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Reporting of study results: a challenge?

Since 2007 there is a legal obligation to report results of registered clinical studies in a timely manner. Now more than 10 years later, how is compliance with this regulation? Problematic, according to a recent publication in the Deutsche Ärzteblatt (Richter-Kuhlmann, E., Deutsches Ärzteblatt | Jg. 117 | Heft 31–32 | 3. August 2020, A1492-A1497). Especially academic centers lag behind when it comes to the reporting of study results. The Cochrane foundation Germany published an analysis in The Lancet, stating that out of 4.200 clinical studies in the (US-based) study register ClinicalTrials.gov [1], for only around 40% results have been communicated.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Dr. Grit Andersen on Apr 6, 2021 4:00:00 PM
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Profil leads the way in establishing audit trail review procedures in clinical studies using visual data analytics

Background

For the last few years, one of the hottest topics in clinical research has been data integrity. An important part of ensuring data integrity - that is now mandated by the authorities - is the structured review of audit trails. Unfortunately, there is little guidance on how to perform such review. As it is virtually impossible to read all lines in an audit trail (and it would not make much sense either), other means of review need to be applied.
The solution for this problem is visual data analytics. We have created an interactive environment that enables the reviewer to dig into the data and learn what actually happened during a study. With this novel approach, audit trail review not only becomes possible, but it actually becomes meaningful.

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Clinical trials in Obesity

Posted by Sascha Heckermann on Mar 8, 2021 4:00:00 PM
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Free Online Seminar: Audit trail review in clinical studies using visual data analytics

Profil continues the successful series of scientific online seminars. On March 23th, 2021 at 4 PM CEST we will air our next free online seminar. The session is presented by Sascha Heckermann, Chief Executive Officer at Profil. 

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Clinical trials in Obesity

Posted by Dr. Lars Bochmann on Feb 23, 2021 4:00:00 PM
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Profil starts in-house production of tubing sets for ClampArt®, reinforcing the quality of world-class glucose clamp trials

The euglycemic, hyperinsulinemic glucose clamp is the gold standard for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of (new) anti-diabetic drugs, in particular insulins. In a typical glucose clamp experiment, a drug-induced decline in blood glucose (BG) concentrations is prevented by infusing glucose with a variable glucose infusion rates (GIR) to keep blood glucose concentrations (BG) as closely as possible to a pre-defined target level. 

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Topics: Clinical Trial Methods, Diabetes Technology

Posted by Dr. Carsten Benesch on Sep 8, 2020 4:02:00 PM
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Bringing the real world to clinical research: the use of wearables in pivotal trials

From fitness trackers and health apps to sophisticated sensors and software that support clinical decision, wearables are reshaping the delivery of health care. The use of wearables allows patients to keep track and take control of their own health and can offer primary care professionals with day-to-day insights of patients’ health conditions, allowing early diagnosis and interventions to take place even outside of traditional care facilities. Wearables allow the collection of real-world data in everyday life settings and can be especially useful to enable a precision medicine approach and optimize treatment of chronic diseases [1].

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Topics: Treating Diabetes, Clinical Trial Methods, Diabetes Technology

Posted by Tatiana Dicenzo on Jun 23, 2020 4:00:00 PM
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Fighting Corona: Profil's contribution

The pandemic of the coronavirus disease (COVID-19) has rapidly changed our lives. Most facilities of daily life are closed, many people try to get accustomed to home-office and in many countries people are gated. Despite all these measures infection rates still rise exponentially in nearly all countries affected. In these times everyone should do their part in fighting the pandemic. 

Profil, a CRO specialized on early phase clinical trials, is stepping up to this responsibility by offering support to companies developing vaccines against COVID-19. As one of the leading phase 1 units in Europe, we can offer experience with Europe's regulatory landscape as well as years of routine in conducting early phase trials in our two clinics in Germany. Combined with our team's previous experience working on novel vaccine developments this allows us to support companies looking for rapid and effective support in their clinical development.

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Topics: About Profil, Clinical Trial Methods

Posted by Dr. Tim Heise on Mar 20, 2020 12:01:27 PM
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Is there a ‘true’ insulin time action profile?

The impact of different study populations in glucose clamp studies

Over the last decade, the euglycemic clamp technique has evolved to the reference method for assessing time action profiles of insulins, and regulatory agencies require glucose clamp trials as part of the clinical development of novel and biosimilar insulin products [1, 2]. Of course the experimental set-up of glucose clamp trials can vary, depending for example on whether a long-acting or a rapid-acting insulin is tested. However, one of the most important decisions when planning glucose clamp trials is the choice of a suitable study population. The choice is between patients with type 1 diabetes, type 2 diabetes, or healthy people. Indeed, healthy volunteers can be the preferable option. Each of these groups comes with their own specific advantages and disadvantages.

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Oliver Klein on Jun 18, 2019 5:21:00 PM
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Applications of iontophoresis in studies investigating microvasculature

People suffering from Diabetes Mellitus can develop both macrovascular and microvascular complications. Retinopathy, nephropathy and neuropathy are the main microvascular complications occurring in Diabetes Mellitus. Mechanisms include structural and functional alterations resulting from chronically elevated glucose concentrations. Therefore, assessment of the microvasculature is important for studies investigating new treatment modalities in diabetes.

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Topics: Clinical Trials in Diabetes, Treating Diabetes, Clinical Trial Methods

Posted by Dr. Jorge Arrubla on Jun 4, 2019 5:21:00 PM
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Are soccer players with dark skin tone more likely to receive red cards?

And why does this matter in drug development?

Statistical analytical methods are often taken for granted. In a recent crowdsourcing data analysis project, Nosek and co-workers found 29 research teams willing to analyze the same dataset [1]. The results varied from positive to neutral. How is this possible and what are the consequences? 

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Topics: Clinical Trial Methods

Posted by Prof. Hans de Vries on Mar 12, 2019 5:11:00 PM
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New data on cardiovascular outcomes with dapagliflozin

Putting effects of SGLT2 inhibitors into perspective

The DECLARE-TIMI 58 trial [1] investigated the effects of treatment with dapagliflozin on cardiovascular outcomes in people with type 2 diabetes in a double blind randomized placebo controlled manner. It is the third published trial investigating cardiovascular outcomes of SGLT2 inhibitors, following EMPA-REG (for empagliflozin) [2] in 2015 and CANVAS (canagliflozin) [3] in 2017. Of these three trials, DECLARE-TIMI 58 has been the largest by a fair margin, including more than 17000 patients with type 2 diabetes who either had multiple risk factors for atherosclerotic cardiovascular disease or established cardiovascular disease.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Oliver Klein on Dec 4, 2018 5:09:00 PM
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