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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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54th EASD Annual Meeting – Profil’s contributions to the scientific sessions

Berlin, Germany, 1-5 October 2018

Last week our team joined an exciting and busy 54th EASD Annual Meeting in Berlin. We would like to give you a brief overview about those orals and posters presenting results from clinical trials Profil had been involved in.

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

Posted by Dr. Sabine Arnolds on Oct 10, 2018 4:15:43 PM
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How clinical trial results are distorted by reporting bias

Our perception of clinical trial outcomes may be distorted 

European and national legislation clearly specify the mandatory structure and content of a clinical trial protocol, e.g. for a randomised, controlled phase II human drug study [1-4]. The same applies to the structure and content of a clinical study report [5]. One should assume that a publication of a given clinical trial fulfilling these legal requirements is a high-quality and complete mirror of the trial protocol and the study report. The reality is different. Read on to learn more and discover what measures are being taken by the scientific community to avoid distorting public perception and reporting bias by implementing new rules on publishing results of clinical trials. 

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Apr 13, 2017 5:00:00 PM
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Patient initiated research – How involvement of patients could help improve diabetes research

Background and current status

Patient involvement in clinical research

These days patients are getting a more active role in health care systems. A British Medical Journal article stated public involvement in research should be “second nature” by 2025 [1]. Since 2006 the National Institute for Health Research (NIHR) has been supporting the initiative “INVOLVE” [2] aiming at involving the public and patients to improve health research in the UK. The strategic goals of “INVOLVE” include ensuring that opportunities to engage with research are made visible to the public and seized; that the public’s contribution is valued and required as part of high quality research; and that evidence of what works is collected and disseminated.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Mar 24, 2017 5:41:00 PM
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Federal State Minister visited Profil

North Rhine-Westphalia’s Minister for Innovation, Science and Research, Svenja Schulze, visited  Profil in Neuss  

„Exemplary engagement for a higher quality of life“

In Germany about six million people have diabetes – with an upward trend. In order to make life easier for those concerned, scientists and industry work on further therapeutic improvements. Profil, located in Neuss and Mainz, is one of the institutes that work in this area.   For about 17 years Profil together with the pharmaceutical industry has been working on the development of new drugs for the treatment of diabetes. In addition, Profil actively supports further development of known substances and technologies. To get informed about the current state of diabetes research, Svenja Schulze, Minister for Innovation, Science and Research, in the federal state of North Rhine-Westphalia just visited the prestigious contract research organization.

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Topics: About Profil

Posted by Dr. Sabine Arnolds on Sep 1, 2016 9:30:00 AM
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The longest at-home free-living closed-loop study so far!

International trial shows that 12-week day-and-night unsupervised use of an artificial pancreas system is feasible in adults with type 1 diabetes 

The results of a multicenter randomized, twelve week free-living home trial have just been published in the New England Journal of Medicine [1], involving 24-hour closed loop (Figure) in adults with type 1 diabetes. Profil Germany is proud to have been an integral part of this study.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Sep 18, 2015 10:44:00 AM
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Diabetes Patients get a Voice: Patients will Change Research Priorities

What kind of research would people with diabetes like to see done and how does this compare to actual European diabetes research?

Up to now it has been unclear, which research topics and endpoints patients consider to be relevant for their daily treatment. An analysis of randomized phase II-IV trials showed that only 18% of diabetes related publications looked into patient relevant outcomes [1]. A survey in the US Midwest in 4796 people with diabetes and their relatives evaluated their preferences concerning the design of diabetes trials [2]. Patient-reported outcomes like e.g. death took precedence over surrogate markers (e.g. HbA1C) and studies with a practical design were favored over mechanistic or explanatory studies.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Jun 3, 2015 10:12:00 AM
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On the way to a standardized glucose clamp quality control

Why glucose clamps – and how?

The pharmacokinetic/pharmacodynamic (PK/PD) profiles of novel insulin formulations are commonly assessed by means of either automated or manual glucose clamps (watch the free online seminar to learn more). The metabolic effect of the investigated insulin is characterized by the glucose infusion rate (GIR) needed to keep blood glucose (BG) at a predefined target BG concentration during a hyperinsulinemic euglycemic clamp. In automated clamps BG is measured continuously and GIR is adjusted every minute – GIR adaptations in manual clamps, in contrast, “only” occur every 3-10 minutes. Because of the higher sampling rate the automated glucose clamp technique should have a better control quality compared to manual clamps. In addition, there is no room for bias caused by the clamper, which is theoretically possible with manual clamps due to GIR adjustments in anticipation of a certain PD effect [1].

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Apr 13, 2015 12:00:00 PM
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