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Clinical trials flourish in international setting

Clinical trials flourish in international setting

ABSTRACT: Europe is firmly established as a trial venue, while the Asia-Pacific region is gaining ground thanks in part to efficient trial systems and rapid recruitment.

A call center in India takes a customer service inquiry from Idaho; an Australian doctor reads an emergency x-ray for a U.S. patient; a professor in Moscow delivers a lecture via satellite to UK-based students—these examples of “going global” no longer seem so novel. Cancer clinical trials are also crossing international datelines. Between 2005 and 2006, international clinical trials initiated in the Asia-Pacific region increased by 50%, while major research initiatives—once the stronghold of U.S. institutions—are now run by EU-based investigators.

Globalization isn’t the only reason that trials have shifted to other countries. Increasingly, U.S. cancer trials are fraught with problems, including a bureaucracy that eats up research time and a reluctant patient pool (see Table on page 12).

At ASCO 2009 in Orlando, ASCO and ESMO will hold a joint symposium, “Global Clinical Trials—Challenges and Solutions,” to identify global issues in clinical trial accrual, data sharing, and trial design. The June 1 special session will be cochaired by ASCO president Richard Schilsky, MD, of the University of Chicago and ESMO president Jose Baselga, MD, of Vall d’Hebron University in Barcelona.

“We felt this (symposium) was really becoming necessary because of the increasing number of global trial protocols,” Dr. Baselga told Oncology News International.

Dr. Baselga, along with other experts, talked with Oncology News International about the rationale behind international clinical trials and why, in many instances, our colleagues overseas do it better.

Making trial enrollment the rule
The ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study will randomize 8,000 patients from 49 countries and 1,300 sites and look at the efficacy of combining two anti-HER2 agents. Due to extremely high interest in the research question, the study is accruing rapidly, Dr. Baselga reported.

ALTTO is organized by the European-based Breast International Group (BIG), which consists of a network of 44 collaborative groups, research partnerships, and trial units from Europe, Canada, Latin America, and the Asia-Pacific region. BIG recently forged ties with NCI and the National Surgical Adjuvant Breast and Bowel Project.

While the North Central Cancer Treatment Group in the U.S. is co-coordinating ALTTO, it will contribute only a minor proportion of patients: just one for every 40 recruited from other regions, according to Dr. Baselga. The imbalance in the ALTTO patient enrollment reflects a major difference between U.S. and European trials: Both European patients and physicians are more open to trials.

“Outside of the United States, patients often have better access to therapies within clinical trials. In fact, sometimes they cannot get the best treatment without it,” Dr. Baselga said. “In my department, 20% of our breast cancer patients are enrolled in trials. We assess every patient in a committee before we determine treatment, and we see if she is eligible for a trial. It is expected.”

Michael Gnant, MD, of the Austrian Breast and Colon Study Group (ABCSG) echoed that statement, explaining that the majority of patients in his country are enrolled in trials.

“The high enrollment in our trials is the result of a group of scientists and physicians working together for more than 20 years,” Dr. Gnant said. “In Austria, many are convinced that clinical trials ensure treatment quality for patients. We have numerous communication activities aimed at doctors, patients, advocacy groups, and the media. Scientifically, we feel this is the best chance for a small country to be successful on a global stage.”

The ABCSG tries to make trial enrollment simple for patients and physicians. “We have a web-based randomization and documentation system, and we have monitors and data managers who try to take the bureaucratic burden away from the individual oncologist,” he said.

Quicker turnaround
An investigation done at the Center for Management Research at Nashville’s Vanderbilt University found that it required nearly 2.5 years to design and open a clinical trial in the United States (J Clin Oncol 24:4553-4557, 2006).

That’s hardly the case in other countries, according to David Kerr, MD, president-elect of ESMO and Rhodes Professor of Clinical Pharmacology and Cancer Therapeutics at Oxford University. Dr. Kerr is heavily involved in global trials conducted in Spain, Austria, France, Australia, and several Eastern European countries.

“With our international collaborations there are always complexities around the start-up, but once they are up and running, they go well, . . . usually, the time from developing the protocol to the first enrollment is about one year,” he said.

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