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  • 1
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-12-01, Vol.28 (12), p.3-3
    Description: If you were tired of hearing that it costs, on average, $2.6 billion to develop one drug through clinical trials to approval for marketing, then here is your new best statistic from our friends at Tufts Center for the Study of Drug Development (Tufts CSDD). Tufts CSDD and The Avoca Group recently released the results of its Benchmarks for the Vendor Qualification Process (see https://bit.ly/2LkYjM3) and Ken Getz, professor and deputy director of Tufts CSDD, shared at the Clinical Trials Europe event in Barcelona last month that $375 million is how much sponsors spend yearly on the request for information (RFI), new vendor qualification, and vendor requalification process for outsourced activities. $375 million. According to Getz, the functional silos of pharma, as well as their fragmentation, contributes to vendor qualification complexity.
    Subject(s): Clinical trials ; Computer organization ; Drug approval ; Economic aspects ; Outsourcing
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 2
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-10-01, Vol.28 (10), p.2-2
    Description: The Avoca Group has published the results of its 2018 Industry Report "Clinical Outsourcing Spend and Key Relationships Measures." In that section, Salotti suggests that individual respondents' industry tenure and exposure may be becoming more apparent in these results, specific to the key outsourcing health indicators-relationship, quality, delivery, and value. The usual caveat, while we focus on the issues and topics on our website throughout the year, the next time we revisit the clinical operations and outsourcing relationships piece in focused issues is next year.
    Subject(s): Forecasts and trends ; Millennials ; Outsourcing ; Polls & surveys ; Reports ; Surveys
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 3
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-09-01, Vol.28 (9), p.3-3
    Description: The 'traditional, dedicated research site" is morphing to model more efficient, professional, and technologically robust practices and processes that rival those of CROs, while specialty physician groups and large IDNs integrate professional providers that operationalize clinical research within their unique clinical care workflows. [...]at the Veteran's Administration, executives are attacking their own bureaucracies to unify study start-up and make VA clinics a competitive option for sponsored research. ACRP also rolled out its ACRP Core Competency Framework two years ago, initiated so industry could begin to level set the various roles at sites and is discussed as a tool used by many in our main feature (see page 24). Given the dire straits of patient enrollment, as well as the diverse ways to reach potential participants, it makes sense to take recruitment out of the core site responsibility, and make it a more strategic process.
    Subject(s): Analysis ; Clinical trials ; Medical research ; Medicine, Experimental ; Professionals ; Trends
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 4
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-07-01, Vol.28 (7-8), p.2-2
    Subject(s): Clinical trials
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 5
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-06-01, Vol.28 (6), p.3-3
    Subject(s): Breast cancer ; Clinical trials ; FDA approval ; Fulvestrant ; Metastasis ; Oncology
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 6
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-05-01, Vol.28 (5), p.2-2
    Description: According to Sillup, there are 1.3 million nursing home residents, and up to half have some kind of cognitive impairment. [...]according to Cherian Verghese, MD, a neurologist and medical director and principal investigator of Keystone Clinical Studies, clinical trial enrollment is difficult because of a lack of awareness, as well as the separation between healthcare and clinical trials, which does not foster collaboration of care. For those that work for or with nursing care facilities, the lack of pharmaceutical interventions for Alzheimer's means a greater reliance on non-traditional medicines, or physical and mental exercise.
    Subject(s): Alzheimer's disease ; Alzheimers disease ; Biomarkers ; Clinical trials ; Dementia ; Nursing care ; Nursing homes ; Pharmaceuticals ; Powers of attorney
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 7
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-04-01, Vol.28 (4), p.2-2
    Description: The transition of the contract research industry from a small cottage to a fully-matured one has seen numerous outsourcing models from the low-touch, very focused and accountable transactional service, to the high-touch, highly involved and complex strategic partnership. Why should CROs be concerned about their service offerings for these emerging players? Because they are not an insignificant part of the drug development landscape. Consider the following: * Of all companies sponsoring one or more clinical development programs, 61% now fall outside the ranks of the top 50 largest pharma. * The percentage of FDA approvals obtained by big pharma in 2018 was 26%, compared to 60% that went to firms that had never before received an approval.
    Subject(s): Biological products industry ; Clinical trials ; Initial public offerings
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 8
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-03-01, Vol.28 (3), p.3-3
    Description: Barriers to getting people more involved are numerous: lack of awareness, lack of health literacy and education, mistrust or desire, physician awareness or aptitude, lack of a cohesive healthcare to research pathway, lack of patient involvement in trial design, ability to find a trial, ability to adhere and stay motivated in a trial... all of these factors and more go into the overall challenge of patient centric initiatives. [...]patient education and awareness is another key piece missing in clinical research. At the end of the article, the authors note, "The objectives of awareness and clinical research literacy are no longer to primarily increase patient recruitment rates.
    Subject(s): Advocacy ; Analysis ; Clinical trials ; Medical care ; Medical research ; Medicine, Experimental ; Patients ; Research & development--R&D
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 9
    Article
    Article
    2019
    ISSN: 1064-8542 
    Language: English
    In: Applied clinical trials, 2019-01-01, Vol.28 (1-2), p.2-2
    Subject(s): Clinical trials ; Compensation ; Incentive plans ; Merit increases ; Trends
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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  • 10
    Language: English
    In: Applied clinical trials, 2018-12-01, Vol.27 (12), p.3-3
    Description: CDER and the FDA have backed up their support of basket trials, master protocols, and more collaborative types of trials by initiating for comment on Oct. 1 the draft guidance, "Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics." FDA also put forth for comment its draft guidance, intending to replace one from 2010, "Adaptive Designs for Clinical Trials of Drugs and Biologics," which provides direction on "the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial." In another article from Bloomberg Law, bit.ly/2FU5lZf, FDA Commissioner Scott Gottlieb hinted that CROs may need to reflect on their own processes that may be unnecessarily bloating drug development costs without adding value.
    Subject(s): Clinical trials ; Design ; Economic aspects ; Gottlieb, Scott ; Laws, regulations and rules ; Political aspects
    ISSN: 1064-8542
    E-ISSN: 2150-623X
    Source: Academic Search Ultimate
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