CONTEXTS

Applied TheoryWriting for the Participants of International Clinical Trialsparticipants for clinical studies, and fewer participantsfinish the trials than in other countries (Malakoff,2008). Offering payment to participants of clinicaltrials is equally unacceptable throughout the world; still,it is easier to recruit patients in developing countries(Lustgarten, 2005).Medical and Legal Reasons for OffshoringPatients in developing countries typically are “naïve.”Previous treatment may confound the results ofclinical studies, but naïve patients have not receivedcare for their diseases and conditions (Mitchell, 2008).In addition, the large pool of recruitable subjectsin many developing countries offers many genomevariations and allows the investigators to studydifferent ethnic responses to the experimental drugs.The FDA urges that clinical studies be conductedon ethnically diverse populations, since such testingcan provide an understanding of how medicationsaffect various groups. In fact, if a trial is conductedwithin a single ethnic group, the FDA requires anadditional study (Mitchell, 2008). Conducting studies inseveral countries simultaneously helps fulfill this FDArequirement.Because of the boom in offshore clinical trials,international health organizations have had to developstandardized regulations and guidelines. Bailey,Cruickshank, and Sharma (2006) contend that theseregulations and guidelines, together with strongerintellectual property protection in developing countries,are contributing to the globalization of clinical research.However, clinical trials in developing countries arestill a rather new concept. These countries haveunderdeveloped legal regulations for trials, a situationthat attracts pharmaceutical companies that see anopportunity to avoid extra steps in bringing newmedications to market. In addition, pharmaceuticalcompanies strive to enter new markets that are verylarge and rapidly growing, such as those in India, China,and Russia. Thus, many companies are testing notonly drugs for worldwide use but also region-specificmedications.Offshoring to RussiaAlthough the clinical trial market is growing in Chinaand India, Russia is still one of the world leaders inpatient enrollment (Business Insights, 2009). Accordingto a comprehensive market report published in June2009 by Synergy Research Group (SynRG), a Russianbasedclinical research organization, even in thecurrent global economic crisis the market for clinicaltrials in Russia is growing (Ward, 2009). A Russianonline newspaper that provides legal informationand advice—Moscow Pharmacies (Московскиеаптеки)—reported that between 2000 and 2005, 2,015clinical studies were approved in Russia, 50% of whichwere international (i.e., sponsored by non-Russiancompanies). Most of the international studies testedoriginal, new medications, while the Russian studiesevaluated the bioequivalence of generic drugs.In the past decade, the Russian Federation hasbecome one of the primary locations for U.S. medicaltesting. U.S. pharmaceutical companies are drawn toRussia for clinical trials because of the country’s diversepopulation, still-developing legal system, and overalllack of domestically produced medications. Russiais a large market for medications, and Russian lawprohibits importing medications without testing themin the country. In addition, Russia has a centralizedhospital system, which makes the process of recruitingparticipants relatively cheap and fast. The medical systemis not in good shape and average incomes are not high,so trials often are not a choice but a necessity for patientswith few treatment alternatives. Moreover, participants aregenerally “naïve,” and their diseases are often advanced;the combination of these two factors provides a perfectbaseline for scientific study. And finally, doctors whobecome investigators in clinical trials can make 10 timestheir usual salary by recruiting patients (Lustgarten, 2005).As a world leader in patient enrollment in clinicaltrials, Russia can serve as a comprehensive examplefor exploring the characteristics of informed consentdocumentation in the international arena. Anecdotalevidence suggests that most of this documentation iswritten by technical writers in the United States and thentranslated into Russian. By understanding the legal andmedical systems and the economic situation in Russia,technical writers can better anticipate the informationalneeds of the participants of clinical trials and thuscomplete their tasks more effectively.270 Technical Communication l Volume 57, Number 3, August 2010