BERKELEY, CA (UroToday.com) -
The Endourological Society was set up to facilitate dialogue between endourologists worldwide and is today one of the major urological societies. The Clinical Research Office of the Endourological Society (CROES) was set up in 2008 and is responsible for organizing, structuring and facilitating a global network for endourological research. Over the past 30 years, an increasing number of innovative surgical techniques and devices have been introduced, leading to the evolution of endourology and its related fields into the main body of urological surgery. Parallel to these developments, a certain flow of urological research has similarly developed. Randomized controlled trials (RCT) have long been considered the reference standard for the evaluation and establishment of diagnostic procedures and therapeutics. However, the rate of accrual to RCT often remains low and frequently they do not reflect real life practice.  In contrast, high quality clinical databases offer an alternative approach, with the potential to bring research closer to daily practice while providing for wide ownership and high generalizability through the participation of many clinicians. Other advantages include relatively low costs per study, the ability to generate large samples rapidly, the opportunity to collect a significant sample of a rare condition or non-standard intervention and the provision of accurate information for clinical practice, audit and administration.
The CROES studies
The first study undertaken by CROES focused on percutaneous nephrolithotomy (PCNL) for renal stone removal and was conducted during November 2007 and December 2009. Close to 100 sites from Asia, Europe and the Americas participated in the PCNL Global Study and in the course of 1 year, almost 6000 patients were treated. Data from this study are currently being mined to answer multiple questions with regard to PCNL. These questions cover the entire spectrum of clinical research from learning curves to efficacy of different treatment modalities. Since the initiation of CROES, four other projects have been defined and are now ongoing. These studies include: an observational study on KTP laser for treating benign prostatic hyperplasia, the treatment of renal masses, ureteroscopy for urinary stones and narrow band imaging in the diagnosis and treatment of bladder cancer.
Infrastructure to support and conduct studies
All research undertaken by CROES-approved investigators is subject to the rules set forward by (inter)national health care authorities. These rules mandate institutional review board (IRB) approval of any research with human subjects. Another prerequisite for the CROES studies is the development of high quality databases, the benefits of which long been recognized. Such a database must include individual data on all consecutive cases, use standard definitions of conditions and outcomes, ensure data are complete and accurate, and include data on all known patient characteristics that might affect outcome. CROES fully endorses these recommendations and aims to conduct all studies according to the highest standards of ethics and quality. To facilitate entry of patient data at each CROES site, a paperless, centralized web-based data collection system has been established.
Creation of a global network
In the next decade, there will be many challenges and threats to healthcare. What can international organizations do to successfully meet these challenges and overcome the potential threats? Clearly, priorities and choices must be made. By drawing on the expertise, experience and catalytic potential of researchers, the urological community can fully capitalize on the diverse intellectual resources to make lasting contributions to global health. We believe that CROES can provide a platform for such an international endourological network thereby enabling a critical analysis of current patterns of practice and providing data upon which decisions can be made for the fiscally responsible, future delivery of effective healthcare.
We underscore the conclusion made by Glickman et al. that long-term solutions to problems arising from the globalization of clinical research will require input from stakeholders in academia, industry, and regulatory agencies around the world. Consequently, we must ensure the ethical and scientific integrity of clinical research globally, promote harmonization of international research, and provide information about the benefits and risks of new drugs and devices among populations and environments worldwide.
The CROES council members include Drs. Dean Assimos, Stavros Gravas, Adrian Joyce, Tadashi Matsuda, Margaret Pearle, and Ying-Hao Sun.
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- De la Rosette J, Assimos DG, Desai M, et al. The Clinical Research Office of the Endourological Society (CROES) percutaneous nephrolithotomy (PCNL) global study: indications, complications and outcomes in 5803 patients. J Endourol 2011;25:11–7.
- Glickman SW, McHutchison JG, Peterson ED et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009;360(8):816–823.
Jean J.M.C.H. de la Rosette, MD on behalf of the CROES Councilas part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.