Is COVID the gamechanger for decentralized trials?

The shortcomings of the current model for clinical research are well documented. It costs around $26,000 to enroll the average trial participant, of whom one in three typically drops out during the study. This leads to significant delays as only one in seven trials succeeds in enrolling patients in sufficient numbers.    More worryingly, 18% fail to attract a single patient.  The consequences are dire, not just in terms of the $40bn that the pharma industry wastes merely on ‘time costs’ every year. Many patients never learn of clinical research as a viable treatment option, and if they do, their participation remains fraught with obstacles.  “Structural and clinical barriers are the reasons more than three out of four patients do not participate in trials” says Dr. Joseph Unger, a health services researcher at the Hutchinson Cancer Research Center, and author of a recent systematic review published in the Journal of the National Can cer Institute.   Since 70% of US target patients live more than two hours from the closest authorized research site, many industry stakeholders have come to believe that changes such as remote participation and research de-centralization are the only viable answers to fixing the current system. COVID 19 as an inflection point   More than a decade since the first decentralized clinical trial was run, progress in scaling remote data collection and distributing clinical research ...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news

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Source: International Journal of General Medicine - Category: General Medicine Tags: International Journal of General Medicine Source Type: research
Curr Issues Mol Biol. 2021 Sep 22;43(3):1212-1225. doi: 10.3390/cimb43030086.ABSTRACTThe coronavirus SARS-CoV-2 is the cause of the ongoing COVID-19 pandemic. Most SARS-CoV-2 infections are mild or even asymptomatic. However, a small fraction of infected individuals develops severe, life-threatening disease, which is caused by an uncontrolled immune response resulting in hyperinflammation. However, the factors predisposing individuals to severe disease remain poorly understood. Here, we show that levels of CD47, which is known to mediate immune escape in cancer and virus-infected cells, are elevated in SARS-CoV-2-infected ...
Source: Current Issues in Molecular Biology - Category: Molecular Biology Authors: Source Type: research
Am J Psychother. 2021 Oct 26:appipsychotherapy20210030. doi: 10.1176/appi.psychotherapy.20210030. Online ahead of print.NO ABSTRACTPMID:34696597 | DOI:10.1176/appi.psychotherapy.20210030
Source: American Journal of Psychotherapy - Category: Psychiatry & Psychology Authors: Source Type: research
A few weeks ago, we kickstarted a new series of articles contemplating the moves of pharmaceutical heavyweights in the digital health arena. The first batch of companies, Johnson &Johnson, Pfizer, Bayer and Novartis, seem to have some interest in remote healthcare solutions and DTx.  In this second article, we will explore which trends pharma giants Merck, GlaxoSmithKline, AbbVie, Sanofi and Bristol Myers Squibb are eyeing. Merck: big tech-friendly A big pharma company itself, Germany’s Merck hasn’t shied from teaming up with big tech companies in recent years as it aims to make a lasting ...
Source: The Medical Futurist - Category: Information Technology Authors: Tags: Artificial Intelligence in Medicine Biotechnology Future of Medicine Future of Pharma Health Sensors & Trackers Personalized Medicine Portable Medical Diagnostics Security & Privacy pharmaceutics 23andme philips big pharma Merck Source Type: blogs
A recently amended California law will now allow the estates of deceased plaintiffs, including mesothelioma patients, to collect pain and suffering damages. Previously, only the person who sustained bodily injury could recover pain and suffering damages. These damages are often the largest sums of money at stake in many mesothelioma lawsuits. When it becomes law on Jan. 1, Senate Bill 447 will expand the range of recoverable damages and eliminate long-standing restrictions. The amended statute, signed Oct. 1, allows California to join 45 other states that permit the recovery of noneconomic damages for an assort...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Source Type: news
Mayo Clin Proc Innov Qual Outcomes. 2021 Oct 18. doi: 10.1016/j.mayocpiqo.2021.10.003. Online ahead of print.ABSTRACTOBJECTIVE: To assess the impact of measures designed to mitigate the spread of COVID-19 on worldwide cancer screening.PATIENT AND METHODS: We systematically searched PubMed.gov, Ovid Medline, the Cochrane COVID-19 study register, ClinicalTrials.gov, and Embase without language restrictions for studies published between January 1, 2021 and February 10, 2021. Studies were selected for full text review which contained data on patients screened for any type of cancer during the COVID-19 pandemic and comparison d...
Source: Clinical Breast Cancer - Category: Cancer & Oncology Authors: Source Type: research
Am Surg. 2021 Oct 23:31348211051699. doi: 10.1177/00031348211051699. Online ahead of print.ABSTRACTBACKGROUND: Initial reports of significantly worse outcomes for cancer patients with COVID-19 led to guidelines for triaging surgical cancer treatment. We sought to evaluate the effects of the COVID-19 pandemic on oncologic surgical specialty referrals.METHODS: We compared referrals to oncologic surgical specialty clinics at an academic tertiary care institution following implementation of stay-at-home orders in California (3/19/20-7/31/20, "COVID") to the same time period the year prior (3/19/19-7/31/19, "Pre-...
Source: The American Surgeon - Category: Surgery Authors: Source Type: research
Mayo Clin Proc Innov Qual Outcomes. 2021 Oct 18. doi: 10.1016/j.mayocpiqo.2021.10.003. Online ahead of print.ABSTRACTOBJECTIVE: To assess the impact of measures designed to mitigate the spread of COVID-19 on worldwide cancer screening.PATIENT AND METHODS: We systematically searched PubMed.gov, Ovid Medline, the Cochrane COVID-19 study register, ClinicalTrials.gov, and Embase without language restrictions for studies published between January 1, 2021 and February 10, 2021. Studies were selected for full text review which contained data on patients screened for any type of cancer during the COVID-19 pandemic and comparison d...
Source: Clinical Genitourinary Cancer - Category: Cancer & Oncology Authors: Source Type: research
The most commonly used molecular diagnostic technique is the polymerase chain reaction (PCR). PCR detects a short section of genetic code of interest, a cancer gene, human mRNA or a pathogen's genome. It is used by every specialty in medicine and surgery, with increasing frequency and importance. In this article, the history, steps of the cycle, uses, forms, advantages and disadvantages of PCR are discussed. With the SARS coronavirus-2 pandemic having such an enormous impact on the delivery of elective surgery, decisions to proceed or defer are made by surgeons on a daily basis, based on PCR results.
Source: Surgery (Medicine Publishing) - Category: Surgery Authors: Tags: Infection Source Type: research
This article summarises the full statement, which is available at https://www.canceraustralia.gov.au/covid-19/covid-19-recovery-implications-cancer-care.MAIN RECOMMENDATIONS: The statement is informed by a desktop literature review and input from cancer experts and consumers at a virtual roundtable, held in July 2020, on key elements of cancer care that changed during the pandemic. It describes targeted strategies (at system, service, practitioner and patient levels) to retain, enhance and embed high value changes in practice. Principal strategies include: implementing innovative models of care that are digitally enabled a...
Source: Medical Journal of Australia - Category: General Medicine Authors: Source Type: research
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