Phase iii trials
Neoadjuvant chemotherapy in locally advanced cancer cervix. A meta-analysis of phase III trials
... Results: Searching the above websites identified 7 phase III trials that fit with the current inclusion criteria. All the 7 trials included treatment arm for NACT. The other arms were either ...
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Using Bayesian adaptive designs to improve phase III trials : a respiratory care example
... of trials. It should be recognised that a large number of phase III trials fail to detect differences between treatment arms and therefore the example chosen is a common scenario, and more ...
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Safety data from the phase III Japanese ACHIEVE trial: part of an international, prospective, planned pooled analysis of six phase III trials comparing 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy for stage III colon cancer
... incidence of several key AEs, which included PSN, hand– foot syndrome and neutropenia. Among these AEs, PSN is the greatest concern for patients receiving oxalipla- tin-containing chemotherapy, and it was noteworthy that ...
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The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials
... in Phase III RCTs in schizophrenia were identified using a meta-analysis of more than 200 antipsychotic clinical tri- als in schizophrenia [22] and a literature research on pivotal Phase III ...
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Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
... In 2018, cetirizine ophthalmic solution 0.24% (Zerviate™) was approved by the Food and Drug Agency for the treatment of ocular itch associated with allergic conjunctivitis. Here, we report two Phase III ...
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Profile of aclidinium bromide in the treatment of chronic obstructive pulmonary disease
... Recent Phase III clinical trials showed a statistically sig- nificant improvement in trough FEV 1 relative to placebo, but the magnitude of benefit was somewhat less than that seen in clinical ...
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Selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women: focus on lasofoxifene
... the phase II comparative study and the phase III trials indicate that lasofoxifene has an improved efficacy on bone parameters (ie, markers of bone resorption and BMD) with significant ...
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Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis
... The results of this study suggested that a subset of MS patients with motor dysfunction and impaired walking responded to dalfampridine SR. Importantly, another group indistinguishable on the basis of clinical ...
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Emerging role of integrase inhibitors in the management of treatment-experienced patients with HIV infection
... in phase III ...Clinical trials in both treatment-naïve and -experienced patients have demonstrated raltegravir to be highly effective with an excellent tolerability profi le and no specifi c clinical ...
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Hepatic profile analyses of tipranavir in Phase II and III clinical trials
... five Phase IIb and III trials which comprised the clinical development program for ...these trials were highly treatment-experienced and received the approved dose of TPV/r 500/200 mg ...five ...
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Allocating the Sample Size in Phase II and III Trials to Optimize Success Probability
... observed phase II effect size was adopted to compute phase III sample size: being aware of the variability in effect size estimation, conservative sample size estimation strategies may be adopted, as ...
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<p>Treating advanced breast cancer with metronomic chemotherapy: what is known, what is new and what is the future?</p>
... in Phase III trials, combination with targeted agents (especially immune checkpoint inhibitors), and role in the adjuvant setting for patients who did not achieve pCR with neoadjuvant treat- ment, or ...
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Phase III Soft Tissue Sarcoma Trials: Success or Failure?
... of phase III drug trials performed in advanced STS over the past 30 years have recruited cohorts consisting of many different disease ...included trials recruited from a single specified ...
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Use of theragnostic markers to select drugs for phase II/III trials for Alzheimer disease
... the phase III trials (IDENTITY [Interrupting Alzheimer’s Dementia by Evalu ating Treatment of Amyloid Pathology] and IDENTITY-2) of the γ-secretase inhibitor semagacestat (LY450139) (Eli Lilly and ...
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Meta analysis of randomized phase II trials to inform subsequent phase III decisions
... when trials with more favor- able results are more likely to be published than those with less favorable results ...the trials should be symmetrically distributed about the estimates from lar- ger studies, ...
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Conditionally unbiased estimation in phase II/III clinical trials with early stopping for futility
... seamless phase II/III clinical ...a phase II trial separate to a confirmatory phase III trial, seamless phase II/III clinical trials combine aspects of both phases ...
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HORMONE THERAPY FOR MANAGEMENT OF PROSTATE CANCER
... by organizations such as the American Urological Association. The optimum duration of hormone therapy with radiation therapy will continue to be an area of research study. Lastly, continuous hormonal therapy has been the ...
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Profile of tofacitinib citrate and its potential in the treatment of moderate-to-severe chronic plaque psoriasis
... A Phase III study assessed its noninferiority (rather than superiority) at the higher dose to ...Clinical trials with selective JAK inhibitors are required to dissect key pathogenic ...
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Differential HbA1c response in the placebo arm of DPP-4 inhibitor clinical trials conducted in China compared to other countries: a systematic review and meta-analysis
... clinical trials conducted in China, the efficacy of DPP-4 inhibitors is weaker than that in trials conducted outside China ...DPP-4 trials in China in the ...
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Translation of academic medicinal products towards clinical practice
... controlled trials with ATMPs because of limited patient numbers and starting ...clinical trials to prove safety and efficacy when the feasibility to implement it in regular clinical care remains ...
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