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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :Investigator-Driven Clinical Trials: An ESF Forward Look.. 2010-06-03 09:27:58 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear friends,

The European Medical Research Councils (EMRC) mandated the undertaking of a foresight study on ‘Investigator- Driven Clinical Trials’ (IDCT). This project marks the most comprehensive examination and analysis of the issue in Europe and proposes particular steps towards better clinical research in Europe. Investigator-driven clinical trials - trials instigated by academic researchers aimed at acquiring scientific knowledge and evidence to improve patient care – deal with potential diagnostic and therapeutic innovations that do not attract or could be even against commercial interest.

In order to tackle these problems faced by researchers conducting IDCT a thorough analysis of the issues was carried out through a series of five workshops covering different themes and attended by active and acknowledged experts in the field. A total of 26 recommendations emerged addressing needs and solutions, the top five of which are the following:

  • To improve the education, training and career structure and opportunities for scientists involved in patient-oriented clinical research.
  • To increase levels of funding for IDCT. 
  • To adopt a ‘risk-based’ approach to the regulation of IDCT.
  • To streamline procedures for obtaining authorization for IDCT.
  • To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results so that the trials are ‘correctly powered’.

Europe needs to listen and implement the recommendations, which are urgently required given that clinical research in Europe is under severe pressure.’ Download the IDCT report here.

Kind regards,

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