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7 results

  • The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium

  • Elaine H. Morrato, Lindsay A. Lennox, James W. Dearing, Anne T. Coughlan, Elaina S. Gano, Doug McFadden, Nallely Mora, Harold Alan Pincus, Gary S. Firestein, Robert Toto, Steven E. Reis
  • Journal:
    Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
    Published online by Cambridge University Press:
    29 September 2023, e224
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  • The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become “Evolve to Next-Gen ACT” (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT’s development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation’s RWD/RWE research capacity.

  • 10 - A “DESI” for Devices?

  • from Part III - Designing Medical Device Regulations
  • Edited by I. Glenn Cohen, Harvard Law School, Massachusetts, Timo Minssen, University of Copenhagen, W. Nicholson Price II, University of Michigan, Ann Arbor, Christopher Robertson, Boston University, Carmel Shachar, Harvard Law School, Massachusetts
  • Book:
    The Future of Medical Device Regulation
    Published online:
    31 March 2022
    Print publication:
    07 April 2022, pp 129-140
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  • Summary

    The FDA has put guidance in place detailing how it will use RWE while regulating medical devices and published a framework to explain its use of RWE in regulating drugs. Inside the agency, influential officials resist the use of RWE in regulatory decision-making while championing the importance of randomized controlled trials. Outside, a growing body of literature highlights the challenges involved in securing high-quality evidence postapproval. Growing safety concerns about several medical devices — discovered only after real world use — has renewed calls for more rigorous pre and postmarket evaluation

  • A Market Review of Available Airway Suction Technology

  • Sarah A. Johnson, Ryann S. Lauby, R. Lyle Hood, Robert A. De Lorenzo, Steven G. Schauer
  • Journal:
    Prehospital and Disaster Medicine / Volume 37 / Issue 3 / June 2022
    Published online by Cambridge University Press:
    31 March 2022, pp. 390-396
    Print publication:
    June 2022
  • Introduction:

    Airway injuries are the second leading cause of potentially survivable battlefield death and often require airway management strategies. Airway suction, the act of using negative pressure in a patient’s upper airway, removes debris that can prevent respiration, decreases possible aspiration risks, and allows clearer viewing of the airway for intubation. The most important characteristics for a portable airway suction device for prehospital combat care are portability, strong suction, and ease of use.

    Methods:

    This market review searched academic papers, military publications, Google searches, and Amazon to identify devices. The search included specific characteristics that would increase the likelihood that the devices would be suitable for battlefield use including weight, size, battery life, noise emission, canister size, tubing, and suction power.

    Results:

    Sixty portable airway suction devices were resulted, 31 of which met inclusion criteria – 11 manually powered devices and 20 battery-operated devices. One type of manual suction pump was a bag-like design with a squeezable suction pump that was extremely lightweight but had limited suction capabilities (vacuum pressure of 100mmHg). Another type of manual suction pump had a trigger-like design which is pulled back to create suction with a firm collection canister that had increased suction capabilities (vacuum pressures of 188-600mmHg), though still less than the battery operated, and was slightly heavier (0.23-0.458kg). Battery-operated devices had increased suction capabilities and were easier to use, but they were larger and weighed more (1.18-11.0kg).

    Conclusion:

    Future research should work to lighten and debulk battery-operated suction devices with high suction performance.

  • 26 - Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development

  • from Section 3 - Alzheimer’s Disease Clinical Trials
  • Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
  • Book:
    Alzheimer's Disease Drug Development
    Published online:
    03 March 2022
    Print publication:
    31 March 2022, pp 301-308

  • Summary

    Expanded access and compassionate use refer to the use of an investigational new drug outside of a clinical trial to treat a patient with a serious or life-threatening disease who are not eligible or it is not feasible to participate in randomized, clinical trials. The Food and Drug Administration oversees the expanded-access program and provides guidance for the stakeholders. The expanded-access process provides a potential mechanism to facilitate Alzheimer’s disease (AD) drug development process and increase access to investigational new drugs for patients with AD.

  • Dietary supplements in the USA: problematic trends

  • Bryan E Denham
  • Journal:
    Public Health Nutrition / Volume 24 / Issue 9 / June 2021
    Published online by Cambridge University Press:
    26 February 2021, pp. 2771-2775
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  • More than 25 years have passed since the Dietary Supplement Health and Education Act of 1994 classified dietary supplements as a subcategory of food, thereby exempting manufacturers from providing premarket evidence of product safety and efficacy. In this commentary, I discuss problems in the supplement industry through an examination of cases introduced or decided in US federal courts between 2010 and 2019. More than half the cases located involved defendants charged with introducing misbranded food or drugs into interstate commerce. Contaminants included anabolic steroids, erectile dysfunction medications, weight-loss drugs, workout stimulants and mind-altering substances. As the article points out, raw powders obtained in bulk quantities facilitate the practice of ‘home brewing’ and the introduction of prescription drugs into dietary supplements.

  • The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?

  • Joan E. Adamo, Robert V. Bienvenu II, F. Owen Fields, Soma Ghosh, Christina M. Jones, Michael Liebman, Mark S. Lowenthal, Scott J. Steele
  • Journal:
    Journal of Clinical and Translational Science / Volume 2 / Issue 5 / October 2018
    Published online by Cambridge University Press:
    06 December 2018, pp. 295-300
    • Article
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  • Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.

  • Assessment of Groin Application of Junctional Tourniquets in a Manikin Model

  • John F. Kragh, Jr., Matthew P. Lunati, Chetan U. Kharod, Cord W. Cunningham, Jeffrey A. Bailey, Zsolt T. Stockinger, Andrew P. Cap, Jacob Chen, James K. Aden, 3d, Leopoldo C. Cancio
  • Journal:
    Prehospital and Disaster Medicine / Volume 31 / Issue 4 / August 2016
    Published online by Cambridge University Press:
    27 May 2016, pp. 358-363
    Print publication:
    August 2016
  • Introduction

    To aid in preparation of military medic trainers for a possible new curriculum in teaching junctional tourniquet use, the investigators studied the time to control hemorrhage and blood volume lost in order to provide evidence for ease of use.

    Hypothesis

    Models of junctional tourniquet could perform differentially by blood loss, time to hemostasis, and user preference.

    Methods

    In a laboratory experiment, 30 users controlled simulated hemorrhage from a manikin (Combat Ready Clamp [CRoC] Trainer) with three iterations each of three junctional tourniquets. There were 270 tests which included hemorrhage control (yes/no), time to hemostasis, and blood volume lost. Users also subjectively ranked tourniquet performance. Models included CRoC, Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT). Time to hemostasis and total blood loss were log-transformed and analyzed using a mixed model analysis of variance (ANOVA) with the users represented as random effects and the tourniquet model used as the treatment effect. Preference scores were analyzed with ANOVA, and Tukey’s honest significant difference test was used for all post-hoc pairwise comparisons.

    Results

    All tourniquet uses were 100% effective for hemorrhage control. For blood loss, CRoC and SJT performed best with least blood loss and were significantly better than JETT; in pairwise comparison, CRoC-JETT (P < .0001) and SJT-JETT (P = .0085) were statistically significant in their mean difference, while CRoC-SJT (P = .35) was not. For time to hemostasis in pairwise comparison, the CRoC had a significantly shorter time compared to JETT and SJT (P < .0001, both comparisons); SJT-JETT was also significant (P = .0087). In responding to the directive, “Rank the performance of the models from best to worst,” users did not prefer junctional tourniquet models differently (P > .5, all models).

    Conclusion

    The CRoC and SJT performed best in having least blood loss, CRoC performed best in having least time to hemostasis, and users did not differ in preference of model. Models of junctional tourniquet performed differentially by blood loss and time to hemostasis.

    KraghJFJr , LunatiMP , KharodCU , CunninghamCW , BaileyJA , StockingerZT , CapAP , ChenJ , AdenJK3d , CancioLC . Assessment of Groin Application of Junctional Tourniquets in a Manikin Model. Prehosp Disaster Med. 2016;31(4):358–363.