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In this case the null hypothesis of no difference between groups MULTIPLE COMPARISONS is then rejected quality 500 mg ceftin. In fact for k (assumed independent) outcome measures the false positive tive these issues are reviewed by Proschan and Waclawiw generic ceftin 250mg without prescription. Clearly purchase ceftin 500 mg fast delivery, the false positive rate increases as the number of comparisons made increases purchase ceftin 250 mg with mastercard. SUBGROUP ANALYSIS In order to retain the false positive rate as In designing a RCT buy 500mg ceftin visa, sample size is usually deter- 100α% the Bonferroni correction is often sug- mined by considering a clinically worthwhile gested order ceftin 500 mg with mastercard. This implies only declaring differences as effect which will be estimated from the trial data statistically significant at the 100α% level if the by a comparison of all patients randomised to one observed p-value <α/k. Equiv- that the precision with which this effect size is alently, and preferably, multiply the observed p- estimatedmaybeimprovedbyastratifiedanal- value by k and declare this significant if less ysis adjusted for baseline prognostic variables than α. However, if treat- One approach that has been used to overcome this ments are compared within these strata (thereby difficulty is to quote 99% CIs rather than 95% CIs ignoring information on patients not in that stra- whenever more than a single outcome is regarded tum) it is clear that the patient numbers must be as primary. Thus any such Study Group70 report 21 distinct endpoints, comparisons will usually lack sufficient statistical ranging from fatal myocardial infarction to death power and hence may be unreliable. In some cir- between taking no account of the multiplicity cumstances, one of these subgroup comparisons and retaining 0. For example, Green22 highlights group analysis can appear to favour one treatment this problem with respect to trials of a facto- in one subgroup and the other in the other sub- rial design. This may then lead to a false conclusion 38 TEXTBOOK OF CLINICAL TRIALS that the new treatment works for one group but COMPETING RISKS not for the other. If a subgroup analysis is planned for at the design stage, adjustment for this should In some situations, a patient may fail following be built into the sample size considerations. If relapse is the outcome of interest Although the standard of reporting of randomised in the clinical trial, then usually it is the first event controlled trials has improved in many medi- that is of primary importance to the clinician. There are also many situations in 1A monoclonal therapy was thought to be most which inappropriate and substandard analyses are effective against individually dispersed cells and conducted. Particular examples include statisti- less effective against local satellite tumour nod- cal significance tests of pre-randomisation (base- 78 ules or cell aggregates. Since the 17-1A anti- line) variables, often describing demographic and body should be most effective in preventing or patient eligibility criteria in the different treat- delaying distant metastases after surgery, distant ment groups, despite the allocation to groups metastasis as a first event was thus a key endpoint having been made by randomisation so that any 75 in this trial. In the analysis of competing patterns of failure, the Kaplan–Meier method and the associated OTHER MISUSED APPROACHES logrank test are frequently used to estimate TO ANALYSIS the comparative rates of, for example, local recurrence and distant metastasis in patients Anderson76 catalogues some commonly misused receiving alternative treatments for their cancer in approaches used in the analysis of clinical trials. In one, local recurrence These include in, for example, cancer clinical as the first event is taken as the event of trials with dual endpoints of tumour response interest. In this situation, patients who do not and overall survival, the analysis of survival by have a local recurrence, or who have local tumour response itself. In these cases survival is recurrence as a second or subsequent event, compared between those patients who respond irrespective of whether or not they have distant and those who do not. Anderson states categorically that such metastasis as the first event is taken as the event comparisons are wrong unless an appropriate of interest. Similar considerations apply if comparisons are made between groups established on the basis incidence functions and comparisons between of the amount of (protocol defined) treatment groups via the test developed by Gray. Indeed a whole new industry of Clinical Research There are many statistical packages available for Organisations (CROs) has developed to guarantee the summary and analysis of clinical trials and this process. Further, the Regulatory Agencies additional features are continually being added. Information from randomised controlled trials Over the last decades, there have been many provides key information when the pharmaceu- statistical developments that have impacted on, tical and allied industries apply to register a for example, the endpoints that can be assessed, new drug or device with the relevant regulatory the design, size, analysis and summary. The authorities themselves impose include the Kaplan–Meier method for summaris- certain constraints on the way in which trials ing survival time studies, the logrank test and are conducted – these will include basics with most influential of all the associated Cox pro- respect to a justification of a sample size for portional hazards model which allows between- the trial but will also specify standards. The Cox model can also accommodate time-dependent variables, that is variables that PRINCIPLES OF QUALITY DATA are assessed post-randomisation. These devel- MANAGEMENT opments would have remained theoretical in nature but for parallel developments in statisti- In clinical trials, subjects are usually entered cal software.

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When designing a clinical trial it is not large then it should be of sufficient is often convenient to think in hypothesis-testing clinical generic ceftin 500 mg without a prescription, scientific or public health importance to terms and so set α and β and a specific effect warrant the consequentially large trial that will size for consideration cheap ceftin 250 mg without prescription. If of a trial cheap ceftin 500 mg with visa, α and β are typically taken as small order ceftin 500 mg on line, the anticipated effect is large discount ceftin 500mg on-line, the RCT will be for example α = 0 ceftin 500 mg without a prescription. In either case, a realistic If the trial is ultimately to compare the means view of the possible effect size is important. In this way the sensitivity of the resulting sample sizes to this range of values will provide 2 4(z1−α/2 + z1−β) options for the investigating team. In circumstances where of the standardised normal distribution for given there is little prior information available, Cohen47 α and β. For large, moderate their means (µA − µB) and σ is the standard deviation (SD) of the endpoint variable which is and small sizes of of 1, 0. However, for large simple trials, the adapt to the specific trial design (parallel group, equivalent of effects sizes as small as = 0. Once the trial has been concluded, then a formal A good clinical trial design is that which will test of the null hypothesis of no difference answer the question posed with the minimum between treatments is often made. An excessively large later that it is always important to provide an trial not only incurs higher costs but is also uneth- associated confidence interval for the estimate of ical. Too small a trial size leads to inconclusive treatment difference observed. The test of the null results, since there is a greater chance of missing hypothesis has an associated false positive rate the clinically important difference, resulting in a GENERAL ISSUES 31 waste of resources. This independent DMC reviews reports on trial DATA MONITORING COMMITTEES progress prepared by the data centre teams and makes specific recommendations to the relevant It is clear that a randomised controlled trial is a trial coordinating group. Early thoughts on the major undertaking, which clearly involves human structure of DMCs for the UK Medical Research subjects in the process. Thus, as we have stated, Council Cancer Therapy Committee are provided it is important that some form of equipoise in 52 by Parmar and Machin. Indeed the very point of a SAFETY clinical trial is to upset the equipoise in favour of the best (if indeed one truly is) treatment. Although an IDMC will be concerned with Clearly there will be circumstances when the relative efficacy of the treatments under such early information may be sufficient to test, issues of safety will also be paramount in convincingly answer the question posed by the many circumstances. In which case the trial should close to may dominate the early stages of a trial when further patient entry. One circumstance when relatively new and untested treatment modalities this will arise is when the actual benefit far are first put into wider use, whereas in the exceeds that which the design team envisaged. In contrast, after early results on 43 patients suggested serious safety issues may force a recommendation a substantial benefit to adjuvant intra-arterial for early closure of the trial even in situations iodine-131-labelled lipiodol. Their decision was where early indications of benefit in terms of subsequently criticised by Pocock and White,50 efficacy are present. A confirmatory trial is these possibly conflicting aspects when making now in progress to substantiate or refute these their report. Nevertheless in this, and for the majority of clinical trials, it is clearly important to monitor INTERIM ANALYSIS AND EARLY the accumulating data. It has also been recognised STOPPING RULES that such monitoring should be reviewed (not by the clinical teams involved in entering patients At the planning stage of a clinical trial the design into the trial themselves) but by an independent team will be aware of the need to monitor the DMC. The membership and remit of a DMC will progress of the trial by reports to an IDMSC. On usually depend on the particular trial(s) under these occasions the data centre responsible for the 32 TEXTBOOK OF CLINICAL TRIALS conduct of the trial will expect to prepare reports published and negative studies tend not to be on many aspects of trial progress including published presents a distorted view of the true especially safety and efficacy. This approach to reporting is par- often detailed in the trial protocol. The detail may ticularly important for clinical trial overviews specify those aspects that are likely to be of major and meta-analysis where it is clearly impor- concern and also the timing (often expressed in tant to be able to include all relevant stud- terms of patient numbers or events observed) of ies (not just the published ones) in the overall such reports.

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The main points cho- sen were Zu San Li (St 36) 250 mg ceftin amex, Bai Hui (GV 20) buy 500mg ceftin amex, Yin Ling Quan (Sp 9) cheap ceftin 500mg on-line, and Lie Que (Lu 7) purchase ceftin 500mg fast delivery. The auxiliary points were Pi Shu (Bl 21) order ceftin 250 mg online, Guan Yuan (CV 4) cheap 500 mg ceftin fast delivery, Shen Shu (Bl 23), and Zhong Ji (CV 3). In addition to needling the above points, indirect ginger moxibustion was per- formed on Zu San Li, Pi Shu, and Guan Yuan in order to warm and supplement the spleen and kidneys. After five treatments, the patient could wake himself to urinate once per night and, there- fore, did not wet the bed. Therefore, treatments were continued for five more times, at which time the case was considered cured. Representative Case Histories 199 Case 23:23 This patient was a 14 year-old male student who was initially seen on March 12, 1985. This patient had suffered from enuresis for 10 years and had tried many treatments without success, including Chinese and Western medicine, herbal formulas, and empirical formulas. This individual had enuresis one time per night which, in winter, increased to three times per night. The young man had a lusterless, yellow facial complexion, a fatigued spirit, an emaciat- ed body, torpid intake, a pale tongue with thin, white fur, and a fine pulse. After the doctor used scalp acupuncture on Zu Yun Gan Qu (Foot Motor Sensory Area) one time, the patient had enuresis only one time in 2-3 nights. After the second treatment, the patient had enuresis one time in one week. A fourth treatment was given to secure the treatment results, after which time this case was considered cured. Tuina Case 24:24 This patient was an 11 year-old boy who was first examined on August 11, 1991. The child had suffered from enuresis since infancy without interruption. This enuresis was accompanied by emacia- tion, a lusterless facial complexion, torpid intake, a pale tongue with thin, white fur, and a fine, deep pulse. The following points were treated with tuina: Zhong Wan (CV 12), Qi Hai (CV 6), Guan Yuan (CV 4), Zhong Ji (CV 3), Zu San Li (St 36), San Yin Jiao (Sp 6), Bai Hui (GV 20), Ming Men (GV 4), Pang Guang Shu (Bl 28), and Ba Liao (Bl 31-34). After one treatment, the enuresis was decreased to two times and the child was able to wake himself to urinate. Treatment was continued for another seven days to secure the therapeutic results. The next visit after 14 days showed that the enuresis had reap- peared after the child forgot to urinate before climbing a tree. The previous method was used for seven more days, and a follow-up visit six months later showed no recurrence. The child had had enuresis since infancy and had used many formulas without success. The patient had enuresis 1-2 times per night, frequent, short urination during the day that looked like rice-washing water, devitalized appetite, bright white facial complexion, fatigued essence spirit, lack of strength when moving about, a pale tongue with thin, white fur, and a slow, deep, forceless pulse. Based on these findings, her TCM pattern was discriminated as lower origin vacuity cold and spleen qi vacuity weakness and the treatment principles were to warm the kidneys and secure and contain, fortify the spleen and boost the qi. Tuina consisted of rubbing the following points for two minutes each: Dan Tian (CV 4-6), Guan Yuan (CV 4), Qi Hai (CV 6), San Yin Jiao (Sp 6), and Gui Wei (GV 1). Then the pushing method was used on the following areas: Shen Shui (Kidney Water), 200 times with supplementation method, Xiao Chang (Small Intestine), 100 times with draining method, and Pi Tu (Spleen Earth), 200 times with supplementation method. After three treatments, the little girl would respond when the parents called her to wake to urinate, and her daytime urination was not as frequent and was less in amount. After continuing for seven treatments, her appetite had returned to normal and her enuresis was cured. Combined therapies Case 26:26 This patient was a six year-old male whose initial visit occurred on June 23, 1994.

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