CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Irina Petrova, M.D., director of Clinical Operations at OCT, a full-service CRO based in Russia that also operates in Europe and the U.S.
Q: Russia has become a popular location for clinical research, in part, because its centralized healthcare infrastructure allows for rapid patient recruitment and retention. What are some of the methods or processes that OCT uses to successfully recruit patients for its clinical trials?
A: In one example, we participated in a multicenter phase III respiratory infection trial to investigate the efficacy and safety of a drug in the form of a dose spray compared to the same drug in lozenge form. A total sample size of 440 randomized patients was required for the study. Trials with over-the-counter medications for indications such as the common cold or sore throat are always a challenge to recruit because patients are not motivated to participate. They do not see any benefits compared to the inconveniences caused by research studies. During cold season, there might be hundreds of potentially eligible patients with sore throats, but none of them would agree to be included in a clinical research study.
The key to successful recruitment was the right choice of investigative sites. It is important when selecting a site to discuss with investigators how they will motivate subjects, the consent process, recruitment procedures, experience in similar clinical trials and their resource capabilities. Can they maintain a high recruitment speed throughout the cold season without compromising the quality of their work?
Another important factor was close contact between CRAs and investigative sites. CRAs provided every possible assistance to the sites so that they felt supported and were eager to enroll more subjects. We also assigned a project manager for each project. Our project managers all have at least five years of clinical experience and their educational backgrounds range from biologists to medical doctors. Their strong monitoring skills allowed them to predict problems, analyze trends and develop solutions for problems. We established a referral network as a contingency plan for this study, but due to the high recruitment rate, the plan was not implemented.
It was expected to take 18 months, or two cold seasons, to recruit the required number of patients. OCT managed to finish the enrollment in less than 12 months. A total of 15 investigational sites were initiated for the trial, with approximately 27 patients enrolled per site. Moreover, the drop-out rate was only about 3%. The OCT team managed to achieve a 30% reduction in enrollment duration and improved the overall efficiency of the trial.
Usually, such rapid enrollment rates are associated with quality-related risks and delays in data collection. OCT eliminated these risks by developing a strategy in advance that allowed for quality control of investigator activities and an adequate data-recording schedule.
Q: Recent legislative changes have reduced the bureaucratic requirements for conducting clinical trials in Russia. Have you seen an increase in demand for local CRO services as a result?
A: We expect to see an increasing number of international studies in Russia due to the recent legislative changes, which were aimed at harmonizing the local regulatory requirements with international standards. Our company has seen requests for clinical trial projects double. The changes have also heightened interest among pharmaceutical market players in assessing drug interchangeability. According to an Association of Clinical Trials report, the Ministry of Healthcare approved the start of 450 clinical trials in the first half of this year, which is almost 30% higher than the same period last year.
It’s cheaper to conduct a clinical trial here, compared to Europe and the U.S., and our region still has a large pool of treatment-naïve patients. With vast and easy-to-access populations and top-grade research facilities, Russia has become an attractive region for phase III clinical trials.
Healthcare systems differ from country to country. Clinical trials reflect the local aspects of healthcare regulation, special features of an investigator’s work and patient behavior. We understand the way of thinking for all parties involved in the process. In addition, for a CRO, the quality of managing all the processes depends on the number of completed trials. Only experience can teach you what actions are right in each situation.
Q: What is the general public perception of clinical trials in Russia and the level of willingness to participate in research?
A: Clinical trials aren’t a topic for discussion in society and the media very often. The Russian public is not very familiar with clinical studies. But in recent years, interest in the biotech industry has increased, which will hopefully be followed by people’s readiness to learn more about this important stage of drug development.
We see our mission as developing the industry by providing the best clinical trial services for sponsors who are interested in educating society more about clinical trials. Annually, we arrange a conference called “Clinical Trials In and Outside Russia,” where 300 industry professionals discuss their current challenges. We believe that, with such events, we make an important contribution to the industry and the community.
This article was reprinted from Volume 20, Issue 49, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »