Abstract
Simple SummaryThis opinion paper describes the regulatory hurdles for a clinical oncologist and physician scientist to activate an Investigator-Initiated Trial (IIT) before and after 2004 with German regulation as an example. Changes in legal framework with impacts on time and costs to activate a clinical trial are described. Evidence needed to reach the objective of higher patient safety and trial quality by European Union (EU) Clinical Trial Directive (CTD) 2001/20 is discussed.Shortly after the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously. They included the European Union (EU) Clinical Trial Directive (CTD) 2001/20 followed by major changes in national drug laws, the change in the legal status of German University Hospitals (1998), and a new disease-related groups (DRG)-based reimbursement system for hospitals in Germany (2000). Together, these changes created enormous bureaucratic and financial inhibition of activation and conduct of academic investigator-initiated clinical trials (IIT). Examples for activating clinical trials in oncology before and after 2004 are outlined and discussed, focussing on extended time frames, the establishment of centralized responsibility structures and the exploding financial consequences. In addition, the evolution of trial numbers and the distribution of trial initiators between “commercial” and “academic” over time are discussed together with the occurrence of clinical registries. At the same time, progress in molecular biology led to a plethora of new targets for effective pharmacological therapy of life-threatening diseases such as cancer, and the overall number of clinical trials has not decreased. Yet, judging the regulatory and administrative hurdles between scientific study design and first-patient on trial before and after 2004 and weighing these against the lack of evidence that this regulation has achieved its goal to enhance patient safety and trial quality, the necessity to completely overhaul this CTD becomes obvious. A main goal of such an initiative should be to minimize bureaucracy. For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician–scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for IITs.
Highlights
After the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously
For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician–scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for initiated clinical trials (IIT)
Since the 1990s, groups have worked according to Standard Operating Procedures (SOP) edited and all study groups of the German Cancer Society (DKG) and its subgroups have worked acagreed upon by investigators from all study sites [6]
Summary
In early 1981, I wrote a study protocol for a monocentre phase I trial studying an “investigational medicinal product” (IMP) of a novel class of antitumor compounds with a new mode of action. The calculated costs for such a trial were negligible as treatment was reimbursed by health insurances as a standard of care and patient surveillance plus documentation were performed by the investigators as standard tasks within clinical patient care Publication of this trial with results on 26 patients appeared within 1 year in an international peer-reviewed journal [4]. Since the 1990s, groups have worked according to Standard Operating Procedures (SOP) edited and all study groups of the German Cancer Society (DKG) and its subgroups have worked acagreed upon by investigators from all study sites [6] Such a trial structure in oncology cording to Standard Operating Procedures (SOP) edited and agreed upon by investigators facilitated continuous therapeutic improvement by scientific consensus on treatment from all study sites [6].
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