Investigators selection & application via the European Urologists Clinical Trialist Database
Join CuraTrial and the Clinical Research Office as we investigate therapeutic agents in urology and women's health. Our team of professionals play a critical role in the advancement of medical science. You will have the opportunity to receive on a regular basis interesting protocols to carry out, financial rewards, as well as to publish unique research experiences.
Background Recent surveys from Centerwatch, an organisation which provides information to the clinical trial industry, indicate that more than 50% of the delays in phase II-III clinical trials are caused by poor patient recruitment. Besides this 80% of all clinical trials experience enrolment delays. The same was shown ten years ago. It is an indication that organisations currently involved in conducting clinical phase II-III trials have not succeeded in improving patient recruitment. Since investigators are primarily responsible for patient recruitment, it is also they who are able to substantially enhance patient recruitment. The key to successfully promote a quicker introduction and development of new treatments is to improve the efficiency of the clinical trial process at the centre (site). This is where the clinical research activities take place.
Therefore, in both industrial (pharmaceutical and medical device) and nonindustrial research, there is a clearly identified need for committed and high output, high quality investigators to advice on the design of clinical trials and to participate in clinical trials. And obviously an improved patient recruitment is of key importance.
This is clearly one of the challenges for the EAU Research Office!
Clinical Trialists Database, why ?
We, the EAU Research Office, need a better overview of the potential of the European urologists. We aim to improve the current standard as well as to improve the overall standard of clinical research in European urology across a wide range of subspecialty areas. This is why the Research Office decided to develop a clinical trialists database. In this database characteristics are collected from European urological centres and institutions interested in participating in clinical trials managed by the EAU Research Office.
The clinical trialists database may serve as a tool, to be consulted by you and us, in case the Research Office receives initial feasibility questions for clinical trials. Also - in case your centre is to participate in a trial in the future - we consider tracking several key performance indicators (time to ethical committee approval, percentage of recruited vs. committed patients, number of queries etc).
We also aim to identify and select potential investigators who will enable us to speed up the clinical trialing process, recruit patients faster, and more efficiently and effectively deliver the highest quality patient data. This way the EAU will become a reliable partner for sponsors (e.g. pharmaceutical companies, medical equipment manufacturers and non-industrial organisations) in conducting multicentre phase II-III clinical trials.
We hope that this database will eventually help us reach one of our major goals, which is to efficiently organise the clinical trialing process, both centrally and locally. The result will hopefully be that new treatments, drugs and technology will become available to our patients sooner.
Where does the EAU-Research Office stand today ?
Since 2004 CuraTrial acts as the contract research organisation for the EAU and is involved in the practical realisation of the key-targets of the Research Office. Curatrial is functionally integrated within the organisation and infrastructure of the central office of the European Association of Urology in Arnhem, and is also owned by the EAU. CuraTrial's staff consists of clinical research experts with a scientific and methodological background. CuraTrial's employees write protocols for clinical trials, implement trials, monitor and manage data. They in general manage the entire project including the appropriate data-entry, reporting and data analyses. CuraTrial works according to standard operating procedures as set by the latest ICH-GCP and EU guidelines.
Through CuraTrial the EAU Research Office is currently conducting a large European multi-centre trial: the Zometa EUropean Study, the ZEUS study. The Research Office also facilitates the activation of a European registry on minimally invasive treatment for BPH (Trans-Urethral Needle Ablation -TUNA therapy). Furthermore, we have 2 additional registries starting this year and we are now in the stage of investigating the feasibility of another large multi-centre urological project on renal cell cancer.
How can you become an EAU research centre ?
In case you are interested in participating in this project we kindly request that you complete the questionnaire, clearly indicating your fields of interest and define your number of diagnoses for each separate urological pathology. The completed questionnaire can be sent to:
By mail: EAU Research Office, PO Box 30016, 6803 AA ARNHEM The Netherlands
By fax: +31(0)263890679 Preferably directly via the web.
The questionnaire is available on a website launched at this Annual EAU Congress in Paris, 2006. We are looking forward to receive your contribution.
Sincerely yours,
Wim P.J. Witjes, MD, PhD
Clinical Research Director, CuraTrial
Per-Uno Malmström, MD
EAU, Research Office
We provide protocol specific patient recruitement strategies
