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Article ; Online: Regulatory considerations to keep pace with innovation in digital health products

John Torous / Ariel D. Stern / Florence T. Bourgeois

npj Digital Medicine, Vol 5, Iss 1, Pp 1-

2022 Volume 4

Abstract: Abstract Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical ...

Abstract	Abstract Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The automation of relevant trial registration screening for systematic review updates

Didi Surian / Florence T. Bourgeois / Adam G. Dunn

BMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-

an evaluation study on a large dataset of ClinicalTrials.gov registrations

2021 Volume 10

Abstract: Abstract Background Clinical trial registries can be used as sources of clinical evidence for systematic review synthesis and updating. Our aim was to evaluate methods for identifying clinical trial registrations that should be screened for inclusion in ... ...

Abstract	Abstract Background Clinical trial registries can be used as sources of clinical evidence for systematic review synthesis and updating. Our aim was to evaluate methods for identifying clinical trial registrations that should be screened for inclusion in updates of published systematic reviews. Methods A set of 4644 clinical trial registrations (ClinicalTrials.gov) included in 1089 systematic reviews (PubMed) were used to evaluate two methods (document similarity and hierarchical clustering) and representations (L2-normalised TF-IDF, Latent Dirichlet Allocation, and Doc2Vec) for ranking 163,501 completed clinical trials by relevance. Clinical trial registrations were ranked for each systematic review using seeding clinical trials, simulating how new relevant clinical trials could be automatically identified for an update. Performance was measured by the number of clinical trials that need to be screened to identify all relevant clinical trials. Results Using the document similarity method with TF-IDF feature representation and Euclidean distance metric, all relevant clinical trials for half of the systematic reviews were identified after screening 99 trials (IQR 19 to 491). The best-performing hierarchical clustering was using Ward agglomerative clustering (with TF-IDF representation and Euclidean distance) and needed to screen 501 clinical trials (IQR 43 to 4363) to achieve the same result. Conclusion An evaluation using a large set of mined links between published systematic reviews and clinical trial registrations showed that document similarity outperformed hierarchical clustering for identifying relevant clinical trials to include in systematic review updates.
Keywords	Systematic reviews ; Trial registrations ; Document similarity ; Hierarchical clustering ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A systematic review of the processes used to link clinical trial registrations to their published results

Rabia Bashir / Florence T. Bourgeois / Adam G. Dunn

Systematic Reviews, Vol 6, Iss 1, Pp 1-

2017 Volume 17

Abstract: Abstract Background Studies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links. ... ...

Abstract	Abstract Background Studies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links. Methods PubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration identifier was available in the bibliographic database or publication, or manual when linkage required inference or contacting of trial investigators. The number of links identified by each process was extracted where available. Linear regression was used to determine whether the proportions of links available via automatic processes had increased over time. Results In 43 studies that examined cohorts of registry entries, 24 used automatic and manual processes to find articles; 3 only automatic; and 11 only manual (5 did not specify). Twelve studies reported results for both manual and automatic processes and showed that a median of 23% (range from 13 to 42%) included automatic links to articles, while 17% (range from 5 to 42%) of registry entries required manual processes to find articles. There was no evidence that the proportion of registry entries with automatic links had increased (R 2 = 0.02, p = 0.36). In 39 studies that examined cohorts of articles, 21 used automatic and manual processes; 9 only automatic; and 2 only manual (7 did not specify). Sixteen studies reported numbers for automatic and manual processes and indicated that a median of 49% (range from 8 to 97%) of articles had automatic links to registry entries, and 10% (range from 0 to 28%) required manual processes to find registry entries. There was no evidence that the proportion of articles with automatic links to registry entries had increased (R 2 = 0.01, p = 0.73). Conclusions The linkage of trial registries to their corresponding publications continues to ...
Keywords	Clinical trials as topic ; Trial registration ; Publication bias ; Reporting bias ; Systematic reviews as topic ; Medicine ; R
Subject code	001
Language	English
Publishing date	2017-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union

Thomas J Hwang / Paolo A Tomasi / Florence T Bourgeois

PLoS Medicine, Vol 15, Iss 3, p e

A cohort study.

2018 Volume 1002520

Abstract: BACKGROUND:Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct ... ...

Abstract	BACKGROUND:Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU. METHODS AND FINDINGS:The European Medicines Agency (EMA) public database of paediatric investigation plans was searched for new medicines centrally authorised in the EU between 1 January 2010 and 31 December 2014 with at least 1 required paediatric study. For our study cohort of paediatric clinical trials required for these medicines, we used internal EMA databases and publicly available trial registries to determine changes to the planned completion date or study design, rates of trial completion, time to trial completion, and results reporting (peer-reviewed publication or posting on trial registry). Cox proportional hazards regression models were constructed to examine factors associated with study completion. A total of 326 paediatric clinical trials were required for 122 novel medicines authorised by the EMA between 2010 and 2014. In all, 76% (247/326) of paediatric studies were not planned to be completed until after the initial marketing authorisation. The planned completion dates for 50% (162/326) were further postponed by a median of 2.2 years. Overall, 38% (124/326) of paediatric studies were completed as of 30 November 2017. The rate of trial completion for paediatric studies planned to be completed after initial marketing authorisation was 23% (56/247), versus 86% (68/79) for trials planned to be completed before authorisation (adjusted hazard ratio 0.11; 95% CI 0.06-0.19). Among completed studies, the results were reported in a public registry or in the peer-reviewed literature for 85% (105/124) at a median of 1.1 years after study ...
Keywords	Medicine ; R
Language	English
Publishing date	2018-03-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prescription opioid use and misuse among adolescents and young adults in the United States

Joel D Hudgins / John J Porter / Michael C Monuteaux / Florence T Bourgeois

PLoS Medicine, Vol 16, Iss 11, p e

A national survey study.

2019 Volume 1002922

Abstract: BACKGROUND:Prescription opioid misuse has become a leading cause of unintentional injury and death among adolescents and young adults in the United States. However, there is limited information on how adolescents and young adults obtain prescription ... ...

Abstract	BACKGROUND:Prescription opioid misuse has become a leading cause of unintentional injury and death among adolescents and young adults in the United States. However, there is limited information on how adolescents and young adults obtain prescription opioids. There are also inadequate recent data on the prevalence of additional drug abuse among those misusing prescription opioids. In this study, we evaluated past-year prevalence of prescription opioid use and misuse, sources of prescription opioids, and additional substance use among adolescents and young adults. METHODS AND FINDINGS:This was a retrospective analysis of the National Survey on Drug Use and Health (NSDUH) for the years 2015 and 2016. Prevalence of opioid use, misuse, use disorder, and additional substance use were calculated with 95% confidence intervals (CIs), stratified by age group and other demographic variables. Sources of prescription opioids were determined for respondents reporting opioid misuse. We calculated past-year prevalence of opioid use and misuse with or without use disorder, sources of prescription opioids, and prevalence of additional substance use. We included 27,857 adolescents (12-17 years of age) and 28,213 young adults (18-25 years of age) in our analyses, corresponding to 119.3 million individuals in the extrapolated national population. There were 15,143 respondents (27.5% [95% CI 27.0-28.0], corresponding to 32.8 million individuals) who used prescription opioids in the previous year, including 21.0% (95% CI 20.4-21.6) of adolescents and 32.2% (95% CI 31.4-33.0) of young adults. Significantly more females than males reported using any prescription opioid (30.3% versus 24.8%, P < 0.001), and non-Hispanic whites and blacks were more likely to have had any opioid use compared to Hispanics (28.9%, 28.1%, and 25.8%, respectively; P < 0.001). Opioid misuse was reported by 1,050 adolescents (3.8%; 95% CI 3.5-4.0) and 2,207 young adults (7.8%; 95% CI 7.3-8.2; P < 0.001). Male respondents using opioids were more likely to ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2019-11-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Noncompletion and nonpublication of trials studying rare diseases

Chris A Rees / Natalie Pica / Michael C Monuteaux / Florence T Bourgeois

PLoS Medicine, Vol 16, Iss 11, p e

A cross-sectional analysis.

2019 Volume 1002966

Abstract: Background Rare diseases affect as many as 60 million people in the United States and Europe. However, most rare diseases lack effective therapies and are in critical need of clinical research. Our objective was to determine the frequency of ... ...

Abstract	Background Rare diseases affect as many as 60 million people in the United States and Europe. However, most rare diseases lack effective therapies and are in critical need of clinical research. Our objective was to determine the frequency of noncompletion and nonpublication of trials studying rare diseases. Methods and findings We conducted a cross-sectional analysis of randomized clinical trials studying rare diseases as defined by the Genetic and Rare Disease Information Center database that were registered in ClinicalTrials.gov between January 1, 2010, and December 31, 2012, and completed or discontinued by December 31, 2014. Our main outcome measures were the frequency of trial noncompletion and, among completed studies, frequency of trial nonpublication at 2 and 4 years following trial completion. Reasons for discontinuation were extracted from the registry, and trial sponsors were contacted for additional information, as needed. Two independent investigators performed publication searches for each trial in PubMed, EMBASE, and GoogleScholar, allowing for a minimum of 45 months between trial completion and publication. When a publication could not be identified, trial sponsors were contacted to confirm publication status. The impact of funding source on trial noncompletion was assessed with multivariable logistic regression, and the effect on time to publication was examined with Cox proportional hazards regression. Control variables included intervention type, trial phase, masking, enrollment, and study population. We analyzed 659 rare disease trials accounting for 70,305 enrolled patients. Industry was the primary funder for 327 trials (49.6%) and academic institutions for 184 trials (27.9%). There were 79 trials (12.0%) focused on pediatric populations. A total of 199 trials (30.2%) were discontinued. Lack of patient accrual (n = 64, 32.1%) and informative termination (n = 41, 20.6%) were the most common reasons for trial noncompletion. Among completed trials, 306 (66.5%) remained unpublished at 2 years ...
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2019-11-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The use of opioids in low acuity pediatric trauma patients.

Ashley A Foster / John J Porter / Florence T Bourgeois / Rebekah Mannix

PLoS ONE, Vol 14, Iss 12, p e

2019 Volume 0226433

Abstract: OBJECTIVE:To describe temporal trends and factors associated with opioid administration among children discharged from the emergency department (ED) after a trauma visit. METHODS:This was a cross-sectional study of ED visits for children <19 years old ... ...

Abstract	OBJECTIVE:To describe temporal trends and factors associated with opioid administration among children discharged from the emergency department (ED) after a trauma visit. METHODS:This was a cross-sectional study of ED visits for children <19 years old who received a trauma-related diagnosis and were discharged from the ED. Data were obtained from the National Hospital Ambulatory Medical Care Survey 2006-2015. OUTCOME MEASURES:Administration of an opioid medication either during the ED visit or as a discharge prescription. Survey-adjusted regression analyses were used to determine the probability of a patient receiving an opioid medication. RESULTS:During the study period, there were 19,241 pediatric trauma visits discharged from the ED, of which 14% were associated with an opioid. Opioid administration decreased by nearly 30% during the study period (p<0.001 for trend). In multivariable analysis, patient factors associated with opioid administration were adolescent age, evening visit, region of the country, and severe pain score. The diagnosis associated with the most opioids was ankle sprain and the diagnosis with the highest rate of opioid administration was radius fracture. The most common opioid administered to children under 12 years of age was acetaminophen-codeine. CONCLUSIONS:Opioid administration appears to be decreasing among pediatric patients presenting to the ED with trauma, but a high number of children continue to be exposed to opioids every year. Further education on opioid sparing pain management strategies may be warranted to decrease opioid exposure, including the inappropriate use of codeine, in this low risk trauma population.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Neglected tropical diseases in children

Chris A Rees / Peter J Hotez / Michael C Monuteaux / Michelle Niescierenko / Florence T Bourgeois

PLoS Neglected Tropical Diseases, Vol 13, Iss 1, p e

An assessment of gaps in research prioritization.

2019 Volume 0007111

Abstract: BACKGROUND:Despite the known burden of neglected tropical diseases (NTDs) on child health, there is limited information on current efforts to increase pediatric therapeutic options. Our objective was to quantify and characterize research activity and ... ...

Abstract	BACKGROUND:Despite the known burden of neglected tropical diseases (NTDs) on child health, there is limited information on current efforts to increase pediatric therapeutic options. Our objective was to quantify and characterize research activity and treatment availability for NTDs in children in order to inform the prioritization of future research efforts. METHODOLOGY/PRINCIPAL FINDINGS:We conducted a review of the World Health Organization's (WHO) International Clinical Trials Registry Platform to assess research activity for NTDs. The burden of disease of each NTD was measured in terms of disability adjusted life years (DALYs), which was extracted from the Global Health Data Exchange. First- and second-line medications for each NTD were identified from WHO guidelines. We reviewed FDA drug labels for each medication to determine whether they were adequately labeled for use in children. Descriptive statistics, binomial tests, and Spearman's rank order correlations were calculated to assess research activity compared to burden of disease. Children comprised 34% of the 20 million DALYs resulting from NTDs, but pediatric trials contributed just 17% (63/369) of trials studying these conditions (p<0.001 for binomial test). Conditions that were particularly under-represented in pediatric populations compared to adults included rabies, leishmaniasis, scabies, and dengue. Pediatric drug trial activity was poorly correlated with pediatric burden of disease across NTDs (Spearman's rho = 0.41, p = 0.12). There were 47 medications recommended by the WHO for the treatment of NTDs, of which only 47% (n = 22) were adequately labeled for use in children. Of the 25 medications lacking adequate pediatric labeling, three were under study in pediatric trials. CONCLUSIONS/SIGNIFICANCE:There is a substantial gap between the burden of disease for NTDs in children and research devoted to this population. Most medications lack adequate pediatric prescribing information, highlighting the urgency to increase pediatric research ...
Keywords	Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Comparative effectiveness research

Florence T Bourgeois / Srinivas Murthy / Kenneth D Mandl

PLoS ONE, Vol 7, Iss 1, p e

an empirical study of trials registered in ClinicalTrials.gov.

2012 Volume 28820

Abstract: The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) ... ...

Abstract	The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program.We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results.231 (22.3%; 95% CI 19.8%-24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%-80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%-39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%-44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001).In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.
Keywords	Medicine ; R ; Science ; Q
Subject code	380
Language	English
Publishing date	2012-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Premarket safety and efficacy studies for ADHD medications in children.

Florence T Bourgeois / Jeong Min Kim / Kenneth D Mandl

PLoS ONE, Vol 9, Iss 7, p e

2014 Volume 102249

Abstract: Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ... ...

Abstract	Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.
Keywords	Medicine ; R ; Science ; Q
Subject code	150
Language	English
Publishing date	2014-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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