scholarly journals A dashboard for exploring clinical trials sponsorship and potential virtual monopolies

JAMIA Open ◽  
2021 ◽  
Vol 4 (4) ◽  
Author(s):  
S Scott Graham ◽  
Zoltan P Majdik ◽  
Joshua B Barbour ◽  
Justin F Rousseau
Keyword(s):  
Clinical Trials ◽  
Data Interpretation ◽  
The United States ◽  
Directed Network ◽  
Mapping Algorithms ◽  
Drug Prices ◽  
R Shiny ◽  
Advance Research ◽  
Network Mapping ◽  
Shiny Application

Abstract Objective To create a data visualization dashboard to advance research related to clinical trials sponsorship and monopolistic practices in the pharmaceuticals industry. Materials and Methods This R Shiny application aggregates data from ClinicialTrials.gov resulting from user’s queries by terms. Returned data are visualized through an interactive dashboard. Results The Clinical Trials Sponsorship Network Dashboard (CTSND) uses force-directed network mapping algorithms to visualize clinical trials sponsorship data. Interpretation of network visualization is further supported with data on sponsor classes, sponsorship timelines, evaluated products, and target conditions. The source code for the CTSND is available at https://github.com/sscottgraham/ConflictMetrics. Discussion Monopolistic practices have been identified as a likely contributor to high drug prices in the United States. CTSND data and visualizations support the analysis of clinical trials sponsorship networks and may aid in identifying current and emerging monopolistic practices. Conclusions CTSND data can support more robust deliberation about an understudied area of drug pricing.

Developing a Clinical Trials Infrastructure in the United States

2012 ◽  
Vol 2 (5) ◽  
Author(s):  
Paul Eisenberg ◽  
◽  
Petra Kaufmann ◽  
Ellen Sigal ◽  
Janet Woodcock ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

scholarly journals 690 Are participants in obstetrical randomized clinical trials representative of the United States pregnant population?

2021 ◽  
Vol 224 (2) ◽  
pp. S433
Author(s):  
Cynthia Coots ◽  
Stephen Wagner ◽  
Matthew J. Bicocca ◽  
Megha Gupta ◽  
Hector Mendez Figueroa ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
The United States

scholarly journals Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder

2021 ◽  
pp. 002216782110236
Author(s):  
Julie B. Wang ◽  
Jessica Lin ◽  
Leah Bedrosian ◽  
Allison Coker ◽  
Ilsa Jerome ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Clinical Trials ◽  
Posttraumatic Stress ◽  
Clinical Supervision ◽  
Stress Disorder ◽  
The United States ◽  
Health Condition ◽  
Open Label ◽  
Adverse Health Outcomes ◽  
Ptsd Symptom Severity

Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites. Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity. Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p < .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated. Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.

Parallel Network Mapping Algorithms

2021 ◽  
Author(s):  
Ramtin Afshar ◽  
Michael T. Goodrich ◽  
Pedro Matias ◽  
Martha C. Osegueda
Keyword(s):  
Mapping Algorithms ◽  
Parallel Network ◽  
Network Mapping

scholarly journals Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

2021 ◽  
Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Supportive Care ◽  
The United States ◽  
Primary Objective ◽  
Point Prevalence ◽  
Medical Centers ◽  
Academic Medical ◽  
History Of ◽  
Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P &lt; 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

scholarly journals EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii79-ii79
Author(s):  
Kathryn Nevel ◽  
Samuel Capouch ◽  
Lisa Arnold ◽  
Katherine Peters ◽  
Nimish Mohile ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Rural Communities ◽  
The United States ◽  
Interventional Treatment ◽  
Phase Ii Trials ◽  
Treatment Trials ◽  
Rural Sites ◽  
Rural Patients ◽  
Urban Sites

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p&lt; 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

Industry Payments to Plastic Surgeons: What Has Changed Over the Last Six-Years Following Implementation of the Physician Payment Sunshine Act?

2021 ◽  
Author(s):  
Rowland W Pettit ◽  
Jordan Kaplan ◽  
Matthew M Delancy ◽  
Edward Reece ◽  
Sebastian Winocour ◽  
...  
Keyword(s):  
United States ◽  
User Interface ◽  
Stock Options ◽  
Data Interpretation ◽  
The United States ◽  
Inclusion Criteria ◽  
Physician Payment ◽  
The Past ◽  
To Receive ◽  
Open Payments

Abstract Background The Open Payments Program, as designated by the Physician Payments Sunshine Act is the single largest repository of industry payments made to licensed physicians within the United States. Though sizeable in its dataset, the database and user interface are limited in their ability to permit expansive data interpretation and summarization. Objectives We sought to comprehensively compare industry payments made to plastic surgeons with payments made to all surgeons and all physicians to elucidate industry relationships since implementation. Methods The Open Payments Database was queried between 2014 and 2019, and inclusion criteria were applied. These data were evaluated in aggregate and for yearly totals, payment type, and geographic distribution. Results 61,000,728 unique payments totaling $11,815,248,549 were identified over the six-year study period. 9,089 plastic surgeons, 121,151 surgeons, and 796,260 total physicians received these payments. Plastic surgeons annually received significantly less payment than all surgeons (p=0.0005). However, plastic surgeons did not receive significantly more payment than all physicians (p = 0.0840). Cash and cash equivalents proved to be the most common form of payment; Stock and stock options were least commonly transferred. Plastic surgeons in Tennessee received the most in payments between 2014-2019 (mean $ 76,420.75). California had the greatest number of plastic surgeons to receive payments (1,452 surgeons). Conclusions Plastic surgeons received more in industry payments than the average of all physicians but received less than all surgeons. The most common payment was cash transactions. Over the past six years, geographic trends in industry payments have remained stable.

scholarly journals Recent Findings on Cell-Based Therapies for COVID19-Related Pulmonary Fibrosis

2021 ◽  
Vol 30 ◽  
pp. 096368972199621
Author(s):  
Hong-Meng Chuang ◽  
Li-Ing Ho ◽  
Horng-Jyh Harn ◽  
Ching-Ann Liu
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Pulmonary Fibrosis ◽  
Tissue Repair ◽  
Immune Modulation ◽  
Distress Syndrome ◽  
Clinical Symptoms ◽  
The United States ◽  
Past Experiences ◽  
Respiratory Tract Inflammation

COVID-19 has spread worldwide, including the United States, United Kingdom, and Italy, along with its site of origin in China, since 2020. The virus was first found in the Wuhan seafood market at the end of 2019, with a controversial source. The clinical symptoms of COVID-19 include fever, cough, and respiratory tract inflammation, with some severe patients developing an acute and chronic lung injury, such as acute respiratory distress syndrome (ARDS) and pulmonary fibrosis (PF). It has already claimed approximately 300 thousand human lives and the number is still on the rise; the only way to prevent the infection is to be safe till vaccines and reliable treatments develop. In previous studies, the use of mesenchymal stem cells (MSCs) in clinical trials had been proven to be effective in immune modulation and tissue repair promotion; however, their efficacy in treating COVID-19 remains underestimated. Here, we report the findings from past experiences of SARS and MSCs, and how SARS could also induce PF. Such studies may help to understand the rationale for the recent cell-based therapies for COVID-19.

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