ACRO Reports that Clinical Research in Developing Worlds is Up to U.S. Standards

Pharmaceutical Online reports that the Association of Clinical Research Organizations (ACRO) has released a report that says clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. Based on the report's findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.

With the changing landscape for CROs, the report has several key findings:

• Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three times as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
• Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
• Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
• Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

For more information about this report and about ACRO, please visit the article referenced here.

Clinical Research Safety And Ethical Standards In Developing World Up To U.S. Levels

Changing Face of CRO's

As we remarked upon earlier on this blog post, Covance Inc. entered a deal with Eli Lilly and Co. to purchase Greenfield Laboratories in Indiana for $50 million, while also entering a contract research deal for $1.6 billion. This new business model for Contract Research Organization and Drug companies was recently discussed in this article from redOrbit. As the article quotes:

"The Covance deal represents the next phase," says Douglas Peddicord, executive director of the Association of Clinical Research Organizations in Washington, D.C. "It marks a move from a contract research organization providing outsourced, disintegrated services to one where it is in fact going to be a strategic partner in Eli Lilly's drug development work."

The article further quotes Peddicord as saying:

"Development projects that used a higher degree of clinical research outsourcing got to the finish line, as in submitting a new drug application to the FDA [Food and Drug Administration], 30 days faster than others without any diminishing in quality,"

It will be interesting to see if more and more companies will reach similar agreements if the Covance/Eli Lilly deal prove fruitfull.

ACRO Accepts New Members

As reported in market watch, the Association of Clinical Research Organizations (ACRO), has accepted two more members, Clinilabs, and RPS. Clinilabs specializes in dealing with the central nervous system and cardiovascular therapeutics. RPS, provides global Phase I-IV clinical development solutions.

David Spaight, ACRO Chair and President, released this statement:

"I am extremely pleased to welcome Clinilabs and RPS as new members of ACRO. Their involvement will enhance the association's ability to represent the CRO industry broadly to government officials, research sponsors, patient groups, and others international stakeholders. We invite all CROs to consider membership in our industry's trade association."