Table1_Economic impact of industry-sponsored clinical trials in inflammatory bowel diseases: Results from the national institute of gastroenterology “Saverio de Bellis”.XLSX

Introduction: The majority of the money spent on possible new medications’ clinical trials is accounted for by the innovative pharmaceutical sector, which also stimulates the economy of a nation. The objective of this study was to evaluate the impact of pharmaceutical industry-sponsored clinical trials (ISCTs) in inflammatory bowel diseases (IBDs) towards the national health service (NHS) in terms of avoided costs and leverage effect.Methodology: The research was conducted at National Institute of Gastroenterology, “Saverio De Bellis”, Castellana Grotte (Apulia, Italy) collecting data from profit ISCTs of pharmaceutical products conducted over the time period 2018-2020 with focus on inflammatory bowel diseases. After the quantification of health services and drug costs from the latter studies, avoided costs and leverage effects were then estimated.Results: The results on the avoided costs for healthcare facilities deriving from the conduct of clinical studies show that, in relation to the sample of five drug companies participating in our 2018-2020 analysis, out of a total of 235,102.46 €, identified as direct investment, 628,158.21 € of avoided costs for the NHS were measured, with an additional saving (leverage effect) for the NHS of 3.67 € for each € invested by the companies promoting clinical trials.Conclusion: Conducting profit clinical trials has practical benefits and a favourable macroeconomic impact that, by completing its limited resources, helps to sustain one country NHS thanks to the avoided costs while also contributing to locational and industrial policy while guaranteeing novel therapeutics and health services for the patients enrolled.</p

Comparison of peak intensities average (μA) between Breast cancer patients with high BMI and low BMI.

<p>Only significant peaks (P-value<0.01) are reported.</p><p> <b>Legend:</b></p>*<p> = From IMAC 30 Dataset.</p>**<p> = From CM 10 Dataset.</p

Clinicopathological features in a case study of 300 patients affected by breast cancer and 300 control with negative mammography result.

*<p>: χ² test.</p

Comparison of the effect of two TGF-βR inhibitor analogs, LY2109761 and LY2157299, on HCC cell migration on different extracellular matrix components.

<p>(A) HLE and (B) HLF cells were allowed to migrate for 16 hours on fibronectin (Fn), vitronectin (Vn), laminin-5 (Ln-5) and fibrinogen (Fg) in the presence or absence (vehicle) of increasing concentrations of LY2109761 or LY2157299. All conditions were performed in duplicate, and each experiment was repeated at least three times. Results of representative experiments are shown, and values are expressed as mean ± standard deviation.</p

Comparison of peak intensities average (μA) between high BMI breast cancer patients and healthy subjects.

<p>Only significant peaks (P-value<0.01) are reported.</p><p> <b>Legend:</b></p>*<p> = From IMAC 30 Dataset.</p>**<p> = From CM 10 Dataset.</p

Logistic multivariate model with breast cancer as dependent variable.

<p>Logistic multivariate model with breast cancer as dependent variable.</p

BMI and pausal status in 300 subjects affected by breast cancer and 300 control cases.

<p>Mantel – Haenszel χ² p<0.05.</p

Immunofluorescence staining of F-actin and p-FAK in HepG2 and HLE siRNA for Smad-2 and Smad-3 after stimulation with TGF-β.

<p>HepG2 and HLE cells silenced for Smad-2 and Smad-3 were incubated with TGF-β under the same experimental conditions described for migration experiments. Cells were fixed with 4% paraformaldehyde, stained with TRITC-phalloidin and anti-pFAK antibody and examined under a NIKON eclipse E1000 fluorescence microscope. Mag = 600×.</p

Immunofluorescence staining of p-Smad2 in frozen HCC tissues.

<p>Tissues from 30 patients with HCC were stained using an anti-p-Smad2 polyclonal antibody (red) and alpha smooth muscle actin with the monoclonal antibody clone 1A4 (green). In 20 out of 30 HCC tissues (69.0%) positivity for p-Smad2 was obtained; representative cases of p-Smad2-positive (patient #1 and #3) or -negative (patients #7 and #9) tissues are shown.</p

Effect of LY2109761 and LY2157299 on SMAD2 phosphorylation upon TGF-β1.

<p>(A) Two different HCC cell lines HLE and HLF were pretreated for 16 hours with 100 nM of LY2109761 or LY2157299 and then stimulated with 2 ng of TGF-β1 for 30 min. Phosphorylation of SMAD2 was detected in immunoblots using a rabbit polyclonal antibody directed against Phospho-Smad2 (Ser465/467). (B) Effect of LY2109761 and LY2157299 on E-cadherin expression in HLE and HLF. Increasing expression of E-cadherin is observed in HLE and HLF cells after treatment with both inhibitors for 48 hours.</p