Navigating patient recruitment on global stage	May 2009

By Michael Christel

Motivated further by today’s tenuous economic environment, international drug developers, seeking the benefits of faster patient recruitment and other clinical-trial cost savings, are increasingly migrating oversees to test their products.

Countries like India, China, and Russia, dubbed by many as emerging superpowers of clinical research, offer several advantages for pharmaceutical sponsors, most notably access to large pools of treatment-naïve patients with both first and third-world diseases. While significant regulatory, ethical, and cultural challenges exist in these locations as well, the expansion of medical research into regions such as Asia Pacific, Eastern Europe, and South America is clearly evident.

As the clinical research landscape continues to widen, so do the business challenges for contract research organizations and patient recruitment providers. These companies, now more than ever, must be capable of developing and managing recruitment programs on a global scale, with strategies that meet each local site’s needs, in whatever country they are located.

According to Donna Beasley, VP of operation for Praxis, a patient recruitment provider, expanding the geographic boundaries of coordinated study enrollment adds several variables to consider into the mix. These include regulatory guidelines; ethics boards; review and approval times; logistics; cultural variances; acceptability and appropriateness of tactics; and native language interpretation.

“But the fundamentals remain the same, know your patient population and how best to communicate with them,” Ms. Beasley says.   

Diana Anderson, Ph.D., president and CEO of patient recruitment and retention firm D. Anderson & Company, has authored three books on international patient recruitment guidelines and is a frequent speaker on the subject at conferences around the world. Her company has experience in 62 countries and expertise in more than 40 therapeutic areas.

“Patient recruitment providers must adapt to and embrace these emerging regions,” Dr. Anderson says. “Patient recruitment providers involved in global studies need to proactively work to understand cultural differences, the patients’ daily lives, and the local medical systems to create recruitment programs that are both suitable and impactful. Furthermore, the patient recruitment provider must confer with the sponsor, country-level study teams and local [clinical research associates] to ensure sites understand the recruitment support available to them.”

According to Dr. Anderson, in 2008, 48% of D. Anderson & Company’s business was internationally focused, up from 40% in the previous year. She says so far in 2009, half of the company’s new contracts are for global programs.

Many patient recruitment organizations are taking advantage of new opportunities outside of the United States. Late last year, California-based Healthcare Communications Group opened up new offices in London and Singapore. Along with North America, the company now supports clinical enrollment in Brazil, Russia, India, China, Latin America, Asia, the Middle East, Central and Eastern Europe, and Western Europe.

“As we expand into those areas, there are issues of IP and other data transmission, GCP [good clinical practice] challenges, and, finally, genotype issues having to do with the strength of the [the country’s] respective dosing amounts of different compounds,” Mr. Kilpatrick says. “The business climate is really changing in those areas, but it’s not without a certain amount of nuance that we are helping sponsors expand into those areas. The smaller companies need our help because they haven’t done trials ex-U.S. and they don’t know all the things to look for.”

Sponsors continue to rely on the geographic scale of CROs, many of which have operations in these emerging clinical markets. When it comes to patient recruitment and the associated regulatory and cultural factors, Joshua Schultz VP, clinical research services, Parexel, says it is critical for CROs to have staff “on the ground” in the relevant countries. Parexel has a presence in more than 50 countries.

“Guidelines for ethics committees may appear similar at a country level but may vary greatly within the country or between individual ethics committees/institutional review boards,” Mr. Schultz says. “In addition, given the varying timelines and recruitment rates associated with global studies, the use of modeling tools and recruitment strategists is necessary to planning and managing a successful campaign.”

From a business standpoint, Janet Jones, Ph.D., senior director, project information & feasibility, at Icon Clinical Research, says when assessing global trials, it is important to balance the goals of cost effective delivery with the commercial needs of the sponsor.

“While emerging regions are strong for treatment-naïve patient studies, the diversity of the regions allows us to find the specific patient populations for many protocols,” Dr. Jones says.  “Consequently, well-planned global trials offer the greatest cost effectiveness when the optimal country distribution is identified.  Furthermore, sites are motivated to participate in leading-edge research and want to get the best treatment options for their patients.  With the strong physician-patient relationship, patients are eager to gain access to modern diagnostic procedures, medicines, and care.”

Not all U.S.-based clinical-trial service providers are sold on the strategy that moving more studies offshore delivers a better return on investment. Gail Adinamis, president and CEO of Clinical Resource Network, believes it is more cost-effective to conduct studies in the United States rather than set up trials internationally. Clinical Resource Network, using a network of over 3,500 licensed and accredited home healthcare agencies, provides and coordinates select in-home protocol visits, essentially bringing the clinical trial to the patient.

“What’s happening is people are thinking there’s too much competition in the U.S., there’s more patients in these other countries, and the costs are going to be cheaper in the other countries,” Ms. Adinamis says. “Well, guess what? Everybody’s jumped on the bandwagon and it’s a supply/demand. The costs, which used to be really cheap, have now gone up 25 to 30%.”

According to Ms. Adinamis, investing in global trials does not merely require looking at what the investigator grant cost is going to be, but rather the price tag for setting up an entire study, which are traditionally heavily influenced by the respective legal hurdles in each country. She also says investigators, realizing that the cost for their services globally is worth significantly more than in the past, are increasing their rates.

According to Ms. Adinamis, Clinical Resource Network is presently coordinating services in Australia and is also exploring requests for business in Latin America. Nevertheless, she believes that there remains a significant untapped clinical-trial patient population in the United States, one that could be harnessed, she says, if companies and sponsors simply made it more convenient and comfortable for individuals to participate.

“We’ve got a lot of patients here,” Ms. Adinamis says. “It’s just a matter of looking under another rock here in the states.”