Tests and Clinical Trials

Alzheimer's disease: clinical trials and drug development

F Mangialasche, A Solomon, B Winblad, P Mecocci… - The Lancet …, 2010 - Elsevier
... In this Review, we provide an update-to-date and comprehensive outline of the status of drug
development for Alzheimer's disease, focusing mainly on compounds being tested in human
beings (see webappendix for clinical trial registration details), and citing ...

Optimal two-stage designs for phase II clinical trials

R Simon - Controlled clinical trials, 1989 - Elsevier
... C, Turnbull BW: Confidence intervals for a binomial parameter following a multistage test with
application ... 58, 1983 7. Chang MN, O'Brien PC: Confidence intervals following group sequential
tests... JR, Nichol FR, Elfring GL, Weed SD: Multi-stage procedures for drug screening. ...

Some comments on frequently used multiple endpoint adjustment methods in clinical trials

AJ Sankoh, MF Huque, SD Dubey - Statistics in medicine, 1997 - Wiley Online Library
... Previous article in issue: Methods correcting for multiple testing: operating characteristics. ... Center
for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857 ...
that some adjustments of the observed p-values for multiplicity of tests may be ...

A multi‐center randomized trial of buprenorphine–naloxone versus clonidine for opioid, detoxification: findings from the National Institute on Drug Abuse Clinical Trials …

W Ling, L Amass, S Shoptaw, JJ Annon… - …, 2005 - Wiley Online Library
... of dependence diagnoses for in-patient and out-patient participants, respectively, are: alcohol,
12% 5.2%; cannabis, 6.2%, 6.1%; cocaine ... Differences in demographic and drug use history
variables between conditions at baseline were evaluated separately using t-tests and χ ...

Clinical trial of indomethacin in Alzheimer's disease

J Rogers, LC Kirby, SR Hempelman, DL Berry… - Neurology, 1993 - AAN Enterprises
... hypothesis of a beneficial effect of indomethacin, and they approached signif- icance by a
two-tailed test... Over a battery of cognitive tests, indomethacin in doses of 100 to 150 mg/d
appeared to ... Second, the choice of anti-inflammatory drug for testing should be carefully weighed ...

Approaching a consensus cognitive battery for clinical trials in schizophrenia: the NIMH-MATRICS conference to select cognitive domains and test criteria

MF Green, KH Nuechterlein, JM GoldDM Barch… - Biological …, 2004 - Elsevier
... new source of variability (form-to-form variability) and a potential drop in test–retest reliability. ...
Hence, for the purposes of evaluating and selecting tests, the committee did not specify a ... The
possibility that a cognitively enhancing drug may be required to demonstrate change on a ...

Age‐associated memory impairment: Proposed diagnostic criteria and measures of clinical change—report of a national institute of mental health work group

T Crook, RT Bartus, SH Ferris, P Whitehouse… - 1986 - Taylor & Francis
... In considering these possibilities, several important differences between animal and human drug/
test protocols can be identified, and at least two points are particularly im- portant here: ... 2. Tests
used to evaluate drug effects in the clinic frequently have no clear relationship to ...

Blood pressure, stroke, and coronary heart disease: part 2, short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context

R Collins, R Peto, S MacMahon, J Godwin, N Qizilbash… - The Lancet, 1990 - Elsevier
... In general, however, such tests of heterogeneity between many different trials are of limited value ...
trials20 is almost certain to exist no matter what a formal test of heterogeneity ... and (iv) non-vascular
death in the unconfounded randomised trials of antihypertensive drug treatment. ...

Participation of patients 65 years of age or older in cancer clinical trials

JH Lewis, ML Kilgore, DP Goldman… - Journal of Clinical …, 2003 - ascopubs.org
... of the elderly in the United States population with each cancer type using one-sample binomial
tests... treatment despite a lack of evidence that age is a risk factor for drug toxicity or ... on the elderly,
or changes in study design or requirements, many cancer clinical trials may fail to ...

[BOOK] Clinical trials: a practical approach

SJ Pocock - 2013 - books.google.com
... trials can be used to evaluate aspects of treatment other than drug therapy. ... Statistical methods
should be applied to the results in order to test the prespecified ... protocol | CONDUCT THE TRIAL
good organization | ANALYZE THE DAIA : descriptive statistics, tests of hypotheses ...

Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials.

EF Juniper, GH Guyatt, RS Epstein, PJ Ferrie… - Thorax, 1992 - thorax.bmj.com
... was devel- oped in an interviewer and self adminis- tered form and tested for comprehen ... relatives
of previous subjects, from patients who had had a methacholine inhalation test in the ... estab- lished
protocol;" a brief asthma history was taken and current drug requirements were ...

One-sample multiple testing procedure for phase II clinical trials

TR Fleming - Biometrics, 1982 - JSTOR
... appropriately have expressed concern about the possibil- ity of early termination when early
data support drug effectiveness. ... de test multiple sur un echantillon qui emploie au dernier examen
la methode du test standard sur ... Repeated significance tests on accumulat- ing data. ...

The two-period change-over design and its use in clinical trials

JE Grizzle - Biometrics, 1965 - JSTOR
... can be estimated separately under certain assumptions, to con- struct a proper error term for
the test of equality ... the direct effect of the 1-th drug, X, = the residual effect of the 1-th drug, and
eiik ... The contrasts for making both of these tests are estimable under the model assumed. ...

Antiretroviral drug resistance testing in adults with HIV infection: implications for clinical management

MS Hirsch, B Conway, TD Richard, VA Johnson… - Jama, 1998 - jamanetwork.com
Objectives.—To review current knowledge of the biology and clinical implications of human
immunodeficiency virus (HIV) resistance to antiretroviral drugs, des.

[HTML] Antiretroviral drug resistance testing in adults infected with human immunodeficiency virus type 1: 2003 recommendations of an International AIDS Society- …

MS Hirsch, F Brun-Vézinet, B Clotet… - Clinical Infectious …, 2003 - academic.oup.com
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Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial

…, S Forsberg, K Koota, C Friman, FIN-RACo trial Group - The Lancet, 1999 - Elsevier
... 25 However, the patient might be or might not be on any drug treatment, and fatigue (a
vaguely defined criterion) and duration definition were excluded. ... Categorical data were
analysed by χ 2 tests or Fisher's exact test... α was set at 0·05 for all tests...

Clinical trial of abstinence-based vouchers and cognitive-behavioral therapy for cannabis dependence.

AJ Budney, BA Moore, HL Rocha… - … of consulting and clinical …, 2006 - psycnet.apa.org
... National Institute on Alcohol Abuse and Alcoholism, 1992a, 1992b), were adapted for cannabis
dependence ... used to support treatment goals of positive lifestyle change and increasing
drug-free activities ... an assess- ment, the TLFB was used to collect data on marijuana and other ...

[HTML] National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working …

AH Filipovich, D Weisdorf, S Pavletic, G Socie… - Biology of blood and …, 2005 - Elsevier
... at least 1 distinctive manifestation, with the diagnosis confirmed by pertinent biopsy, laboratory
tests, or radiology ... lamp examination with mean values of 6 to 10 mm on the Schirmer test is
sufficient ... both acute and chronic GVHD (as well as other causes, such as drug side effects ...

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working …

GJ Bubley, M Carducci, W Dahut, N Dawson… - Journal of Clinical …, 1999 - ascopubs.org
... on phase II trials and using more stringent criteria for better accuracy in selecting which drug
will undergo ... be less prone to extremes of patient selection bias and also serve better to test the
“real ... can still be of use as an aid in determining which agents should be tested in phase ...