Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Conducting Clinical Trials in Orthopedic Indications in Germany

Karsten Gavenis (Abschlußjahr: 2013)

Summary

Language: English

This master thesis investigates the importance of orthopedic surgery for health care in Germany. Additionally, the regulatory framework for clinical trials in Germany is summarized, with special focus on orthopedic clinical trials.

Health care can be considered as one key industry in Germany. In 2009, 278.3 billion euro was spent on health care in Germany. Despite of economic and political efforts, it is expected to continually rise in the future. Orthopedic indications as defined by ICD-10-GM part XIII (Musculoskeletal System) are among the four most important areas, representing about 11% of direct health care expenses.

In Germany, orthopedic clinical trials with medical devices are regulated by the MPG; further details are given in the MPKPV. Approval of a competent authority and a positive statement of an independent ethics committee are required, although a formal approval may be omitted on request for low-risk medical devices.

The impact of clinical trials with orthopedic medical devices has been assessed by investigating the number of reported SAEs in Germany. Between 2000 and 2011, the number of SAEs related to orthopedic medical devices reached from 483 to 1283, reflecting a general increase of clinical trial numbers in these years. This is corresponding to 18.1% to 27.3% of the total number of SAEs reported in this period. The vast majority of cases are related to non-invasive implants, illustrating the importance of this segment of the orthopedic device market.

Clinical trials with medicinal products are regulated by the AMG; further details regarding the CTA are provided by the corresponding GCP-V. Both approval of a competent authority and positive statement of an independent ethics committee are required.

Between 2005 and 2011, the number of CTAs of ATC code “M”, the musculo-skeletal system, reached from 21 to 41, representing 1.7% to 3.0% of the total CTA number. About two third of the clinical trials of ATC code “M” are represented by M01A (Anti-inflammatory and anti-rheumatic products, non-steroids) and M03A (Muscle relaxants, peripherally acting agents). The importance of M01A in particular is reflecting trends in health care due to an aging population displaying an increased number of joint-related illnesses.

Non-AMG, non-MPG clinical studies are of special importance in orthopedic surgery. These studies often consist of a comparison of different surgical techniques or medical devices implanted by surgical techniques. Regulatory requirements include compliance with the code of medical ethics laid down by the German Medical Association and the Declaration of Helsinki, where general ethical principles for bio-medical research on humans are defined. These include consultation of an independent ethics committee, but no approval by a competent authority.

Important trends in orthopedic research include the development of improved minimally-invasive surgical methods and enhanced medical imaging techniques. Furthermore, cartilage tissue engineering is increasingly investigated to preserve the functionality of knee and hip joints, which is likely to fail at some time in aged people. Cold atmospheric pressure plasma may serve to improve the biocompatibility of orthopedic implants and to facilitate wound healing.