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Can Remote Decentralised Clinical Trials enhance clinical research?

A Remote Decentralised Clinical Trial (RDCT) design can be a valuable option to make your clinical trial more efficient. Also called web-based or hybrid trials, they combine digital technologies with more “conventional” design elements to bring clinical research to patients’ homes [1]. RDCTs democratize the access to clinical trials by reaching population groups that would normally not have the possibility to enrol in a clinical trial. Web-based communication paths facilitate the participation of elderly, frail, disable people and people living in remote areas.

RDCTs may help achieving higher levels of sustainability, resilience and external validity in pivotal clinical research.

 

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Jun 2, 2021 5:00:00 PM
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Gender ratio in clinical trials – are there less female trial participants?

One of the aspects to consider when designing clinical trials, and often a quite controversial one, is the ratio of male and female study participants. There are a number of criteria that can have an effect on the ideal or actual gender distribution for a study.

In this article we review the legal situation, typical gender distribution in published studies, Profil’s considerations for our own studies as well as other aspects important when planning an early phase trial.

What is the legal framework?

The conduct of clinical trials with investigational medicinal products is subject to strict legal requirements.
Since 1993 the US Food and Drug Administration (FDA) has demanded that both genders are included in clinical trials [1] – the determination of potential gender differences within clinical studies was prescribed by law in the EU in 2001 and in Germany in 2004 [2, 3]. Good Clinical Practice (GCP) requires a justification for the chosen gender distribution [4].
A restriction in early phase clinical studies is that only the inclusion of post-menopausal or surgically sterilized women is allowed [5, 6]. Pregnant and lactating women as well as children and adolescents rank among vulnerable groups – special safety precautions are in place for them, limiting possible study participation (5).
In preclinical research however, the use of animals of both sexes is required in order to generate data with the highest possible predictive value for human use [7].

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Topics: Clinical Trials in Diabetes, About Profil, Clinical Trial Methods

Posted by Dr. Sabine Arnolds on May 7, 2021 4:00:00 PM
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Free Online Seminar: IMP manufacturing services for clinical trials in EU

Profil continues the successful series of scientific online seminars. On May 18th, 2021 at 4 PM CEST we will air our next free online seminar. The session is presented by Parisa Mozaffari, Qualified Person and Head of IMP at Profil:

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Topics: Clinical Trials in Diabetes, About Profil, Clinical Trial Methods

Posted by Maria Andresen on Apr 22, 2021 4:00:00 PM
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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 World - The clinical diabetes research newsletter - March 2021

Dear all,

Greetings from Germany! I am happy to share with you the newest edition of "Profil World" - our newsletter filled with information about clinical research in diabetes and obesity.

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Topics: About Profil

Posted by Maria Andresen on Mar 16, 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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Can serious games motivate teenagers with diabetes to adhere to their treatment?

Serious games are video games or digital games designed to promote educational content or behaviour changes rather than serving as pure entertainment. They could be a powerful tool to improve treatment adherence in teenagers with a chronic condition.

Type 1 Diabetes is one of the most common metabolic disorders affecting children and adolescents, and its worldwide incidence continues to increase [1]. Despite all the advancements in diabetes treatment, treating teenagers with diabetes type 1 remains a challenge.

Multiple factors such as increased insulin resistance, hormonal changes, changes in body composition and a lifestyle that is less regular (eating and exercise habits) play a role in the worsening of metabolic control during adolescence. The transition of therapy responsibility from parents to their growing children also contributes to a decrease in the frequency of self-testing blood glucose and adherence to therapy after teenagers start self-managing their diabetes. Adherence to treatment is crucial to achieve better therapeutic outcomes, especially when treating chronic diseases. However, adherence rates [2] among patients with chronic conditions tend to be much lower than amongst patients with acute conditions and teenagers need an even higher level of motivation to adhere to their treatment scheme.

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Topics: Treating Diabetes

Posted by Tatiana Dicenzo on Feb 9, 2021 4:15:00 PM
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Running clinical trials at Profil during pandemic times

Impact of COVID-19 on clinical trials

In December 2019, China was affected by several cases of what was considered a fatal viral pneumonia (1). The numbers of affected patients were exponentially increasing and on January 9th 2020 Chinese authorities made a preliminary determination of a novel coronavirus which became known as SARS-CoV-2 or COVID-19 (1). Not long after, on January 30th 2020 the World Health Organisation (WHO) declared the COVID-19 outbreak as a global emergency (2). This was just the beginning of a pandemic that has come to challenge all what we thought to be normal and forced us to adapt to a new reality - a new lifestyle. This new reality has also affected clinical research as resources given to human trials were diverted towards the pandemic response resulting in the termination, suspension or withdrawal of more than 1700 clinical trials worldwide (3). In addition, most of the ongoing studies have undergone substantial modifications in order to address the safety of participants, staff and investigators (4) and here at Profil we are proud to be at the forefront of finding answers to these new challenges.

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Topics: Clinical Trials in Diabetes, About Profil

Posted by Javiera Villagra on Jan 7, 2021 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - December 2020

Dear all,

Greetings from Germany! I am happy to share with you the newest edition of "Profil World" - our newsletter filled with information about clinical research in diabetes and obesity.

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Topics: About Profil

Posted by Dr. Lars Bochmann on Dec 17, 2020 10:19:00 AM
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