ArticleJournal of managed care & specialty pharmacy2018
The Potential Effect of the 21st Century Cures Act on Drug Development.
Article in Journal of managed care & specialty pharmacy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Transforming stroke care: the promise of feedback-guided thrombolytic nanomedicine.Journal of nanobiotechnology · 2026Review
- Article
- A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach.Journal of clinical and translational science · 2024Article
- Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
- Regulations, Open Data and Healthcare Innovation: A Case of MSK-IMPACT and Its Implications for Better Cancer Care.Cancers · 2021Article
- Patient generated health data and electronic health record integration in oncologic surgery: A call for artificial intelligence and machine learning.Journal of surgical oncology · 2021Review
- Comparing Randomized Controlled Trials and Real-World Studies in Chronic Obstructive Pulmonary Disease Pharmacotherapy.International journal of chronic obstructive pulmonary disease · 2020Review
- SMART Markers: collecting patient-generated health data as a standardized property of health information technology.NPJ digital medicine · 2020Article
- Ethics codes and use of new and innovative drugs.British journal of clinical pharmacology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Enacted in December 2016, the 21st Century Cures Act is a pivotal piece of legislation that will influence the FDA drug and device approval process for the foreseeable future. Although this legislation received overwhelming support by members of Congress for much needed budgetary increases for the FDA and other national health organizations, there is much controversy over certain provisions that potentially diminish the robustness of the evidence base required for drug and medical device approvals. This article discusses the key provisions from "Title III - Development" under "Division A - 21st Century Cures" related to drug development and, specifically, explores those aspects that address patient-focused drug development, use of surrogate endpoints in clinical trials, modernization of trial design, and use of real-world evidence for decision making and health care economic information. In addition, specific legislation on regulatory changes is discussed pertaining to antimicrobial stewardship. Essentially, summarized interpretations are presented here of the provisions covering the aforementioned topics, along with insights into potential intended and unintended consequences for U.S. health care payers, health care providers, government entities, and product manufacturers. DISCLOSURES: No outside funding supported this writing. Goble is completing fellowship training sponsored by Novartis Pharmaceuticals.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.