Contact
Header_1077x260px_About_Profil.jpg

Profil World - The clinical diabetes research newsletter - October 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.

Read More

Topics: About Profil

Posted by Maria Andresen on Oct 13, 2021 2:16:34 PM
maria-andresen

Free Online Seminar: Advancements in oral insulin development

Profil continues the successful series of scientific online seminars. On November 2nd, 2021 at 4 PM CEST we will air our next free online seminar. The session is presented by Dr. Eric Zijlstra, Executive Project Director at Profil at Profil:

Read More

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

Posted by Maria Andresen on Oct 5, 2021 4:00:00 PM
maria-andresen

Oral insulin: The future of insulin therapy?

In a review article published in April 2021, Profil’s Lead Scientist Dr. Tim Heise gives an overview on the future of insulin therapy (1).

When thinking of 100 years of insulin treatment since its first use, it is not surprising that one of the topics elaborated on in the article refers to oral insulin. Insulin injections into the subcutaneous tissue are considered inconvenient and could be related with fears and a consecutive time delay in starting an insulin therapy deemed necessary (2). 

Read More

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

Posted by Dr. Sabine Arnolds on Sep 23, 2021 4:00:00 PM
dr-sabine-arnolds

EU Clinical Trials Regulation (EU-CTR) enters application on 31 January 2022

On the 2nd of August 2021 EMA published the start of the countdown to go-live for the Clinical Trials Information System (CTIS) (1). The countdown comprises 6 months and will end on 31 January 2022. As the application of the Clinical Trials Regulation depended on the confirmation of functionality of the clinical trial EU portal and database (one of the key components of CTIS) this confirmation has been long awaited. After announcing the CTR on 16 June 2014 the expectation was that CTIS would be available in December 2015. However, due to technical difficulties the “portal’s go-live date” was delayed several times over the past years, but was now confirmed on 31 July 2021. 

Read More

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

Posted by Dr. Grit Andersen on Aug 9, 2021 4:00:00 PM
dr-grit-andersen

Profil World - The clinical diabetes research newsletter - July 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.

Read More

Topics: About Profil

Posted by Maria Andresen on Jul 12, 2021 9:15:11 AM
maria-andresen

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.

 

Read More

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

Posted by Prof. Dr. Freimut Schliess on Jun 2, 2021 5:00:00 PM
prof-dr-freimut-schliess

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.

Read More

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

Posted by Dr. Sabine Arnolds on May 7, 2021 4:00:00 PM
dr-sabine-arnolds

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:

Read More

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

Posted by Maria Andresen on Apr 22, 2021 4:00:00 PM
maria-andresen

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.

Read More

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
dr-grit-andersen

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.

Read More

Topics: About Profil

Posted by Maria Andresen on Mar 16, 2021 4:00:00 PM
maria-andresen

Subscribe to our monthly blog updates

Find out more: Glucose Clamp Webinar

Subscribe to Email Updates

Our most popular Posts