2020
DOI: 10.3389/fonc.2020.01604
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Early Access Provision for Innovative Medicinal Products in Oncology: Challenges and Opportunities

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Cited by 5 publications
(6 citation statements)
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“…Delay in access becomes an ethical dilemma in clinical areas for which therapeutic needs are huge [ 9 , 10 ] and for people with serious, debilitating or life-threatening diseases without available treatment options due to comorbidities, exhaustion of all treatment options, adverse events, among others [ 10 , 11 ]. Lack of patient early access to promising innovation may represent huge individual opportunity costs when available information suggests that accessing a treatment earlier in the progression of a patient’s pathology may avoid health deterioration, which will otherwise occur due to long waiting times until official market authorisation.…”
Section: Introductionmentioning
confidence: 99%
“…Delay in access becomes an ethical dilemma in clinical areas for which therapeutic needs are huge [ 9 , 10 ] and for people with serious, debilitating or life-threatening diseases without available treatment options due to comorbidities, exhaustion of all treatment options, adverse events, among others [ 10 , 11 ]. Lack of patient early access to promising innovation may represent huge individual opportunity costs when available information suggests that accessing a treatment earlier in the progression of a patient’s pathology may avoid health deterioration, which will otherwise occur due to long waiting times until official market authorisation.…”
Section: Introductionmentioning
confidence: 99%
“…Potential barriers include financial and operational burdens for the manufacturer (high drug costs and limited supplies, requirement for certified expert treatment centers, need for close and extensive patient monitoring and follow-up, administrative efforts). Manufacturers may also worry that poor patient outcomes or adverse events arising during expanded access treatment may jeopardize any subsequent new drug application ( 6 ). In reality, the latter fear appears unfounded.…”
Section: Discussionmentioning
confidence: 99%
“…Rare cancers are estimated to account for around 20-24% of all cancers diagnosed, albeit with disparities in both incidence and survival between different countries ( 2 4 ). However, clinical trials of innovative medicinal products (InMPs) in oncology and particularly for rare cancers are subject to a number of inherent challenges ( 5 , 6 ). Foremost, the patient population available is generally made up of those who have not responded to all existing standard therapies, for who there remain very limited treatment options, and who may have a short life expectancy.…”
Section: Introductionmentioning
confidence: 99%
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