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. 

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.

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:

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.

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.

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. 

The euglycemic, hyperinsulinemic glucose clamp is the gold standard for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of (new) anti-diabetic drugs, in particular insulins. In a typical glucose clamp experiment, a drug-induced decline in blood glucose (BG) concentrations is prevented by infusing glucose with a variable glucose infusion rates (GIR) to keep blood glucose concentrations (BG) as closely as possible to a pre-defined target level. 

From fitness trackers and health apps to sophisticated sensors and software that support clinical decision, wearables are reshaping the delivery of health care. The use of wearables allows patients to keep track and take control of their own health and can offer primary care professionals with day-to-day insights of patients’ health conditions, allowing early diagnosis and interventions to take place even outside of traditional care facilities. Wearables allow the collection of real-world data in everyday life settings and can be especially useful to enable a precision medicine approach and optimize treatment of chronic diseases [1].

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.

The impact of different study populations in glucose clamp studies

Over the last decade, the euglycemic clamp technique has evolved to the reference method for assessing time action profiles of insulins, and regulatory agencies require glucose clamp trials as part of the clinical development of novel and biosimilar insulin products [1, 2]. Of course the experimental set-up of glucose clamp trials can vary, depending for example on whether a long-acting or a rapid-acting insulin is tested. However, one of the most important decisions when planning glucose clamp trials is the choice of a suitable study population. The choice is between patients with type 1 diabetes, type 2 diabetes, or healthy people. Indeed, healthy volunteers can be the preferable option. Each of these groups comes with their own specific advantages and disadvantages.