Evolving Clinical Trials - Pharmaceutical Executive

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Evolving Clinical Trials
The process of developing drugs needs to change. A recent survey shows that tackling problems with the underlying clinical trial supply chain could help industry reach the next stage of efficiency

Pharmaceutical Executive


Clinical trials today cost more money, are more complex to manage, and take more time to conduct than ever before. And, going forward, executives predict a lot "more" of everything: more clinical trials, adaptive trials, regulations, geographies in which to conduct trials, and outsourcing partners.


Geographic spread of clinical trials
All of these changes are needed to maintain global competitiveness. The key to their orchestration, however, lies in an efficient clinical trial supply chain (CTSC) that provides on-time delivery of supplies, with shorter lead times, and at an optimal cost. A recent survey showed that the area was ripe for investment, with executives predicting a 400 percent increase in spending from 2006 to 2010, to $60 million per company.


Current Clinical trial supply chain process
To understand how these changes will unfold, BearingPoint and AMR Research conducted 107 Web-based, quantitative interviews from October to November 2007, as well as follow-up, one-on-one interviews with 11 executives in global life sciences companies. Fifty-five percent of those surveyed came from pharma, and 45 percent from biotech; multiple geographies were represented, including the US, UK, France, Germany, and Switzerland. Almost all (94 percent) of the respondents have a formal CTSC process.


Investment Initiatives—Today and Tomorrow
The research revealed that most companies are focused on recruiting and retaining top managers and scientists, as well as speeding time to market for new drugs. But when asked to look forward to 2010, the executives said the focus would shift toward improving efficiencies. This included expanding current efforts to accelerate drug development, as well as initiatives to manage global supplies through multiple partners and reducing costs. (See "Investment Initiatives—Today and Tomorrow".)

Bigger, more globalized trials Survey respondents reported a sharp increase in clinical studies they plan to conduct. In fact, nearly 20 percent projected a 400 percent increase in the number of trials performed, while 30 percent expect that the length of studies will increase in the 2007 to 2010 time frame.


Major challenges/barriers in conducting adaptive trials
Companies also expect to administer more clinical trials outside their home geographies, particularly in Eastern Europe, Africa, and India. (See "Geographic Spread of Clinical Trials".) With growing globalization, top challenges include managing legal and regulatory requirements, followed by establishing global operating procedures. European firms perceived regulatory requirements as more challenging, while US firms cited globalizing operating procedures as the more difficult task.


Supply Chain Challenges
Adaptive trials Adaptive trials are on the increase, especially among US companies. (See "Major Challenges/Barriers".) These studies can speed development, but can stress the CTSC because, with more decision points throughout the trial, demand for supplies can change rapidly.


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