Phase I- und II-Studien und die Vorteile lokaler CRO-Dienstleistungen

Managing clinical trials in early phases comes with unique demands and challenges. Well-executed Phase I and II trials are key to achieving research milestones and positioning new treatments for market success. Sponsors must be able to rely on a strong partner to conduct Phase I and II trials — and in most cases, a local, highly specialized CRO offers the best chance of success. Here, we discuss the top reasons to consider a smaller CRO when conducting early clinical research, as well as our team’s insights on managing clinical trials in Eastern Europe.

The Risks of Choosing a Global CRO for Phase I and II Trials

In a survey distributed to over 450 industry professionals in the United States and Europe, OCT Clinical found that 81% of respondents deemed CRO-Sponsor relationships as “Very Important” or “Important.” Furthermore, more than 60% of respondents expressed that they were not fully satisfied with global CRO services, and failed to meet their original enrollment goals.

CRO services are not one-size-fits-all. Though most CROs have the same core capabilities, their expertise does not always match the needs of the trial. Large, global CROs have a wider reach, and can appear to have more resources behind them. But they typically do not bring the level of regional knowledge necessary to give studies needed momentum at their earliest stages.

Working with a global CRO often comes at a higher cost, but that does not equate to higher quality CRO services. In fact, most large CROs will not provide highly-experienced teams for smaller-budget  projects. The result is that smaller clients will not get nearly as much attention or insight as higher-paying companies.

To ensure the intricacies of Phase I and II trials are accounted for, aim to answer the following questions when selecting a CRO:

How Local CROs Differ When Offshoring Clinical Trials

The barriers that once prevented organizations from forming successful overseas partnerships have been largely eliminated. The progression of technology, accelerated adoption of virtual trial operations, and the increasing globalization of the pharmaceutical industry have made Sponsor-CRO relationships less and less reliant on physical and cultural proximity. Circumstances of the COVID-19 pandemic have further normalized the digitalization of clinical research.

All things considered, Sponsors have never enjoyed more flexibility in selecting CROs best equipped to handle therapeutic factors and other special considerations for their studies. Choosing to work with a small or mid-size regional CRO usually means Sponsors can count on more frequent and personal communication, on-the-ground support, and better project management in clinical trials they are running.

For Phase I and II trials, strategies for patient recruitment directly impact timelines and overall project success. Sponsors should look for a partner with access to large populations of qualified patients, and the best CRO services for patient engagement. Local CROs can bring depth of expertise in specialty areas. They often have better access to treatment-naïve populations, and apply their knowledge of the research and regulatory environments in the areas where their teams live and work. 

A Closer Look at Outsourcing Clinical Trials to Russia

According to the FDA, Russia comes second after the US in terms of the number of subjects recruited for studies. With a population of 142 million, the patient pool is vast enough to support clinical trials in Russia in almost any indication. Russia has been demonstrating record-breaking recruitment rates with a significant number of treatment naïve study subjects. This is partly caused by the specifics of the national healthcare insurance system, where patients often do not have access to timely and efficient treatment. 

A centralized healthcare system with large, specialized medical centers is very conducive to conducting clinical trials in Russia, allowing for rapid patient recruitment. As shown by figures from studies launched in 2020, many Russian sites are global leaders in relevant therapeutic areas, including Oncology (137 studies), Infectious Diseases (99 studies), Neurology (72 studies) and Cardiovascular  (61 studies). 

OCT Clinical has been managing clinical trials in Eastern Europe since 2005. Our team has helped conduct a total of 97 trials in Phases I and II, and has successfully recruited over 50,000 patients. With access to a network of over 1600 leading research sites, our experts help Sponsors conduct efficient, high-quality research by connecting them with large populations of qualified participants in Eastern Europe. To find out how we can help your trial succeed, contact us today.

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