Apr 30

Patient recruitment, retention and emerging makets

Emerging markets Comments Off on Patient recruitment, retention and emerging makets

Clinical trials are essential part of new drug and medical device development.

For one million of molecules, only a thousand will be selected for further research, and of them, only one will become a commercialized drug. The cost of development for each marketed drug is estimated to 1 billion dollars. A patent for a new drug is good for 20 years, but also include clinical trials phase I to III. From clinical trial phase I day 1 to the day it is approved by the FDA, Health Canada or other federal organizations and marketed, it usually takes about 10 years. But to those 10 years, another 3 years is needed to pay back the cost of development of the molecule, leaving only 7 years to make this new molecule profitable. With the quick apparition of generic molecules, pharma companies need to keep their price low to remain in the competition. And with today’s competition, this time laps is even shorter. The internationalization of the pharma industry and the merge of more and more phama into giants are also an imminent threat to the profitability of new molecules, therefore the survival of many pharma.

This is why delay and costs in operations will drive in what countries clinical trials will be conducted Delays in operation means a reduce efficiency, leading to million of dollars losses due to missed market opportunities for potential blockbusters. Often, those delays can often be explained by difficulties in recruitment and patient retention.

Once leaders in clinical trials, Europe, U.S., Japan and Canada are now losing quickly to emerging markets such as India, China, Eastern Europe and Brazil. While the number of clinical trials have reduced in Western Europe, U.S. and Canada, there has been a strong increase in the new markets. Recent reports have shown that the number of clinical trials conducted in Eastern Europe has tripled in only 5 years, and that the cost in those countries was easily cut in two.

The “Patient Recruitment and Retention in Clinical Trials” report was released by the Busines Insights.

The report states that:

– as much as 50% of trial delays are caused by lack of patient recruitment, leading to over $500,000 in lost sales and resulting in losses of over $8m for blockbusters.
– there are under utilized tools in the US, Europe and Japan, such as the Internet
– there is a migration from the U.S. and Western Europe to offshore locations that are cheaper. As a matter of fact, leaders, such as GSK, Pfizer, Roche and Norvatis, all have an established presence in India, China and Eastern Europe
– there is an under-investigation effects in women, and in the U.S. and the EU, women are under-represented in clinical trials.

In order to keep clinical trials to come back, industrialized countries need to increase patient recruitment and retention in order to compete with the emergent makets.

For more information, visit Clinical Trials.

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