The New Trend:
Research Consortia are changing the clinical trial landscape and lucrative variations have emerged in several countries including Canada, United Kingdom, Australia and the United States. Trialists and Industry are realizing the mutual economic and research benefits of working with Consortia.
Consortia enable physicians to deal more efficiently and effectively with industry by bringing the R&D market to the physicians and the physicians to the marketplace. The secret to success is two fold: Consortia must be managed as a business and develop their academic profile.
The emergence and implementation of ICH Guidelines is a testament to the increased level of sophistication required in the clinical trial arena. ICH Guidelines are an "enabler" for the coordinated internationally harmonized development of test drugs (to avoid repetitiveness, redundant measures etc). Their subsequent registration and licensing can be approached in an expedited, regulated and non-redundant manner. These measures are complementary to research consortia entering competitively into international clinical trials.
In brief, drugs that dont work are discontinued more quickly, saving time and money. Consortia employing the expedited review (of test drugs) can evaluate drugs efficiently and objectively to assess whether commitments should be made to the clinical development of research compounds. Furthermore industry analysts predict an accelerated rate of growth in the pharmaceutical industry due to faster product take offs, reduced market exclusivity times, and the quicker introduction of copy cat drugs and generics. One emerging strategy is for pharmaceutical companies to place drug candidates on global drug development and launch programs to achieve a worldwide effect in sales.
Nations like Australia, Canada, U.S., Japan, the UK and many EU countries excel in clinical trial performance. Proven local expertise in clinical trials over past decades as well as developed regulatory agencies and government programs that foster clinical trial activity drives their achievements. In addition, these regions are politically stable, achieve economic growth, increase healthcare expenditures, institute patent protection, have good literacy levels and better informed patient populations. Together, these circumstances yield the right habitat for the successful emergence of consortia.
Given the new opportunities emerging from the changing R& D landscape research Consortia are poised to tackle exciting challenges in new frontiers. Patty Djan Inc. is a truly unique, progressive and innovative company where clients are enabled to become successful