Tuesday, November 5, 2013

Which Factors Influence the Rising Costs of Clinical Trials?

Recent trends suggest a rising costs in conducting a clinical trial, a trend that seems to hinder the discovery and development of new medicines. This could be disturbing news for various pharmaceutical companies and patients expecting newer health drugs.

A study conducted by the Tuft Center for the Study of Drug Development stated that drug costs increase about 5 times faster than preclinical costs during the 1980s to 1990s. Present day estimates suggest that clinical research trials costs feature at 1.3 billion US $ to 1.7 billion US $.

There is widespread debate about the increase in trial costs. Reducing trial costs is absolutely essential for the greater good of the common man. It is estimated that drug costs have increases at a rate that was 7.4 % higher than inflation over the previous 20 years (Ann Neurol 2007;62[6]:A6-7).

Some attribute the rise in costs to the industry's success over a couple of years. The research and development of these new drugs has made it very difficult for pharmaceutical companies to prove that their products are superior to pharmaceutical products that are presently available in the market.

Pharmaceutical companies see the pressing need to gather more data to show modest benefits over their competitors resulting in more recruitment for clinical trials. The need to search for innovative new products has pushed companies to develop treatments for chronic health conditions. However, the clinical trials for these types of drugs tend to be very expensive, long and complex. Other factors influencing drug costs are development of clinical trial protocol, more emphasis on site monitoring, increase use of imaging technologies and different interpretation of compliance regulations.

This increased cost if affecting the pharmaceutical industry in many ways. Most companies are conducting clinical trials in countries such as India and China, where costs are about 60% lower. The industry is more cautious than before and is not willing to take chances with novel medicines.

In an effort to minimize costs, pharmaceutical companies off load their research and development responsibilities to Contract Research Organizations (CROs). Organizations now seek to eliminate inefficiencies in the clinical trial process by streamlining it. International Conference on Harmonization has played a major role in harmonizing regulatory requirements across all major drug markets.

Reducing the failure that is associated with the later stages of the drug trial process, one can reduce the costs associated with the trial. By improvising the process of successful review at critical end-points of a clinical trial, weeding out failed subjects in the earlier stages would make it cost effective during phase 3 trials. Also, electronic data capture seems to offer a better alternative for improving the data quality.

However, there is still no denying that clinical research offers the best and most reliable solution for the discovery and development of new drugs.

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