Cooperation is something that Scandinavian CRO is extra committed to. Every project run by Scandinavian CRO are a cooperation between different partners; sponsor, investigator, study nurse, project manager, CRA, data manager, statistician etcetera. Some of our projects involves more than this. We would like to briefly describe some of our projects for you. So that you could imagine what Scandinavian CRO could do for your project!
The Nordic MDS group was conducted a clinical study in patients with Myelodysplastic syndrome. Scandinavian CRO was responsible for monitoring of the study to maintain GCP throughout the project. The study is now finished and reported and will be publish soon.
Scandinavian CRO has entered into collaborations with other CRO and have a broad network of partners. All our partners have been evaluated and approved in our vendor qualification process to ensure quality and specific competence. This results in SCRO being able to conduct your clinical trial globally.
CLINICAL STUDY TO HELP OVERWEIGHT CHILDREN
40 million children under five years of age are overweight. 124 million children and adolescents in the world suffer from obesity. This is how the global statistics look today, and there are no signs that the problem will decrease. A large interdisciplinary project coordinated from Uppsala University has looked into how these children can be helped. The project also included a clinical study for which SCRO was responsible.
There are several reasons for this alarming obesity epidemic, including environmental factors, such as sedentary lifestyles, and the supply of energy-efficient food, as well as genetic factors. Obesity in childhood means a high risk of being obese as an adult. Children with obesity, especially severe obesity, have an increased risk of metabolic complications in the form of type 2 diabetes, high blood pressure, high blood lipids, and fatty liver. There is also an impact on quality of life and increased risk of psychiatric problems.
The Beta-JUDO project is a joint venture funded by the European Commission's Seventh Framework Program, FP7-Health. The project was coordinated from Uppsala University with participants from childhood clinics in Uppsala and Salzburg. SCRO has completed the clinical study at the University Children's Hospital in Uppsala and at the state hospital in Salzburg. Children with obesity and children with normal weight have been investigated using, for example, sugar loading, blood sampling, magnetic resonance imaging, genetics and bioinformatics.
– It is a multidisciplinary project, where the results of the study are linked to research on beta cells from the pancreas, explains Anneli Risinger, project manager at SCRO.
The study included 44 children and adolescents, aged 10 to 18, who were obese. The children were randomised, blinded to either the drug Exenatide, which is approved for the treatment of adult subjects with diabetes mellitus type 2, or to placebo. Both groups received lifestyle interventions at the same time. Lifestyle interventions consisted of motivational discussions regarding diet, exercise and supportive psychological treatment. The main parameter was the change in BMI (Body Mass Index) over six months of treatment. The level of obesity in children was assessed by an age-adjusted BMI.
The study started in September 2015 and the last patient left the study a year later. SCRO has evaluated and compiled all data in a stimulating collaboration with researchers at the University Children's Hospital and Uppsala University, which has also acted as sponsor and responsible for the study.
– The study showed positive results. The change in BMI was statistically significantly different between the groups. Weight-wise, the difference means that the children who received Exenatide reduced their weight on average 3.5 kg more than the children who received placebo. This is of great importance, since there are no good anti-obesity drugs for children and adolescents aged 10 to 18 years old, says Catarina Jansson Blixt, SCRO responsible statistician.
"Obesity in childhood means a high risk of being obese as an adult.