DFG to fund nine clinical trials

September 13, 2005

The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has announced funding for nine clinical trials in a joint programme established in 2003 by the DFG and the German Federal Ministry of Education and Research (BMBF). This decision was reached by the DFG's Joint Committee at its meeting on 2 September 2005. The programme's objective is the long-term sustainable improvement of patient-oriented clinical research in Germany. This will foster the expertise of German university hospitals in terms of planning and carrying out clinical trials, helping to ensure its establishment on a broad basis.

Whereas the DFG will primarily fund diagnostic and non-pharmacological therapeutic procedures, the BMBF, which is funding eight additional clinical trials, will focus more on pharmacological therapeutic procedures. The DFG and the BMBF will each initially provide annual programme funding of €5 million until 2008.

The nine clinical trials to be funded by the DFG are as follows:

The clinical trial „Spiral CT Scanning for the Early Detection of Lung Cancer; Randomized Controlled Screening Trial of Multidetector Spiral CT Scanning in Germany" at the German Cancer Research Center in Heidelberg is part of an international study being carried out in Europe. Its objective is to improve the assessment of the benefits of annual screening by means of multidetector spiral CT, or MSCT, for patients with an increased risk of lung cancer. In Germany over 42,000 people are diagnosed with lung cancer each year, primarily smokers.
(Total funding: €651,911. Coordinator: Prof. Nikolaus Becker, German Cancer Research Center, Heidelberg)

Patients with cirrhosis of the liver tend to suffer from vasodilation, such as varicose veins in the oesophagus and the stomach. The most frequent cause of death is blood vessel haemorrhaging. However, conventional measures for controlling this risk of variceal bleeding also represent numerous risks. The clinical trial "Covered Transjugular Intrahepatic Portosystemic Stent Shunt versus Optimized Medical Treatment for the Secondary Prevention of Variceal Bleeding in Cirrhosis" will focus on whether a combination of new and conventional methods is able to significantly lower the risk of bleeding.
(Total funding: €598,550. Coordinator: Prof. Tilmann Sauerbruch, University of Bonn)

Patients with mental illnesses who are not treated after they are discharged from the hospital are often readmitted, which represents a significant expense. In the clinical trial "Effectiveness and Cost-effectiveness of Needs-oriented Discharge Planning and Monitoring for High Utilisers of Psychiatric Services", psychotherapists and psychiatrists from Ulm, Günzberg, Stralsund, Düsseldorf, Regensburg and Ravensburg will attempt to discover whether individually tailored pre-treatment and after-treatment consultation therapy would help to reduce costs.
(Total funding: €518,390. Coordinator: Prof. Thomas Becker, University of Ulm / Psychiatric Ward II at the Günzburg District Hospital)

The number of patients with psychosomatic physical disorders is high. Inability to work is frequently the outcome, an enormous strain, not only on the health care system. The clinical trial "Psychosomatic Intervention for Patients with Multisomatoform Disorder in Different Somatic Specialities (PISO)" will attempt to find out to what extent psychodynamic therapies can reduce these physical symptoms. Psychotherapists from Munich, Heidelberg, Düsseldorf, Regensburg and Münster are working together on the planning and evaluation.
(Total funding: €502,250. Coordinator: Peter Henningsen, privatdocent, Munich University of Technology)

Paediatricians at the Charité University Hospital in Berlin are trying to find out how far the death rate from viral infections, particularly among leukemia patients after a bone marrow or stem cell transplant, can be reduced by the preventative use of cellular immunotherapy. Their clinical trial "Adoptive Immunotherapy for Adenovirus Associated Complications Post Transplantation" focuses on affected children and young people between the age of 2 and 18.
(Total funding: €957,824. Coordinator: Dr. Sebastian Voigt, Charité - University Hospital, Berlin)

In the clinical trial "Bone Marrow Transfer to Enhance ST-elevation Infarct Regeneration-2 (BOOST-2)" a team from Hannover and Hildesheim, together with cardiologists from Göttingen, Berlin and Heidelberg, are researching whether or not an infusion of bone marrow cells into the coronary vessels can improve heart function after a heart attack. Whether the infusion of bone marrow cells actually does result in an improvement is the topic of heated debate worldwide. This trial will contribute significantly to answering this question.
(Total funding: €987,063. Coordinator: Prof. Helmut Drexler, Hannover Medical University)

Scientific studies have proven the effectiveness of antidepressants. However, it has not yet been shown that additional cognitive-behavioural therapy, or CBT, is successful in the long term. Psychologists and psychotherapists from Jena, Frankfurt/Main, Mainz, Erlangen and Tübingen are attempting to close this gap with the clinical trial "Combined Cognitive-behavioural and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression".
(Total funding: €709,600. Coordinator: Prof. Ulrich Stangier, University of Jena)

Patients with schizophrenia often not only suffer from the so-called "positive" symptoms typical of this disease, such as delusions and hallucinations. They are also impaired by "negative" symptoms (lack of initiative, emotional vacancy and depression). The clinical trial „Cognitive-behavioural Treatment of Negative Symptoms in Patients with Schizophrenic Disorders" being carried out by the University of Tübingen is intended to clarify whether cognitive-behavioural therapy is effective in treating these negative symptoms. This therapy has no side effects and may be a big step forward, particularly since negative symptoms frequently remain even after the positive symptoms have healed.
(Total funding: €743,317. Coordinator: Stefan Klingberg, privatdocent at the University of Tübingen)

Cooling is the preferred method of organ preservation at most transplant centres in Europe. Now that there are indications of a drop in organ damage due to the use of so-called machine perfusion, or MP, in which liquid is pumped through the blood vessels of organs to be transplanted, interest in this alternative has recently increased. The clinical trial "Machine Perfusion Preservation versus Simple Cold Storage of Cadaveric Kidneys for Transplantation" is comparing the advantages and disadvantages of both methods and attempting to evaluate the effectiveness of MP on a more solid basis.
(Total funding: €120,500. Coordinator: Dr. Jürgen Treckmann, University of Duisburg-Essen)

The decision to establish the Clinical Trials programme was made in October 2003, and the first call for proposals was announced in November 2003. A total of 335 draft proposals were submitted. The interdisciplinary, international review panel was selected jointly by the DFG and BMBF. Each proposal was voted on by the ethics commission.
For further information contact:

Dr. Annette Schmidtmann, , tel.: +49 (0)228/885-2243, email: Annette.Schmidtmann@dfg.de.

Deutsche Forschungsgemeinschaft

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