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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
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.

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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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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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Once-weekly basal insulin analogue in clinical development

Once-weekly basal insulin icodec treatment may offer more convenience in people with type 2
diabetes and may improve outcomes.

Molecular and biological properties of once-weekly insulin icodec and promising phase 1 and 2 data
were presented at American Diabetes Association’s 80th Scientific Sessions and 56th European
Association for the Study of Diabetes (EASD) Annual Meeting 2020.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Nov 17, 2020 4:00:00 PM
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The rollercoaster life of inhaled insulin

From Nektar’s award-winning technology to its later commercial failure as Pfizer’s Exubera®. Followed by new hopes for Mannkind’s Afrezza® that suffered more commercial disappointment [1,2,3,4]. The life of pulmonary delivery of insulin (inhaled insulin) has been a thrilling rollercoaster ride. Experts have openly asked whether inhaled insulin has come to the end of its ride or whether there is still a place for inhaled insulin in the future [5]. In this blog article on inhaled insulin, we’ll have a look at what the future may look like and discuss the latest advances with a novel inhaled insulin.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Eric Zijlstra on Aug 4, 2020 4:15:00 PM
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Heart failure: SGLT2 inhibitors moving beyond diabetes

Sodium/glucose cotransporter 2 (SGLT2) inhibitors have gained momentum in the last few years due to their therapeutic effectivity and the potential to reduce cardiovascular (CV) risks in type 2 diabetes [1, 2, 3].

The mechanisms involved in the improved risk profile observed seem to be a combination of several factors, including blood pressure reduction, increased sodium excretion, weight reduction and improved heart function [4].

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Jul 14, 2020 4:15:00 PM
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Non invasive CGM; hope at the horizon?

Non-invasive Continuous Glucose Monitoring (niCGM) is the holy grail of glucose monitoring. But the quest has been arduous so far; research carried out over the past 35 years has not resulted in in a device with durable availability on the market [1, accessed March 23, 2020].

Two devices have briefly been commercially available. The first, called GlucoWatch Biographer, has been for sale from 2002 to 2007. Poor local tolerability and low accuracy were the limiting factors. The device applied a low voltage current to obtain interstitial fluid transcutaneously. Skin irritation, probably inherent to this technique, together with insufficient accuracy, resulted in withdrawal from the market and dissolvement of the manufacturer [2].

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Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Prof. Hans de Vries on May 6, 2020 4:17:00 PM
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