In order to develop modern safe medicines and therapies for patients, intensive clinical tests are required in addition to innovative preclinical research. Studies in early clinical phases of drug development require dedicated facilities in highly specialized hospitals. The first steps in testing new substances focus on safety, tolerability and pharmacokinetics in single ascending doses and multi-dose regimens. In general, those studies are carried out in healthy volunteers (phase I trials) or - in oncology - in patients with the target disease (phase IIa trials). Dose-finding and early effectiveness may also be part of phase I-II trials. Phase I or early phase II trials require intensive monitoring and care.
The IKP Clinical Trial Unit at the Robert-Bosch-Hospital (RBK) under the responsibility of the IKP has three inpatient beds with availability of continuous monitoring with immediate access to the intensive care unit and imaging modalities in case of severe adverse drug reactions. Specially trained medical doctors with board certification in clinical pharmacology and study nurses with experience in the conduct of early clinical trials take care of the study participants on a daily basis. In addition, the IKP trial unit is supported by the activities of the Early Clinical Trial Unit (ECTU) of the Dept. of Clinical Pharmacology in Tübingen, which is located at the University Hospital Tübingen and joins resources with the phase I/II trial unit of the Department of Internal Medicine VIII (Medical Oncology and Pneumology, Prof Lars Zender). Independent from phase I/II trials the IKP initiates and/or participates to in-house as well as external phase III trials and biomarker studies.
IKP has a long-standing experience in the preparation of principle investigator initiated (PII) study protocols and concise and readable informed consent forms. Moreover, the IKP offers advice for clinicians at the RBK to accelerate and initiate PII drug trials. In the past members of the IKP conducted several PII and industrial-sponsored pharmacological trials, particularly in the early phase. In addition, trials to elucidate novel biomarker and/or diagnostic tests have been conducted.
As member of the ethics committee at the State Medical Association Baden-Württemberg, Stuttgart, Germany (M Schwab since 2004) and the Ethical Committee of the University Hospital Tübingen, Germany (M Schwab since 2017) the IKP is also involved in the evaluation and approval of phase I-IV studies from a clinical pharmacologist’s perspective. Here, unique challenges of phase I/IIa studies include adequate dose-escalation regimens and the risk-benefit ratio for individuals who do not have an individual treatment benefit. Moreover, close co-operations with competent authorities, other regulatory bodies as well as partners in the healthcare system are well established.