Cardiovascular Clinical Trials The Paradigm Shift Of Drug Development

Below we take a look at the magnitude of the problems faced by the cardiovascular

clinical trials arena and how it relates to interaction between pharmaceutical companies and contract research organisations (CROs).

The fact that there are already numerous effective drugs for cardiovascular disease on the market, alongside the fact that new drugs must now mostly be assessed on clinical rather than surrogate endpoints, makes it very difficult to laud the potential benefits that a new drug might have. This is compounded by the contentious issue of using placebo-based clinical trials. Although there is an inchoate consensus over the justifiable use of placebos, many people still disagree over using them in lieu of active pharmaceuticals.

The difficulty comes when there is mounting pressure for the drug development industry to replace current treatments with ones of equivalent efficacy but with a lower cost.

Against this backdrop of difficulty comes an incredible range of new therapeutic elements including proteomics, genomics and combinatorial chemistry that will add to the complexity of drug development costs. These new practices will add even more layers of intricacy to the research and development (R&D) budgets of pharmaceutical companies. All of this impacts the current preoccupation of the drug development industry reducing the timeframe between getting a compound to market and peak sales. It is this driver factor, multiplied by inflation and greater regulatory demands, which is leading pharmaceutical companies to outsource a large proportion of their R&D to CROs.

Increasing and managing IP to achieve a greater number of leads

Pharmaceutical companies need to maximise the number of promising compounds they have in the pipeline of their R&D departments. More promising compounds mean more promising leads. More promising leads mean a potentially greater number of valuable assets going to market.

In this effort, pharmaceutical companies can find that they have acquired too much IP to deal with in-house or it is simply more cost-effective to outsource to a CRO that is specialised in the process of screening for the promising compounds rather than trying to develop the specific methodologies and the staff to facilitate them in-house.

The drivers are similar when the compounds are taken through the clinical trial phases. CROs may have access to certain technology or expertise that is cheaper to utilize than to develop in-house.

Outsourcing provides the dual benefits of reduced cost and timescales that aligns directly with a pharmaceutical companys need to get valuable assets from the screening process to peak market sales as quickly as possible.

by: Stefan Ferguson

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