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

Principal component analysis (PCA) of total bacterial genera found in feces of subjects.

<p>Score plot of the three principal components (PC) after principal component analysis (PCA) of total bacterial genera (16S rDNA), which were found in the fecal samples of immunoglobulin A nephropathy (IgAN) non progressor (NP) and progressor (P) patients, and healthy controls (HC). 1–16, number of fecal samples for each group of subjects.</p

Principal component analysis (PCA) of volatile organic metabolites found in feces of subjects.

<p>Score plots of the two principal components (PC) after principal component analysis (PCA) of volatile organic metabolites of the fecal (A) and urine (B) samples of immunoglobulin A nephropathy (IgAN) non progressor (NP) and progressor (P) patients, and healthy controls (HC).</p

Fecal levels of free amino acids (FAA) in subjects.

<p>Concentration (mg/kg) of individual free amino acids (FAA) found in the fecal samples of immunoglobulin A nephropathy (IgAN) non progressor (NP) and progressor (P) patients, and healthy controls (HC). Data are the means of three independent experiments and standard deviations, performed in duplicate (<i>n</i> = 6).</p

Fecal cultivable bacteria of the main microbial groups.

<p>Cultivable cells (log cfu/g) found in the fecal samples of immunoglobulin A nephropathy (IgAN) non progressor (NP) and progressor (P) patients, and healthy controls (HC). Data are the means of three independent experiments (<i>n</i> = 3). The top and bottom of the box represent the 75th and 25th percentile of the data, respectively. The top and bottom of the error bars represent the 5th and 95th percentile of the data, respectively. ○, Outliers data. Group student's t-test p-values were also shown.</p

Total and active bacteria found in feces of subjects.

<p>Relative abundance (%) of total (16S rDNA) and metabolically active (16S rRNA) bacteria, which were found at the phylum level in the fecal samples of immunoglobulin A nephropathy (IgAN) non progressor (NP) and progressor (P) patients, and healthy controls (HC).</p

pCS-IS and total cholesterol-FMD correlations.

<p>Graphical representation of the direct correlation between pCS and IS (Fig 5a) and of the inverse correlation between total cholesterol and FMD (Fig 5b). Round and squared points represents T0 and T2 values, respectively. Correlation coefficients and p values are represented in the figure.</p

Study flow diagram.

<p>Graphical study representation, adapted from CONSORT^® 2010 flow diagram, showing the total number of people assessed for eligibility, enrolled, undergoing intervention and analyzed.</p

Improvement of FMD after the nutritional intervention.

<p>FMD measured before (T0) and after (T2) two months of diet intervention with pasta enriched with barley β-glucans. Gender is evidenced with continuous and dotted lines for females and males, respectively. *statistically significant difference (p<0.05).</p

Pasta enriched with beta-glucans lowered LDL and total cholesterol serum levels.

<p>Serum levels of HDL (Fig 2a), LDL (Fig 2b) and total cholesterol (Fig 2c) of healthy subjects before (T0) and after (T2) two months of diet intervention with pasta enriched with barley β- glucans. Statistically significant difference (* p<0.001; $ p<0.05). Graphical representation of data published by De Angelis <i>et al</i>. [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0169635#pone.0169635.ref025" target="_blank">25</a>].</p