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SP0081 Investigator-Initiated Clinical Trials - How to BE Successful
  1. C.F. Allaart
  1. Rheumatology, Leiden University Medical Center, Leiden, Netherlands


What is “to be successful” regarding investigator-initiated clinical trials? To get started with the right hypothesis, forging collaborations with co-investigators, producing a trial protocol, finding financial resources to put it into action, steering the protocol through medical ethics committees, hiring and training the best trial personnel, including sufficient numbers of patients in the estimated available time, motivating patients to remain in the trial and doctors to follow the protocol (and making sure that everyone does), ensuring that data collection is complete and usable, analysing the results and finding methods to overcome unforeseen complications, writing a paper and publishing the results in a respected journal ... each activity completed may be considered “being successful”, and any mishap along the way may prevent the whole enterprise from becoming successful in the end. Some experiences and potential tips from the BeSt and IMPROVED studies will be shared.

To make the trial successful beyond being published, abstract presentation at national and international conferences is an effective way to summarize the background and outcomes of the trial. Also, presenting the data as well as him- or herself, the investigator can now begin to feel a bit successful too. Continued success lies in being able to expand on the initial papers and presentations with new data, combined with repetition of the results, either by the original presenters or by others. It helps to have a trial sponsor who is interested in getting the investigators into contact with colleagues in the field. Implementation in daily practice of the trial results could mean that it, and the investigators if this was their intention, were successful. However, implementation often requires a whole new strategy and financial support structure. Collaboration and data sharing is the next step, potentially leading to more exposure for both the clinical trial and the investigators. This in turn may be of benefit when the next trial is considered, which may also become successful if the above milestones are once again achieved.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.6336

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