An update on the validation of whole slide imaging systems following FDA approval of a system for a routine pathology diagnostic service in the United States

2017 ◽  
Vol 92 (6) ◽  
pp. 381-389 ◽  
Author(s):  
BF Boyce
Keyword(s):  
United States ◽  
The United States ◽  
Imaging Systems ◽  
Whole Slide Imaging ◽  
Diagnostic Service ◽  
Fda Approval

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

scholarly journals National Trends in Hospitalizations for Sickle Cell Disease in the United States Following the FDA Approval of Hydroxyurea, 1998–2008

Medical Care ◽  
2014 ◽  
Vol 52 (7) ◽  
pp. 612-618 ◽  
Author(s):  
Maureen M. Okam ◽  
Shimon Shaykevich ◽  
Benjamin L. Ebert ◽  
Alan M. Zaslavsky ◽  
John Z. Ayanian
Keyword(s):  
United States ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
The United States ◽  
Cell Disease ◽  
Fda Approval ◽  
National Trends

scholarly journals Positive Women: Emotion, Memory, and the Power of Narrative in Women Organized to Respond to Life-Threatening Diseases, 1991-2020

2020 ◽  
pp. 46-93
Author(s):  
Eleanor Naiman
Keyword(s):  
United States ◽  
The United States ◽  
People Of Color ◽  
Hiv Diagnosis ◽  
Aids Epidemic ◽  
Fda Approval ◽  
Published Report ◽  
Life Threatening ◽  
Emotion Memory ◽  
Personal Fulfillment

Note: In lieu of an abstract, this is the article's first paragraph. "By 1992, the AIDS epidemic in the United States had reached seemingly catastrophic proportions. Over ten years after the first published report of AIDS-related lung infection, the number of AIDS cases in the United States far exceeded 100,000. It would be four years until the FDA approval of the first protease inhibitor. Over ten thousand women had been diagnosed with the disease, and experts expected over ninety thousand more were already infected. The disease, lacking effective treatment, increasingly struck women and people of color in the early 1990s; cases rose 151 percent among women and by 105 percent among men in 1993. Without a cure in sight, women with HIV did not have much tangible reason for optimism. Nonetheless, in January 1992 Debra McCarthy cast her HIV diagnosis as the turning point in her journey towards personal fulfillment. “Even though I may be HIV positive,” she wrote, “I am more healed in my life than I ever have been.”"

scholarly journals US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

2018 ◽  
Vol 142 (11) ◽  
pp. 1383-1387 ◽  
Author(s):  
Andrew J. Evans ◽  
Thomas W. Bauer ◽  
Marilyn M. Bui ◽  
Toby C. Cornish ◽  
Helena Duncan ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Digital Pathology ◽  
The United States ◽  
Primary Diagnosis ◽  
Clinical Applications ◽  
Whole Slide Imaging ◽  
The Us ◽  
Available Information

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions

1969 ◽  
Vol 17 (3) ◽  
Author(s):  
Iraj Daizadeh
Keyword(s):  
United States ◽  
Drug Development ◽  
Drug Application ◽  
The United States ◽  
Data Repository ◽  
Fda Approval ◽  
New Drug Application ◽  
Development Paradigm ◽  
Prescribing Information ◽  
Insight Into

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed – a USPI data repository – reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.

scholarly journals POST FDA APPROVAL EXPERIENCE OF LEFT ATRIAL APPENDAGE OCCLUSION IN THE UNITED STATES

2016 ◽  
Vol 67 (13) ◽  
pp. 665
Author(s):  
David R. Holmes ◽  
Vivek Reddy ◽  
Saibal Kar ◽  
Douglas Gibson ◽  
Shephal Doshi ◽  
...  
Keyword(s):  
United States ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
The United States ◽  
Atrial Appendage ◽  
Left Atrial Appendage Occlusion ◽  
Fda Approval

scholarly journals Cancer Disparities and Black American Representation in Clinical Trials Leading to the Approval of Oral Chemotherapy Drugs in the United States Between 2009 and 2019

2021 ◽  
Vol 17 (5) ◽  
pp. e623-e628 ◽  
Author(s):  
Veronica B. Ajewole ◽  
Oyinkansola Akindele ◽  
Uzoamaka Abajue ◽  
Okwuoma Ndulue ◽  
Jazzmin J. Marshall ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
Oral Chemotherapy ◽  
Chemotherapy Drugs ◽  
Fda Approval ◽  
Incidence And Mortality ◽  
Cancer Types ◽  
Clinical Trials Registry ◽  
Chemotherapy Agents

PURPOSE: Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)–approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA’s representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate). METHODS: A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA’s Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry. RESULTS: Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population. CONCLUSION: BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.

Medicines that Work for Fibromyalgia

2002 ◽  
Author(s):  
Daniel J. Wallace ◽  
Janice Brock Wallace
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Control ◽  
Insurance Companies ◽  
Controlled Trials ◽  
Fda Approval ◽  
Or Groups ◽  
Natural Remedies ◽  
Antianxiety Drug ◽  
Double Blinded

Nobody likes to take medicine. Many fibromyalgia patients, in particular, prefer to treat their condition with natural remedies, and many are reluctant to take prescribed medication. This problem is made more difficult because many of the most helpful preparations are designated as antidepressants. Some patients become concerned that this might create a stigma. “If you really believe what I am saying, and are convinced that I am not crazy, why are you giving me an antidepressant or antianxiety drug?” is a question we frequently hear. This problem is compounded when some insurance companies refuse to reimburse patients for these preparations, claiming that they are uncovered “psychiatric benefits.” Management of fibromyalgia includes medications from separate families or groups, in which at least one agent has been shown in double-blinded, controlled trials (where some of the study subjects get placebo, or sugar pills) to be effective in fibromyalgia patients. The rationale for using these drugs in treating fibromyalgia is reviewed in this chapter, but first the scientific logic behind putting these drugs on our “A” list will be discussed. In the United States, the Food and Drug Administration (FDA) approves drugs for specific indications. It takes many years and many dollars for an agent to be approved for a specific use, and since fibromyalgia was not recognized as a disorder until 1990, no drugs currently have FDA approval for the condition. Many of the remedies purported to help fibromyalgia are beyond the FDA’s regulatory control. These include a variety of vitamins and agents that are licensed as food supplements. As a result, promising preparations such as DHEA and melatonin (reviewed in chapter 22) are widely available without a prescription and are being taken by patients even though few controlled trials have documented their safety or efficacy. For example, there is no legal obligation to prove that a 3-mg tablet of melatonin really contains 3 mg. Also, each batch of medication can be mixed with varying preservatives, which may affect its delivery, or bioavailability. Some of our patients have no difficulty taking the medication but react to its packaging. Physicians who manage fibromyalgia patients must rely on scientific studies showing that a drug is effective in alleviating a particular condition.

scholarly journals Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke

Neurosurgery ◽  
2013 ◽  
Vol 73 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Maxim Mokin ◽  
Travis M. Dumont ◽  
Erol Veznedaroglu ◽  
Mandy J. Binning ◽  
Kenneth M. Liebman ◽  
...  
Keyword(s):  
United States ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Strong Predictor ◽  
Intravenous Thrombolysis ◽  
The United States ◽  
Nihss Score ◽  
Fda Approval ◽  
Flow Restoration ◽  
Solitaire Fr

Abstract BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led to Food and Drug Administration (FDA) approval of the Solitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS: We conducted a retrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS: A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ⩽2). Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION: Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States. Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

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