Declaration and Handling of Conflicts of Interest in Guidelines: A Study of S1 Guidelines From German Specialist Societies From 2010-2013.

Background: Authors' conflicts of interest may affect the content of medical guidelines. In April 2010, the Association of Scientific Medical Societies in Germany (AWMF) issued recommendations on how such conflicts of interest should be dealt with. Most AWMF guidelines are so-called S1 guidelines developed by informal consensus in a group of experts.

Does the pharmaceutical industry influence guidelines?: two examples from Germany.

Background: The recommendations in clinical guidelines are based on clinical trial findings and expert opinion. The influence of drug companies on these two factors is illustrated with two examples.

Methods: A judicially ordered expert review revealed that the market authorization holder (MAH) of gabapentin manipulated study data.

[Clinical trials in oncology: deficits and proposals for solution].

Various investigations have identified deficits in clinical studies conducted for the market authorisation of haematological and oncological drugs. Based on data from European Public Assessment Reports (EPAR) of the European Medicines Agency (EMA), an analysis of the quality of these studies, which serve as the basis of marketing authorisation of currently approved drugs, is showing improvement. For example, endpoints recommended by the EMA are frequently used.

[The relation between publication bias and clinical trials funding].

Publication bias describes the distortion of data in scientific journals resulting from the fact that studies with significant and positive results are more likely to be published than studies with negative or insignificant results. In studies funded by pharmaceutical companies publication bias has a considerable impact. It has been shown that more than half of the studies that are conducted as part of the drug approval process will remain unpublished.

The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication.

Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This overview of current, systematic studies on this topic is intended to identify and characterize the particular aspects of the performance of a drug trial that can be affected by financial support from a pharmaceutical company.

The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials.

Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This paper provides an overview of the findings of current, systematic studies on this topic.