scholarly journals Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e053248
Author(s):  
Sydney Axson ◽  
Michelle M Mello ◽  
Deborah Lincow ◽  
Catherine Yang ◽  
Cary Gross ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Sharing ◽  
Descriptive Analysis ◽  
Product Type ◽  
Company Size ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Fda Approval ◽  
Scientific Innovation ◽  
Multicomponent Data

ObjectivesTo examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.DesignCross-sectional descriptive analysis.Setting and participantsNovel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.Main outcome measuresUsing established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.Results26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91–100) vs 59% (IQR 41–70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88–100) vs 57% (0–100), p=0.01) and better data sharing (median of 100% (IQR 80–100) vs 20% (IQR 20–40), p<0.01). No significant differences were observed by company location or product type.ConclusionsIt was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

scholarly journals Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017917 ◽  
Author(s):  
Jennifer E Miller ◽  
Marc Wilenzick ◽  
Nolan Ritcey ◽  
Joseph S Ross ◽  
Michelle M Mello
Keyword(s):  
Clinical Trial ◽  
Descriptive Analysis ◽  
Drug Level ◽  
Drug Approval ◽  
Securities And Exchange Commission ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Cross Sectional ◽  
Fda Approval ◽  
Approved Drugs

ObjectivesTo define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.DesignCross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.Data sourcesData from over 45 sources, including [email protected], ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.Outcome measuresTrial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.ResultsThe FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.ConclusionsAmong large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress.

scholarly journals Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bassey Edem ◽  
Chukwuemeka Onwuchekwa ◽  
Oghenebrume Wariri ◽  
Esin Nkereuwem ◽  
Oluwatosin O. Nkereuwem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
Descriptive Analysis ◽  
Sub Saharan Africa ◽  
Trial Registration ◽  
Reporting Bias ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Sub Saharan

Abstract Objective Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020. Methods A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis. Results CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018–2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias. Conclusion Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.

scholarly journals Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

Nutrients ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 81
Author(s):  
Hiroharu Kamioka ◽  
Hideki Origasa ◽  
Jun Kitayuguchi ◽  
Kiichiro Tsutani
Keyword(s):  
Clinical Trial ◽  
Cross Sectional Study ◽  
Scientific Basis ◽  
Health Claims ◽  
Selective Reporting ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Notification System ◽  
For Profit ◽  
Trial Protocols

Background: A new type of foods with a health claims notification system, the Foods with Function Claims (FFC), was introduced in Japan in April 2015. This cross-sectional study sought to clarify compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system. Methods: All articles based on clinical trials published on the Consumer Affairs Agency website from 1 July 2018 to 30 June 2021 were reviewed. Items assessed included first author characteristics (for-profit or academia), journal name, year published, journal impact factor in 2020, article language, name of clinical trial registration (CTR), and seven compliance items (Title: T, Participant: P, Intervention: I, Comparison: C, Outcome: O, Study design: S, and Institutional Review Board, IRB). Among studies that conducted CTR, consistency with these seven compliance items was evaluated. Results: Out of 136 studies that met all inclusion criteria, 103 (76%) performed CTR, and CTR was either not performed or not specified for 33 (24%). Compliance between the protocol and the text was high (≥96%) for items P and S, but considerably lower for items T, I, C, O, and IRB (52%, 15%, 13%, 69%, and 27%, respectively). Furthermore, 43% of protocols did not include functional ingredients or food names in items T or I. The total score was 3.7 ± 1.1 pts (out of 7). Conclusions: Some CTs had no protocol registration, and even registered protocols were suboptimal in transparency. In addition to selective reporting, a new problem identified was that the content of the intervention (test food) was intentionally concealed.

scholarly journals A body shape index is associated with endothelial dysfunction in both men and women

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Masato Kajikawa ◽  
Tatsuya Maruhashi ◽  
Shinji Kishimoto ◽  
Takayuki Yamaji ◽  
Takahiro Harada ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Endothelial Dysfunction ◽  
Endothelial Function ◽  
Cardiovascular Events ◽  
Body Shape ◽  
Shape Index ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Men And Women ◽  
A Body Shape Index

AbstractA body shape index (ABSI) was proposed for estimation of abdominal adiposity. ABSI has been reported to have associations with cardiovascular risk factors and cardiovascular events. However, there is no information on the association between ABSI and endothelial function. We examined cross-sectional associations of ABSI with endothelial function in 8823 subjects (6773 men and 2050 women). Subjects with a lower quartile of flow-mediated vasodilation (FMD) were defined as subjects having endothelial dysfunction. Pearson’s correlation coefficient analysis revealed that ABSI was negatively correlated with FMD (men, r = − 0.23, P = 0.003; women, r = − 0.32, P < 0.001). The areas under the curves of ABSI and body mass index to predict endothelial dysfunction were 0.64 (95% confidence interval [CI] 0.62–0.65) and 0.58 (95% CI 0.57–0.60) in men, and 0.68 (95% CI 0.66–0.71) and 0.59 (95% CI 0.56–0.61) in women, respectively. The cutoff values of ABSI for predicting subjects with endothelial dysfunction were 0.0796 (sensitivity, 55.2%; specificity, 65.5%) in men and 0.0823 (sensitivity, 56.2%; specificity, 73.4%) in women. Multivariate analysis revealed that an ABSI value higher than the cutoff value remained an independent predictor of endothelial dysfunction in both sexes. The results of our study suggest that ABSI calculation should be performed for evaluation of risk of cardiovascular events in both men and women.Clinical trial registration information URL for Clinical Trial: https://www.umin.ac.jp/ctr/index.htm; Registration Number for Clinical Trial: UMIN000012952 (01/05/2010).

scholarly journals Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices

BMJ ◽  
2019 ◽  
pp. l4217 ◽  
Author(s):  
Jennifer Miller ◽  
Joseph S Ross ◽  
Marc Wilenzick ◽  
Michelle M Mello
Keyword(s):  
Clinical Trial ◽  
Data Sharing ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Interquartile Range ◽  
Pharmaceutical Companies ◽  
Cross Sectional ◽  
New Drug ◽  
Results Reporting ◽  
Policies And Practices

Abstract Objectives To develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial data sharing policies and practices. Design Cross sectional descriptive analysis. Setting Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. Data sources Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. Main outcome measures Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. Results Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. Conclusions It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study’s measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.

scholarly journals Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
pp. 384 ◽  
Author(s):  
Vinay K Rathi ◽  
Kelly M Strait ◽  
Cary P Gross ◽  
Iain Hrynaszkiewicz ◽  
Steven Joffe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Sharing ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Exploratory Analysis ◽  
Cross Sectional Survey ◽  
Cross Sectional

scholarly journals COVID-19-related research in Africa: a cross-sectional review of the International Clinical Trial Registration Platform (ICTRP)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bassey Edem ◽  
Victor Williams ◽  
Chukwuemeka Onwuchekwa ◽  
Ama Umesi ◽  
Marianne Calnan
Keyword(s):  
Scientific Evidence ◽  
Descriptive Analysis ◽  
Cross Sectional Study ◽  
Treatment Modalities ◽  
African Continent ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Related Research ◽  
A Site ◽  
Clinical Trials Registry

Abstract Objective The declaration of the coronavirus disease (COVID-19), a pandemic in early 2020, has seen an upsurge in research globally to fill gaps in the epidemiology of the SARS-CoV-2 virus impact on health care and clinical management, as well as possible prevention and treatment modalities. Published literature on the different types of COVID-19 research conducted globally is varied and is particularly limited in Africa. This study sets out to describe the COVID-19-related research registered and conducted on the African continent. Methods This is a cross-sectional study of all COVID-19-related studies available in the WHO’s International Clinical Trials Registry Platform (ICTRP) repository. We extracted studies registered from March 1, 2020, to July 15, 2021. A descriptive analysis of the extracted data was performed, and the findings were presented. Results At extraction, a total of 12,533 COVID-19-related studies were listed on the ICTRP portal. We included 9803 studies, after excluding 2060 duplicate records and 686 records without a site/country. While 9347 studies (96%) were conducted outside of Africa, only 456 studies (4%) were conducted in the African continent, of which 270 (59.2%) were interventional studies, and 184 (40.4%) were observational studies. About 80% of the studies were conducted in Egypt and South Africa, and most of these involved testing of drugs and biologicals. Conclusion The African continent hosts considerably fewer COVID-19-related research compared to other parts of the world. This may have implications on scientific evidence available for implementing COVID-19 control efforts. There is, therefore, a need for local funding and ownership of research projects and north-south collaboration in research.

scholarly journals Muscle MRI in patients with dysferlinopathy: pattern recognition and implications for clinical trials

2018 ◽  
Vol 89 (10) ◽  
pp. 1071-1081 ◽  
Author(s):  
Jordi Diaz-Manera ◽  
Roberto Fernandez-Torron ◽  
Jaume LLauger ◽  
Meredith K James ◽  
Anna Mayhew ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
The Body ◽  
Quantitative Mri ◽  
Muscle Pathology ◽  
Functional Tests ◽  
Clinical Trial Registration ◽  
Muscle Mri ◽  
Cross Sectional ◽  
Muscle Involvement

Background and objectiveDysferlinopathies are a group of muscle disorders caused by mutations in the DYSF gene. Previous muscle imaging studies describe a selective pattern of muscle involvement in smaller patient cohorts, but a large imaging study across the entire spectrum of the dysferlinopathies had not been performed and previous imaging findings were not correlated with functional tests.MethodsWe present cross-sectional T1-weighted muscle MRI data from 182 patients with genetically confirmed dysferlinopathies. We have analysed the pattern of muscles involved in the disease using hierarchical analysis and presented it as heatmaps. Results of the MRI scans have been correlated with relevant functional tests for each region of the body analysed.ResultsIn 181 of the 182 patients scanned, we observed muscle pathology on T1-weighted images, with the gastrocnemius medialis and the soleus being the most commonly affected muscles. A similar pattern of involvement was identified in most patients regardless of their clinical presentation. Increased muscle pathology on MRI correlated positively with disease duration and functional impairment.ConclusionsThe information generated by this study is of high diagnostic value and important for clinical trial development. We have been able to describe a pattern that can be considered as characteristic of dysferlinopathy. We have defined the natural history of the disease from a radiological point of view. These results enabled the identification of the most relevant regions of interest for quantitative MRI in longitudinal studies, such as clinical trials.Clinical trial registrationNCT01676077.

Sign in / Sign up

Export Citation Format

Share Document