How should one prepare for the IIT?

Basics, planning and implementation of non-commercial clinical studies

Summary

Proof of the effectiveness of drugs in randomized, controlled clinical trials forms the basis of evidence-based medicine and thus many therapeutic decisions. Clinical trials according to the Medicines Act can be carried out with commercial interest by pharmaceutical companies as "company-sponsored trials" (CST) or by non-commercial institutions, mostly university hospitals, as "investigator-initiated trials" (IIT). Particularly for questions for which there is no commercial incentive, there would be no scientific knowledge gain without IITs. This means that non-commercial clinical trials are indispensable for improving medical care. In order to guarantee the protection of the test persons and a high quality of the collected data, clinical tests are subject to many legal regulations and internationally recognized quality standards. The implementation therefore requires in-depth knowledge, qualified personnel, a suitable infrastructure and considerable financial resources. In contrast to a CST, in the case of an IIT this must be done independently by the university clinic. Since knowledge about the implementation of clinical examinations is only imparted selectively in the course of studies and in specialist medical training, this article is intended to show physicians without prior experience with clinical examinations to introduce the topic how a clinical examination is defined and how responsibilities are defined are distributed and how a clinical trial works.

Abstract

The proof of a drug’s efficacy in randomized controlled trials is fundamental to therapeutic concepts determined by evidence-based medicine. Clinical trials according to the German Medicinal Products Act are performed by the pharmaceutical industry as company-sponsored trials (CST) driven by commercial interests or by non-commercial facilities as investigator-initiated trials (IIT), typically implemented by University Hospitals. In areas with no commercial interest, IITs are the driving force that generate scientific progress leading to treatment optimization. Therefore, non-commercial or investigator-initiated clinical trials are indispensable for improving medical care. To ensure the safety of trial participants and the quality of the data obtained, clinical trials are controlled by many legal regulations and internationally accepted quality standards. Therefore implementation of a clinical trial requires profound knowledge, qualified personnel, appropriate infrastructure, and substantial financial resources. In IITs unlike CSTs this has to be accomplished by the University without the assistance of the pharmaceutical industry. Since teaching of skills needed to perform clinical trials is still largely neglected in medical school and during residency this review addresses the (in clinical trials) inexperienced physician and outlines the characterization of a clinical trial, the range and division of responsibilities and the performance of clinical trials according to the German Medicinal Products Act.

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Conflict of interest

The corresponding author declares that there is no conflict of interest.

Author information

Affiliations

  1. University Eye Clinic Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany

    Dr. R.P. Finger & F.G. Wood

  2. Institute for Clinical Chemistry and Clinical Pharmacology, Clinical Study Support Core, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany

    Dr. C. Coch, M. Coenen & G. Hartmann

  3. Medical Clinic and Polyclinic I, Bonn University Hospital, Bonn, Germany

    M. Mengel

Corresponding authors

Correspondence to Dr. R.P. Finger or Dr. C. Coch.

additional information

___ ___

The authors R.P. Finger and C. Coch contributed equally to the work.

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Finger, R., Coch, C., Coenen, M. et al. Basics, planning and implementation of non-commercial clinical studies. Ophthalmologist108, 25-32 (2011). https://doi.org/10.1007/s00347-010-2310-9

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keywords

  • clinical research
  • "Investigator-initiated trial"
  • "Company-sponsored trial"
  • Medicines Act
  • Proof of effectiveness of drugs

Keywords

  • Clinical research
  • Investigator-initiated trial
  • Company-sponsored trial
  • German Medicinal Products Act
  • Proof of drug efficacy