klausrose Consulting

klausrose Consulting was established in 2011 as a company to advise pharmaceutical companies on pediatric clinical studies and other measures demanded by the regulatory authorities in the approval process for new drugs. As the company’s name shows, “pediatric drug development” was perceived as something positive in 2011. During the following years, klausrose Consulting has advised countless companies, mainly on pediatric investigation plans (PIPs) for the European Medicines Agency (EMA), and on comparable requirements by the US Food and Drug Administration (FDA). Clinicians also sought advice on drug development for children and potential research projects. In the context of these consultations, a change of position has taken place in recent years in the CEO’s opinion. Most of the studies on children requested by the EMA showed errors and shortcomings that already in 2011 were silently smiled at or complained about by customers. Critical articles in international peer-reviewed scientific journals followed. Through these publications and discussions at international conferences it gradually became clear that the demands for approval studies in “children” are based on a fundamental blur.

The authorities define “children” as anyone younger than 18 years. But this definition is administrative, not physiological. Young persons mature bodily much earlier than they reach the 18th birthday. And children before puberty are no longer as immature and vulnerable as newborns and babies. The 18th birthday is an administrative age limit and does not correspond to an overnight physical change. Why do researchers and the authorities demand studies in “children”? There is a fundamental conflict of interest now documented in many articles and in a first medical textbook. These studies allow “pediatric” careers in academic research, in regulatory authorities, in clinical research organizations (CROs ), and also in pharmaceutical companies. They do not advance children’s health. On the contrary. At best they are useless, at worst they harm. A new challenge of the global civilization in the 21st century at the interface of medicine and law, as well as at the interface of drug development, drug approval, and science.

With this discovery, the business of klausrose Consulting has further evolved and expanded. In addition to advising pharmaceutical companies, scientific publications discuss useless and often even harmful studies in “children”. Furthermore, the company now advises persons and institutions that, privately or professionally, want to advance child health and want to protect minors from exploitation. These persons and institutions include parents of children with rare and/or complicated diseases who have to decide about the participation in a clinical study; journalists, lawyers, members of institutional review boards/ ethics committees, politicians, patient & parent advocacy groups, & more.

With the publication of the first critical medical textbook in 2020,1,2 and the upcoming release of the next book,3 this transition is expected to accelerate.  When the travel restrictions due to the corona pandemic will be lifted, international conferences will take place again. The first online training in pediatric drug development will take place on 9./10. September 2021.4 The company is open to questions, proposals, and suggestions.

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