(Letzte Aktualisierung: 18.07.18)
Quality management
Quality management for medical research
Under the TMF umbrella organization, the research community is able to respond quickly to the new demands placed on science-driven trials.
In order to achieve reliable results from medical research, it is vital that the most stringent quality standards are in place when planning, carrying out and evaluating clinical trials. This applies to both science-driven trials as well as trials initiated by the pharmaceutical industry. Accordingly, the amendment to the German Pharmaceutical Products Act ('AMG') in 2004 (12th AMG amendment) on the basis of European Directive 2001/20/EC ensured that the quality requirements made of science-driven trials are practically the same as those for industry-sponsored trials. So-called treatment optimization trials in which already approved medication is used are particularly affected by these changes.
For the most part, the TMF member networks carry out non-commercial, science-driven trials and, as such, following the summer of 2004 there was a great need for information and support. Under the TMF umbrella organization, the research community was able to rapidly respond to the new requirements: training for communicators was developed and performed, checklists were made available and a series of Standard Operating Procedures was created.
Furthermore, concepts and tools for example for the electronic reporting of side effects and adverse events in clinical trials were evaluated and developed. On the one hand science-driven trials differ from industry-sponsored trials in terms of the budget available and often, on the other hand, as regards the potential risk to patients. A study initiated in the TMF therefore developed adaptive monitoring strategies for such trials that are customized to the trial design and, at the same time, comply with the goals of Good Clinical Practice (GCP). In 2008 a comprehensive evaluation of these monitoring strategies compared to conventional and often more complex methods was launched.