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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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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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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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Profil World - The clinical diabetes research newsletter - October 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 Oct 13, 2020 4:30:00 PM
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Free Online Seminar: Profil - the leading CRO for metabolic research

Profil continues the successful series of scientific online seminars. On October 7th, 2020 at 4 PM CEST we will air our free online seminar. The session is presented by Dr. Lars Bochmann, Director Marketing and Business Development at Profil. 

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Topics: About Profil

Posted by Dr. Lars Bochmann on Sep 21, 2020 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - June 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 Jun 2, 2020 3:16:00 PM
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Free Online Seminar on insulin biosimilars

Profil continues the successful series of scientific online seminars. On My 19th, 2020 we will air our free online seminar on insulin biosimilars. The session is presented by Dr. Tim Heise, Lead Scientist and Chairman of the Board of Directors at Profil. 

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Topics: About Profil

Posted by Svenya Meister on Apr 21, 2020 5:12:00 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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