Directions

In the 1st stage of the EU project PROFID, the results of retrospective AI analyses of clinical databases with >200,000 patients were presented internationally. As a result of this preliminary work, the design of the PROFID study has now been finally approved by the relevant committees. The set-up phase of this large-scale project has now started at CRI.

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A novel device for simplified home ventilation in COPD patients is being investigated in France and Germany as part of an MDR approval study.

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This prospective study is a direct continuation of the successful TIGER study. The objective of the TIGER PRO-Active study is to evaluate cognitive function and daily sleep quality in patients with newly diagnosed GBM and TTFields therapy in routine clinical practice. Automatic tracking of sleep quality will be performed via an app installed on the patient's smartphone. Approximately 500 patients in 70 study centers in Germany will be followed up over several years.

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Telemedical monitoring of patients using medical devices is becoming increasingly important to ensure the most optimized, individualized treatments possible. In this study, approximately 250 patients in Germany, Spain, UK and France using home ventilation with telemedical monitoring in routine clinical practice will be followed up for 2-3 years and, among other things, the impact of continuous monitoring on the rate of hospitaisations during the course will be investigated.

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The highly anticipated results of the EAST trial were simultaneously presented in a hotline session at the ESC Congress and published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa2019422). These results will change medical guidelines for the treatment of atrial fibrillation worldwide.

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A total of 2,810 patients were enrolled in the trial at 135 study centers in 10 countries in Europe and followed up for more than 5 years. Results are expected this fall.

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In the past, the cardioverter defibrillator (ICD) was the clear choice after a heart attack in case of impaired pump function. But the situation has changed, in part because of advances in pharmacotherapy. However, in recent years, the treatment of these patients changed decisively with a whole series of new drug classes that greatly reduced not only mortality but especially the risk of sudden cardiac death, while at the same time the long-term complication rate of defibrillator therapy remained at a relevant level. Meanwhile, the risk-benefit ratio of primary prevention of sudden cardiac death by routine ICD implantation is expected to be different. The relevance for patients and health care systems is enormous: in the EU, it is estimated that approximately 45,000 primary prophylactic ICDs are implanted after myocardial infarction annually, at a cost of more than 500 million euros per year.

It is time to review the current therapeutic strategy by a randomized trial in more than 3,500 patients in > 200 study centers across Europe. Therefore, PROFID is funded by the EU Commission independently from the industry with a duration of more than 5 years.

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The study is investigating the effects of Adaptive Servo Ventilation (ASV) in routine clinical practice on daily life or activity of patients with sleep disorders in Germany, Switzerland, Spain, Denmark and France with analysis of effects on daytime sleepiness, quality of life and hospitalization. A total of up to 1,000 patients will be included in approximately 50 study centers.

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One method for treating chronic skin wounds without antibiotics relies on the use of cold atmospheric plasma, an ionized gas at room temperature. Cold plasma has a wide variety of properties, one of which is effective inactivation of bacteria without harming human tissue. It has been shown that even a short plasma treatment (a few minutes per session) can significantly reduce the bacterial count in chronic wounds. This is done without side effects and without pain. In this study, data on the treatment of chronic skin wounds with a new, approved device that generates cold atmospheric plasma will be obtained and analyzed.

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Therapy of patients with chronic heart failure with implanted three-chamber devices is called "cardiac resynchronization therapy" (CRT). CRT devices are available as pacemakers (CRT-P) or as much more complex and cost-intensive defibrillators (CRT-D). In the vast majority of patients with chronic heart failure receiving CRT therapy, there is currently considerable uncertainty about whether the defibrillator function of the device (-D) is needed and whether its benefits outweigh its risks. The question of whether a CRT-D is superior to a CRT-P in these patients has never been prospectively investigated in a randomized clinical trial. The aim of the study is very relevant for the daily treatment routine: In Germany, treatments with CRT-D systems are performed in the overwhelming majority of cases, about 90%.

The study is publicly funded by the G-BA and will be conducted in about 120 study centers in Germany for 3-4 years.

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Glioblastoma (GBM) is the most common malignant brain tumor in adults. The use of tumor treating fields (TTFields) in combination with chemotherapy was the first treatment modality since 2005 to demonstrate a significant prolongation of median overall survival and significantly improved survival rates over five years in a study. The current study is designed to provide data for use in routine clinical practice in 1,000 patients at 80 centers in Germany.

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Another big trial, the NOAH – AFNET 6 study, sponsored by the non-profit research network AFNET e.V. has started. By the end of June the first patient has been included. In total 3400 patients will be enrolled into this international phase IIIb study in about 230 sites in 15 European countries.

The main purpose of the NOAH - AFNET 6 study is to demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardiovascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with atrial high rate episodes (=AHRE) but without atrial fibrillation and at least two stroke risk factors.

CRI is the full service lead CRO for this project and will provide all necessary services ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes also all regulatory issues, handling of contracts, data management services as well as monitoring, safety and site reimbursement.

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The unexpected results, which caused quite a stir among experts, were presented at the ESC (European Society of Cardiology) Congress 2015 in London in the Hotline Session. At the same time, the first publication in the "New England Journal of Medicine" took place:

http://www.nejm.org/doi/full/10.1056/NEJMoa1506459

Even before publication, the sponsor had communicated preliminary safety results worldwide to the relevant authorities and all patients in an urgent safety alert:

https://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/mitteil2015/pm8-2015.html

Additional results from the SERVE-HF study are currently being prepared for publication.

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By mid-June 2,000 patients have been enrolled in the EAST – AFNET 4 trial. The investigator initiated clinical trial ‘Early treatment of atrial fibrillation for stoke prevention trial’ (EAST) is currently conducted in 11 European countries with more than 100 participating study sites and compares to different therapeutic strategies for the treatment of atrial fibrillation. The trial investigates whether the course of disease of patients with recently diagnosed atrial fibrillation can be influenced in a positive manner due to early rhythm control therapy in comparison to usual care therapy. Controlled clinical trials published to date could not provide evidence that patients benefit from an early rhythm control therapy whereby rhythm control measures were applied quite late.

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SERVE-HF study: follow up was completed successful in April 2015. Now the final assessment period is ongoing. Firs results of preliminary analyses are available. Please visit: http://www.resmed.com/servehffaqs/index.html

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International phase IV trial on the topic of catheter ablation of atrial fibrillation and anticoagulation with NOACs. About 60 study sites in Europe and the Unites States will include and follow up on about 630 Patients until mid-2017. Sponsor is the non-profit research network AFNET e.V.

CRI is the full service lead CRO for this project and will provide all necessary services in cooperation with an US based partner CRO, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

http://www.kompetenznetz-vorhofflimmern.de/en/axafa-trial-examines-noac-apixaban-during-af-catheter-ablation

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Slightly over a year after the end of recruitment for the SERVE-HF study the data collection for the “Major Substudy” (Substudy on the mechanistic plausibility of the clinical benefits of adaptive servo-ventilation) has come to a close. The required number of follow-ups with the accompanying imaging techniques has even been surpassed by far. The follow up of all patients in SERVE-HF will continue until mid-2015 and analysis of the data will have to wait until after this time point. First results are expected to be published in fall of 2015.

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Rare diseases can generally only be detected and observed in larger clinical registers. This also applies to the diagnosis of rare thrombotic microangiopathies. The goal of this epidemiological study is to find out the frequency with which bacterial infections or bleeding disorders are the cause and whether other clinical factors may be of aid for the differential diagnosis. We expect to document about 300 patients until April 2016.

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It is being studied under regular treatment conditions, whether the WCD may temporarily protect potentially vulnerable patients. This is, for example, necessary after acute myocardial infarction when the pumping function of the heart is severely limited and, consequently, life-threatening cardiac arrhythmias can occur. On the other hand, the spontaneous recovery of heart failure is possible.The register 700 patients will be documented and tracked until January 2017. 

CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

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In the beginning of November 2013 1,000 patients were randomised in the AFNET-EAST trial. The EAST study („Early treatment of atrial fibrillation for stroke prevention trial”) is ongoing in 11 European countries and compares two different therapeutic strategies for atrial fibrillation.

EAST demonstrates that independent, investigator initiated studies are essential to gain scientifically relevant knowledge in the clinical research.

Many issues of medical treatment like those studied in EAST would not be investigated in commercial trials.

Again the team of CRI demonstrates its great expertise in design, set-up and  implementation of international “Investigator-Initiated-Trials” (IITs).

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Recruitment for the study “Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servoventilation in patients with heart failure” (SERVE-HF)” was completed on 31.05.2013.

The follow-up period for the 1.325 randomized patients from 10 European countries will be two years.

The CRI Team has mastered the challenge to coordinate two different medical fields (sleep medicine and cardiology) in a parallel randomized trial despite many procedural and logistical challenges.

Experts eagerly await the result of the study.

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Today, the 1000th patient was included into our SERVE-HF study. This controlled clinical endpoint study aims to find out whether patients with central sleep apnea and associated heart failure benefit from a adaptive servo ventilation at home in the long term. Approx. 250 study sites in 9 European countries and Australia are participating in SERVE-HF. 

CRI is the full-service lead CRO and has partnered with an Australian CRO to provide all required services to the project; these include the design of the study protocol and e-CRFs, all regulatory proceedings, management of contracts with study centers and other involved parties, project- and data management as well as monitoring, safety, handling of fees and production of the final report.

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Another major international study project in which CRI acts as a full service CRO, was audited on behalf of the sponsor. Objective of the audit was to assess whether the established processes  comply with the requirements of ICH GCP and applicable legal requirements. We are pleased with the positive evaluation  and the progress of the study.

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Just under 10 months after the opening of the institute, CRI has passed its first GCP audit well. A large international sponsor engaged an independent auditor to evaluate their CRI-conducted project, as well as all relevant procedures at CRI – there was no major complaint. We are pleased with this outcome and feel encouraged to continue on our way.

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After a long search and extensive alterations, CRI has now moved into its new office. The Renaissance House offers a pleasant surrounding combined with modern infrastructure – and excellent connections to the Central Railway Station as well as all to city trains (“S-Bahnen”). Located on the 5th floor, we enjoy an unrestricted view over much of Munich and look straight at the Alps – a panoramic vista that clears the mind for innovative tasks.

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With the participation of 200 study sites across 11 countries, this controlled clinical endpoint study aims to find out, wether patients with atrial fibrillation will benefit from an early rhythm-sustraining treatment in the long term.

Sponsor is the non-profit research network AFNET e.V.
CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

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The Clinical Research Institute with its initially small team has started its operations. The first project contracts have been signed or will be signed soon. To ensure that the Institute will be able to conduct international projects comprehensively and according to industry standards in the near future, it is planned to rapidly grow the CRI team.