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Rare Diseases Drug Development
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Shein-Chung Chow, Shutian Zhang, Wei Zhang
Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need. Serious condition is referred to as the determination of the seriousness of a disease. The determination is a matter of judgment, but generally is based on whether the drug will affect the factors such as survival, day-to-day functioning, or the likelihood that the disease (if left untreated) will progress from a less severe condition to a more serious one. For a drug to address an unmet medical need, the drug must be developed as a treatment or preventative measure for a disease that exists no current therapy. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment. For example, (i) showing superior effectiveness, (ii) avoiding serious side effects of an available treatment, (iii) improving the diagnosis of a serious disease where early diagnosis results in an improved outcome, (iv) decreasing a clinically significant toxicity of an available treatment, and (v) addressing an expected public health need.
Challenges Facing the American Healthcare System
Published in Kant Patel, Mark Rushefsky, Healthcare Politics and Policy in America, 2019
Fast-Track designation puts the approval of a new drug on a fast track based on the promising data based on animal or human clinical trials so the drug gets to the patient earlier than the time it would take to approve a new drug through a regular or normal approval process. The drug company in its application must request the fast-track process.
The politics of the big bang
Published in Rudolf Klein, The New Politics of the NHS, 2019
Fundholding covered a wide range of practice strategies, ranging from that of the innovative entrepreneurs to that of the cautious traditionalists. Nor was any comprehensive evaluation commissioned by the Government; indeed any such evaluation might have been difficult given that the conditions of fundholding kept on changing in the light of experience. However, from a prolixity of one-off studies,111 some tentative conclusions can be drawn. Most of the initial fears prompted by the introduction of fundholding proved unfounded. There was little evidence of ‘cream skimming’, i.e. selecting out expensive patients. Nor did fundholders as a whole appear to be short-changing their patients in search of surpluses: there was little, if any, difference in the increase in referrals to hospitals or prescribing costs between fundholders and other GPs. There was, however, some evidence that fundholders were able to buy preferential – i.e. fast track – access for their patients. Whether this should be considered as creating a ‘two-tier NHS’ is another matter. Individual GPs have always differed in their ability to negotiate access on behalf of their patients and, in this sense, the phenomenon of a ‘multi-tier NHS’ long predates fundholding.
Influence of fast-track programs on patient-reported outcomes in total hip and knee replacement (THR/TKR) at Swedish hospitals 2011–2015: an observational study including 51,169 THR and 8,393 TKR operations
Published in Acta Orthopaedica, 2020
Urban Berg, Annette W-Dahl, Ola Rolfson, Emma Nauclér, Martin Sundberg, Anna Nilsdotter
The study was based on questionnaires concerning the clinical pathway and care program in elective THR and TKR at Swedish hospitals (Kärrholm et al. 2016). The survey aimed to define when a fast-track program had been introduced. The operations at hospitals responding to the questionnaire were divided into 2 groups depending on whether the operations were made in a fast-track program or not. The definition of fast-track was based on the following criteria: (1) admission on the day of surgery; (2) mobilization within 3–6 hours after operation; and (3) functional discharge criteria in practice (Berg et al. 2018). The functional criteria were: ability to get in and out of bed independently, dress, go to the toilet, walk with crutches, and have sufficient pain treatment. The hospitals in the fast-track cohort reported a median LOS of 2–4 days and the hospitals in the not fast-track group 4–7 days.
Bias-corrected estimates of reduction of post-surgery length of stay and corresponding cost savings through the widespread national implementation of fast-tracking after liver transplantation: a quasi-experimental study
Published in Journal of Medical Economics, 2019
Chung-Ping A. Loh, Kristopher P. Croome, C. Burcin Taner, Andrew P. Keaveny
Evaluation of the potential cost savings from fast-tracking requires proper assessment of the reduction in LOS due to the program. Since patients selected for fast-tracking likely differ significantly from those who were not in terms of demographic characteristics (age, race, etc.), health measurements (BMI, raw MELD score, etc.), and surgery associated variables (operating time, etc.) that are highly correlated with post-operative LOS8–10, an uncontrolled comparison between these groups is likely to overstate the effect of the fast-track program. For example, the aforementioned MCF study reported that, among MCF’s LT patients during 2001–2007, the fast-tracked patients had a shorter post-transplant length of stay (LOS) compared to patients undergoing standard post-operative management (mean: 8.62 vs 18.76 days)1. In a Canadian study of live donor liver transplant recipients, fast-tracked patients had a much reduced post-transplant hospital stay than ICU patients (mean = 10.8 vs 21.3 days)11. Uncontrolled comparison was also employed in studies of early tracheal extubation programs12. Such a study design is common in the existing medical literature due to the non-experimental nature of the data available at hand.
Fear and forget: how anxiety impacts information recall in newly diagnosed cancer patients visiting a fast-track clinic
Published in Acta Oncologica, 2019
Minh Hao Nguyen, Ellen M. A. Smets, Nadine Bol, Madelon B. Bronner, Kristien M. A. J. Tytgat, Eugène F. Loos, Julia C. M. van Weert
The fast-track program starts with an intake consultation with a medical specialist to evaluate patients’ symptoms and performance status, followed by a nurse consultation to take their medical history. Sometimes additional imaging studies are scheduled. At noon, a multidisciplinary team discusses the diagnosis and formulates a treatment plan for each patient. In the afternoon, the diagnosis and proposed treatment plan are discussed with the patient by the same doctor who conducted the intake consultation, again followed by a nurse consultation for practical treatment information. Depending on the treatment plan, patients also see a colorectal surgeon, oncologist, or radiation oncologist to discuss treatment details. On average, patients have 4–6 consultations. All consultations during the patients’ visit were video-recorded for this study.