Publications by authors named "Harry P Selker"

Article Synopsis
  • The study analyzed data from 7 trials with 1,774 STEMI patients to understand how the location of the infarct artery affects heart injury and outcomes after primary coronary intervention.
  • Results showed that patients with anterior STEMI (affecting the left anterior descending artery) had a larger median infarct size and were at a higher risk for mortality and heart failure hospitalization compared to those with nonanterior STEMI.
  • The research concluded that anterior STEMI leads to more severe heart damage and worse overall prognosis, highlighting the importance of infarct location in patient outcomes.
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Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations.

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Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.

Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes.

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Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.

Methods: These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.

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New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date.

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Objectives: We developed a questionnaire-based risk-scoring system to identify children at risk for rheumatic heart disease (RHD) in rural India. The resulting predictive model was validated in Nepal, in a population with a similar demographic profile to rural India.

Methods: The study involved 8646 students (mean age 13.

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One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities.

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Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens.

Methods: A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery.

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Article Synopsis
  • A recent study found that about 50% of patients experiencing their first ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs) had excess early mortality compared to those with SMuRFs.
  • Researchers analyzed data from 10 clinical trials, comparing 2,862 STEMI patients, with 524 of them identified as SMuRF-less.
  • Results indicated that SMuRF-less patients were more likely to have poor blood flow before intervention, but there were no significant differences in infarct size, heart function, or 30-day and 1-year mortality rates between the two groups.
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Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses.

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Importance: Oral anthelmintic niclosamide has potent in vitro antiviral activity against SARS-CoV-2. Repurposed niclosamide could be a safe and efficacious COVID-19 therapy.

Objective: To investigate whether niclosamide decreased SARS-CoV-2 shedding and duration of symptoms among patients with mild to moderate COVID-19.

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Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient.

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Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.

Methods: The TIN's three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic's rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19.

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Introduction: The Clinical and Translational Science Awards (CTSA) Consortium, a network of academic health care institutions with CTSA hubs, is charged with improving the national clinical and translational research enterprise. The CTSA Consortium and the NIH National Center for Advancing Translational Sciences implemented the Common Metrics Initiative comprised of standardized metrics and a shared performance improvement framework. This article summarizes hubs' perspectives on its value during the initial implementation.

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The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results of efforts to increase subject accrual into a set of clinical trials within the expected time period. A pilot test of the MAR was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs.

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Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeopardizes answering research questions meaningfully, and delays translating research discoveries into improved health. This paper reports the results of a pilot test of the Median Accrual Ratio (MAR) metric developed as a part of the Common Metrics Initiative of the NIH's National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award (CTSA) Consortium. Using the metric is intended to enhance the ability of the CTSA Consortium and its "hubs" to increase subject accrual into trials within expected timeframes.

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Introduction: The Clinical and Translational Science Awards (CTSA) Consortium, about 60 National Institutes of Health (NIH)-supported CTSA hubs at academic health care institutions nationwide, is charged with improving the clinical and translational research enterprise. Together with the NIH National Center for Advancing Translational Sciences (NCATS), the Consortium implemented Common Metrics and a shared performance improvement framework.

Methods: Initial implementation across hubs was assessed using quantitative and qualitative methods over a 19-month period.

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Background: Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI.

Methods: Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled.

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Objectives: We examined the level of awareness about Rheumatic Heart Disease (RHD) among school-aged children in a rural district of India and evaluated the effects of a questionnaire-based survey in improving the level of awareness.

Methods: The study involved 8,646 students aged 10-16 years from 20 schools in West Midnapore, India which was conducted in August 2017. We examined changes in the level of awareness of RHD using a 29-point scoring system in seven domains.

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Introduction: Shared patient-clinician decision-making is central to choosing between medical treatments. Decision support tools can have an important role to play in these decisions. We developed a decision support tool for deciding between nonsurgical treatment and surgical total knee replacement for patients with severe knee osteoarthritis.

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Introduction: Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).

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Background: Smoking is a well-established risk factor for ST-segment elevation myocardial infarction (STEMI); however, once STEMI occurs, smoking has been associated with favorable short-term outcomes, an observation termed the "smoker's paradox." It has been postulated that smoking might exert protective effects that could reduce infarct size, a strong independent predictor of worse outcomes after STEMI.

Objectives: The purpose of this study was to determine the relationship among smoking, infarct size, microvascular obstruction (MVO), and adverse outcomes after STEMI.

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