Examining the Effect of Teleconferences on Oncology Phase 1 Trials.

Examining the effect of teleconferences on oncology phase 1 trials.

J Cancer. 2013; 4(6): 464-7
McKane A, Sima C, Fleck S, Weiss GJ

Objective: Phase 1 clinical trials are the first stage of clinical development of an investigational agent. Because the trials often take place at several geographically dispersed sites, safety teleconferences are held to update investigators and the drug sponsor on safety information and other pertinent business related to the trial conduct. Here we examine associations between the frequency of teleconferences and other clinical trial factors on trial conduct efficiency. Methods: We examined Phase 1 clinical trials for patients with solid tumors opened for enrollment at a single, non-profit cancer center in Arizona (Center) that had completed at least three dose levels. The following information was included: safety teleconference frequency, whether or not the sponsor or contract research organization sent follow-up requests for updates on patient accrual, and safety outside of scheduled safety teleconferences. The dose escalation scheme, route of study drug administration and formulation type (e.g. oral targeted therapy or monoclonal antibody) was also included. Results: Forty-nine Phase 1 studies were examined for inclusion. The majority of safety teleconferences were regularly scheduled (81.6%) with most taking place bi-weekly (46.9%). Additional solicitation for updates outside of scheduled safety teleconferences were requested during the conduct of 31 (63.3%) studies. None of the factors analyzed were significantly associated with accrual, subject dosing, and dose escalation. Conclusion: We found that the frequency of teleconferences does not appear to expedite phase 1 study accrual, subject dosing, or dose escalation in the first 3 cohorts of a phase 1 clinical trial. HubMed – drug

Factors associated with mortality in tuberculosis patients.

J Res Med Sci. 2013 Jan; 18(1): 52-5
Alavi-Naini R, Moghtaderi A, Metanat M, Mohammadi M, Zabetian M

Tuberculosis (TB) is one of the main causes of morbidity and mortality in different societies. Understanding factors leading to death following diagnosis of TB is important to predict prognosis in TB patients. The aim of this study was to identify common risk factors associated with death in patients with an in-hospital diagnosis of TB, in a city in Iran with the highest prevalence and incidence of TB in the country.A retrospective study was conducted at a university-affiliated hospital, Zahedan, in the south-east of Iran, which is a referral center for TB. To identify factors leading to death, medical records of 715 patients ?15 years old with pulmonary TB from February 2002 to February 2011 have been evaluated. Registered factors included smoking, human immune deficiency virus (HIV) infection, using drugs, lung cancer, drug hepatitis following anti-TB medications, diabetes mellitus, previous TB treatment, anemia; and results of sputum smears. Univariate comparison and multiple logistic regression were performed to identify factors associated with mortality in TB patients.Among 715 registered TB patients, 375 (52.5%) patients were male; among those, 334 (53%) were in the alive group and 41 (54%) in the death group. Seventy-five (10.5%) of the total number of TB patients died during TB treatment. The multivariate model showed that anemia (AOR: 19.8, 95% CI: 5.6-35.5), positive sputum smear (AOR: 13.4, 95% CI: 6.8-33.6), smoking (AOR: 12.9, 95% CI: 3.9-27.3), drug hepatitis (AOR: 12.3, 95% CI: 6.7-24.7), diabetes mellitus (AOR: 9.7, 95% CI: 2.9-32.0), drug use (AOR: 7.8, 95% CI: 2.4-25.5), and history of previous TB (AOR: 6.8, 95% CI: 2.2-21.3) were major risk factors for death in TB patients.Monitoring co-morbid conditions like diabetes mellitus and anemia are important to reduce death rate in TB patients. Preventive measures for smoking and drug addiction also play an important role to decrease mortality. Follow-up of patients with previous TB treatment is recommended. HubMed – drug

Current perspectives on treatment of hypertensive patients with chronic obstructive pulmonary disease.

Integr Blood Press Control. 2013; 6: 101-9
Chandy D, Aronow WS, Banach M

Systemic hypertension and chronic obstructive pulmonary disease (COPD) frequently coexist in the same patient, especially in the elderly. Today, a wide variety of antihypertensive drugs with different mechanisms of action are available to the prescribing physician. In addition, combination drugs for hypertension are becoming increasingly popular. Certain antihypertensive drugs can affect pulmonary function. Therefore the management of such patients can present therapeutic challenges. We have examined the literature pertaining to the use of antihypertensive drugs in patients with systemic hypertension and coexisting COPD. Although data are often limited or of poor quality, we have attempted to review and then provide recommendations regarding the use of all the specific classes of antihypertensive drug therapies including combination drugs in patients with COPD. The antihypertensive agents reviewed include diuretics, aldosterone receptor blockers, beta blockers, combined alpha and beta blockers, angiotensin-converting enzyme inhibitors, angiotensin II antagonists, calcium channel blockers, alpha-1 blockers, centrally acting drugs, direct vasodilators, and combinations of these drugs. Of these classes, calcium channel blockers and angiotensin II antagonists appear to be the best initial choices if hypertension is the only indication for treatment. However, the limited data available on many of these drugs suggest that additional studies are needed to more precisely determine the best treatment choices in this widely prevalent patient group. HubMed – drug

A review of the gastrointestinal therapeutic system (GITS) formulation and its effectiveness in the delivery of antihypertensive drug treatment (focus on nifedipine GITS).

Integr Blood Press Control. 2013; 6: 79-87
Meredith PA, Elliott HL

Hypertension treatment guidelines do not discriminate within drug classes and, furthermore, do not consider whether or not all of the formulations of any given drug licensed for once-daily administration can be considered to be therapeutically interchangeable. This article focuses on this issue with respect to nifedipine and the development of the gastrointestinal therapeutic system (GITS) formulation. Nifedipine GITS is regarded as the gold standard once-daily formulation of nifedipine and, as such, it is anticipated that alternative formulations will be therapeutically equivalent to nifedipine GITS. In general, this depends on demonstrating pharmacokinetic bioequivalence. This article is intended to focus attention on generic substitution and, in particular, on aspects of the scientific basis for the substitution of generic products in place of branded products. Such substitution is required for cost-saving or cost-containment reasons and is justified on the basis that the generic (substitute) drug is “therapeutically” equivalent to the branded drug. Unfortunately, there are serious shortcomings in the current methods of assessment insofar as they are typically based on statistical comparisons of average pharmacokinetic parameter values, using arbitrary comparative criteria. This article illustrates the shortcomings of the current approaches to generic substitution and concludes that, in regulatory terms, either more rigorous pharmacokinetic criteria are required or pharmacodynamic indices should be added to reinforce the regulatory criteria. Generic substitution is a balancing act but, at the moment, the cost issue is dominant. To restore the balance, equivalent efficacy must be confirmed. At present, therefore, in the absence of such regulatory rigor, the obvious course is to prefer the branded product, the therapeutic efficacy of which (including outcome benefits) has been established. HubMed – drug

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