The Cost–Time Index: A new method for measuring the efficiencies of recruitment-resources in clinical trials

2006 ◽  
Vol 27 (6) ◽  
pp. 494-497 ◽  
Author(s):  
Ken S. Ota ◽  
Leah Friedman ◽  
J. Wesson Ashford ◽  
Beatriz Hernandez ◽  
Allison L. Penner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
New Method ◽  
Time Index ◽  
The Cost

Stroke Prevention in Non-Valvular Atrial Fibrillation

1997 ◽  
Vol 17 (03) ◽  
pp. 166-169
Author(s):  
Judith O’Brien ◽  
Wendy Klittich ◽  
J. Jaime Caro
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Care Home ◽  
Relevant Literature ◽  
Clinical Trial Data ◽  
Outcome Data ◽  
Sensitivity Analyses ◽  
Bleeding Events ◽  
Discharge Data ◽  
The Cost

SummaryDespite evidence from 6 major clinical trials that warfarin effectively prevents strokes in atrial fibrillation, clinicians and health care managers may remain reluctant to support anticoagulant prophylaxis because of its perceived costs. Yet, doing nothing also has a price. To assess this, we carried out a pharmacoe-conomic analysis of warfarin use in atrial fibrillation. The course of the disease, including the occurrence of cerebral and systemic emboli, intracranial and other major bleeding events, was modeled and a meta-analysis of the clinical trials and other relevant literature was carried out to estimate the required probabilities with and without warfarin use. The cost of managing each event, including acute and subsequent care, home care equipment and MD costs, was derived by estimating the cost per resource unit, the proportion consuming each resource and the volume of use. Unit costs and volumes of use were determined from established US government databases, all charges were adjusted using cost-to-charge ratios, and a 3% discount rate was applied to costs incurred beyond the first year. The proportions of patients consuming each resource were estimated by fitting a joint distribution to the clinical trial data, stroke outcome data from a recent Swedish study and aggregate ICD-9 specific, Massachusetts discharge data. If nothing is done, 3.2% more patients will suffer serious emboli annually and the expected annual cost of managing a patient will increase by DM 2,544 (1996 German Marks), from DM 4,366 to DM 6,910. Extensive multiway sensitivity analyses revealed that the higher price of doing nothing persists except for very extreme combinations of inputs unsupported by literature or clinical standards. The price of doing nothing is thus so high, both in health and economic terms, that cost-consciousness as well as clinical considerations mandate warfarin prophylaxis in atrial fibrillation.

Diplomacy Beyond History: Analytic-Violence, Producer-Centred Research, India

2021 ◽  
pp. 097492842098307
Author(s):  
Deep K. Datta-Ray
Keyword(s):  
New Method ◽  
The West ◽  
History Of ◽  
The Right ◽  
Nuclear Diplomacy ◽  
The Cost ◽  
Insight Into

The history of Indian diplomacy conceptualises diplomacy racially—as invented by the West—and restrictively—to offence. This is ‘analytic-violence’ and it explains the berating of Indians for mimicking diplomacy incorrectly or unthinkingly, and the deleting, dismissing, or denigrating, of diplomatic practices contradicting history’s conception. To relieve history from these offences, a new method is presented, ‘Producer-Centred Research’ (PCR). Initiating with abduction, an insight into a problem—in this case Indian diplomacy’s compromised historicisation—PCR solves it by converting history’s racist rationality into ‘rationalities’. The plurality renders rationality one of many, permitting PCR’s searching for rationalities not as a function of rationality but robust practices explicable in producer’s terms. Doing so is exegesis. It reveals India’s nuclear diplomacy as unique, for being organised by defence, not offence. Moreover, offence’s premise of security as exceeding opponent’s hostility renders it chimerical for such a security is, paradoxically, reliant on expanding arsenals. Additionally, doing so is a response to opponents. This fragments sovereignty and abdicates control for one is dependent on opponent’s choices. Defence, however, does not instigate opponents and so really delivers security by minimising arsenals since offence is eschewed. Doing so is not a response to opponents and so maintains sovereignty and retains control by denying others the right to offense. The cost of defence is courage, for instance, choosing to live in the shadow of nuclear annihilation. Exegesis discloses Balakot as a shift from defence to offence, so to relieve the Bharatiya Janata Party’s (BJP) leadership of having to be courageous. The intensity of the intention to discard courage is apparent in the price the BJP paid. This included equating India with Pakistan, permitting it to escalate the conflict, and so imperiling all humanity in a manner beyond history.

Inferring age from otolith measurements: a review and a new approach

2004 ◽  
Vol 61 (7) ◽  
pp. 1269-1284 ◽  
Author(s):  
RIC Chris Francis ◽  
Steven E Campana
Keyword(s):  
Simulation Experiment ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
New Method ◽  
Population Parameters ◽  
Benefit Analysis ◽  
Mixture Analysis ◽  
New Approach ◽  
Individual Fish ◽  
The Cost

In 1985, Boehlert (Fish. Bull. 83: 103–117) suggested that fish age could be estimated from otolith measurements. Since that time, a number of inferential techniques have been proposed and tested in a range of species. A review of these techniques shows that all are subject to at least one of four types of bias. In addition, they all focus on assigning ages to individual fish, whereas the estimation of population parameters (particularly proportions at age) is usually the goal. We propose a new flexible method of inference based on mixture analysis, which avoids these biases and makes better use of the data. We argue that the most appropriate technique for evaluating the performance of these methods is a cost–benefit analysis that compares the cost of the estimated ages with that of the traditional annulus count method. A simulation experiment is used to illustrate both the new method and the cost–benefit analysis.

LARGE-SCALE CLINICAL TRIALS: ARE THEY WORTH THE COST?

1982 ◽  
Vol 382 (1 Sudden Corona) ◽  
pp. 411-422 ◽  
Author(s):  
Robert I. Levy ◽  
Edward J. Sondik
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
The Cost

scholarly journals Occlusion of left atrial appendage in patients with atrial fibrillation

2015 ◽  
Vol 18 (4) ◽  
pp. 104 ◽  
Author(s):  
O. N. Ganeeva
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
New Method ◽  
Step Process

The article reviews a new method of prophylaxis of thromboembolitic complications, specifically occlusion of left atrial appendage, in patients with atrial fibrillation. Indications and contraindications for the procedure, as well as a step-by-step process of the intervention itself are described. Special emphasis is placed on the up-to-date evidence and the review of clinical trials.

scholarly journals r2SCAN-3c: An Efficient “Swiss Army Knife” Composite Electronic-Structure Method

2020 ◽  
Author(s):  
Stefan Grimme ◽  
Andreas Hansen ◽  
Sebastian Ehlert ◽  
Jan-Michael Mewes
Keyword(s):  
Electronic Structure ◽  
Density Functional ◽  
Chemical Space ◽  
Noncovalent Interactions ◽  
New Method ◽  
Basis Set ◽  
Basis Set Superposition Error ◽  
Benchmark Database ◽  
The Cost ◽  
Conformational Energies

The recently proposed second revision of the SCAN meta-GGA density-functional approximation (DFA) {Furness et al., J. Phys. Chem. Lett. 2020, 11, 8208-8215, termed r<sup>2</sup>SCAN} is used to construct an efficient composite electronic-structure method termed r<sup>2</sup>SCAN-3c, expanding the "3c'' series (hybrid: HSE/PBEh-3c, GGA: B97-3c, HF: HF-3c) to themGGA level. To this end, the unaltered r<sup>2</sup>SCAN functional is combined with a tailor-made <br>triple-zeta Gaussian AO-basis as well as with refitted D4 and gCP corrections for London-dispersion and basis-set superposition error. The performance of the new method is evaluated for the GMTKN55 thermochemical database covering large parts of chemical space with about 1500 <br>data points, as well as additional benchmarks for noncovalent interactions, organometallic reactions, lattice energies of organic molecules and ices, as well as for the adsorption on polar salt and non-polar coinage-metal surfaces. These comprehensive tests reveal a spectacular performance and robustness of r<sup>2</sup>SCAN-3c for reaction energies and noncovalent interactions in molecular and periodic systems, as well as outstanding conformational energies, and consistent structures. At just one tenth of the cost, r<sup>2</sup>SCAN-3c provides one of the best results of all semi-local DFT/QZ methods ever tested for the GMTKN55 benchmark database. Specifically for reaction and conformational energies as well as for noncovalent interactions, the new method outperforms hybrid-DFT/QZ approaches, compared to which the computational savings are even larger (factor 100-1000).<br>In relation to other "3c'' methods, r<sup>2</sup>SCAN-3c by far surpasses the accuracy of its predecessor B97-3c at only about twice the cost. The perhaps most relevant remaining systematic deviation of r<sup>2</sup>SCAN-3c is due to self-interaction-error, owing to its mGGA nature. However, SIE is notably reduced compared to other (m)GGAs, as is demonstrated for several examples. After all, this remarkably efficient and robust method is chosen as our new group default, replacing previous low-level DFT and partially even expensive high-level methods in most standard applications for systems with up to several hundreds of atoms.<br><br>

scholarly journals r2SCAN-3c: An Efficient “Swiss Army Knife” Composite Electronic-Structure Method

2020 ◽  
Author(s):  
Stefan Grimme ◽  
Andreas Hansen ◽  
Sebastian Ehlert ◽  
Jan-Michael Mewes
Keyword(s):  
Electronic Structure ◽  
Density Functional ◽  
Chemical Space ◽  
Noncovalent Interactions ◽  
New Method ◽  
Basis Set ◽  
Basis Set Superposition Error ◽  
Benchmark Database ◽  
The Cost ◽  
Conformational Energies

The recently proposed second revision of the SCAN meta-GGA density-functional approximation (DFA) {Furness et al., J. Phys. Chem. Lett. 2020, 11, 8208-8215, termed r<sup>2</sup>SCAN} is used to construct an efficient composite electronic-structure method termed r<sup>2</sup>SCAN-3c, expanding the "3c'' series (hybrid: HSE/PBEh-3c, GGA: B97-3c, HF: HF-3c) to themGGA level. To this end, the unaltered r<sup>2</sup>SCAN functional is combined with a tailor-made <br>triple-zeta Gaussian AO-basis as well as with refitted D4 and gCP corrections for London-dispersion and basis-set superposition error. The performance of the new method is evaluated for the GMTKN55 thermochemical database covering large parts of chemical space with about 1500 <br>data points, as well as additional benchmarks for noncovalent interactions, organometallic reactions, lattice energies of organic molecules and ices, as well as for the adsorption on polar salt and non-polar coinage-metal surfaces. These comprehensive tests reveal a spectacular performance and robustness of r<sup>2</sup>SCAN-3c for reaction energies and noncovalent interactions in molecular and periodic systems, as well as outstanding conformational energies, and consistent structures. At just one tenth of the cost, r<sup>2</sup>SCAN-3c provides one of the best results of all semi-local DFT/QZ methods ever tested for the GMTKN55 benchmark database. Specifically for reaction and conformational energies as well as for noncovalent interactions, the new method outperforms hybrid-DFT/QZ approaches, compared to which the computational savings are even larger (factor 100-1000).<br>In relation to other "3c'' methods, r<sup>2</sup>SCAN-3c by far surpasses the accuracy of its predecessor B97-3c at only about twice the cost. The perhaps most relevant remaining systematic deviation of r<sup>2</sup>SCAN-3c is due to self-interaction-error, owing to its mGGA nature. However, SIE is notably reduced compared to other (m)GGAs, as is demonstrated for several examples. After all, this remarkably efficient and robust method is chosen as our new group default, replacing previous low-level DFT and partially even expensive high-level methods in most standard applications for systems with up to several hundreds of atoms.<br><br>

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

scholarly journals A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

2017 ◽  
Vol 21 (68) ◽  
pp. 1-170 ◽  
Author(s):  
Hazel Squires ◽  
Edith Poku ◽  
Inigo Bermejo ◽  
Katy Cooper ◽  
John Stevens ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Current Practice ◽  
Clinical Effectiveness ◽  
Posterior Uveitis ◽  
Sensitivity Analyses ◽  
Dexamethasone Implant ◽  
Intermediate Uveitis ◽  
Sham Procedure ◽  
The Cost

BackgroundNon-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex®; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis.Data sourcesElectronic databases and clinical trials registries including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the World Health Organization’s International Clinical Trials Registry Platform were searched to June 2016, with an update search carried out in October 2016.Review methodsReview methods followed published guidelines. A Markov model was developed to assess the cost-effectiveness of dexamethasone and adalimumab, each compared with current practice, from a NHS and Personal Social Services (PSS) perspective over a lifetime horizon, parameterised with published evidence. Costs and benefits were discounted at 3.5%. Substantial sensitivity analyses were undertaken.ResultsOf the 134 full-text articles screened, three studies (four articles) were included in the clinical effectiveness review. Two randomised controlled trials (RCTs) [VISUAL I (active uveitis) and VISUAL II (inactive uveitis)] compared adalimumab with placebo, with limited standard care also provided in both arms. Time to treatment failure (reduced visual acuity, intraocular inflammation, new vascular lesions) was longer in the adalimumab group than in the placebo group, with a hazard ratio of 0.50 [95% confidence interval (CI) 0.36 to 0.70;p < 0.001] in the VISUAL I trial and 0.57 (95% CI 0.39 to 0.84;p = 0.004) in the VISUAL II trial. The adalimumab group showed a significantly greater improvement than the placebo group in the 25-item Visual Function Questionnaire (VFQ-25) composite score in the VISUAL I trial (mean difference 4.20;p = 0.010) but not the VISUAL II trial (mean difference 2.12;p = 0.16). Some systemic adverse effects occurred more frequently with adalimumab than with placebo. One RCT [HURON (active uveitis)] compared a single 0.7-mg dexamethasone implant against a sham procedure, with limited standard care also provided in both arms. Dexamethasone provided significant benefits over the sham procedure at 8 and 26 weeks in the percentage of patients with a vitreous haze score of zero (p < 0.014), the mean best corrected visual acuity improvement (p ≤ 0.002) and the percentage of patients with a ≥ 5-point improvement in VFQ-25 score (p < 0.05). Raised intraocular pressure and cataracts occurred more frequently with dexamethasone than with the sham procedure. The incremental cost-effectiveness ratio (ICER) for one dexamethasone implant in one eye for a combination of patients with unilateral and bilateral uveitis compared with limited current practice, as per the HURON trial, was estimated to be £19,509 per quality-adjusted life-year (QALY) gained. The ICER of adalimumab for patients with mainly bilateral uveitis compared with limited current practice, as per the VISUAL trials, was estimated to be £94,523 and £317,547 per QALY gained in active and inactive uveitis respectively. Sensitivity analyses suggested that the rate of blindness has the biggest impact on the model results. The interventions may be more cost-effective in populations in which there is a greater risk of blindness.LimitationsThe clinical trials did not fully reflect clinical practice. Thirteen additional studies of clinically relevant comparator treatments were identified; however, network meta-analysis was not feasible. The model results are highly uncertain because of the limited evidence base.ConclusionsTwo RCTs of systemic adalimumab and one RCT of a unilateral, single dexamethasone implant showed significant benefits over placebo or a sham procedure. The ICERs for adalimumab were estimated to be above generally accepted thresholds for cost-effectiveness. The cost-effectiveness of dexamethasone was estimated to fall below standard thresholds. However, there is substantial uncertainty around the model assumptions. In future work, primary research should compare dexamethasone and adalimumab with current treatments over the long term and in important subgroups and consider how short-term improvements relate to long-term effects on vision.Study registrationThis study is registered as PROSPERO CRD42016041799.FundingThe National Institute for Health Research Health Technology Assessment programme.

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