Inclusion-exclusion

WilS72 Williamson, S. G. The combinatorial analysis of patterns and the principle of inclusion-exclusion. Discrete Math. 1... 

Pharmacogenomics for Inclusion/Exclusion Criteria (or Stratification), or When Is It Appropriate for Pharmacogenetic and Pharmacogenomic Relationships to be Explored Post Hoc .210... 

Some believe that once a genotype or mRNA expression profile demonstrates a relationship with a phenotype of potential clinical importance, inclusion/exclusion criteria based on this association should be added to future studies. Others believe it is important to validate the association by replication prior to selecting patients on the basis of genotype or phenotype. 

Several participants felt that pharmacogenetics and pharmacogenomics should not be treated differently from any other covariate. In some cases, more confirmation would be required prior to using these data as inclusion/exclusion criteria (or for stratification), and pharmacogenetics and pharmacogenomics would be viewed as a covariate in the post hoc analyses. 

In this regard, the following factors should be considered in the context of stratification or use as inclusion/exclusion criteria. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

There are of course practical considerations in clinical research. We may find patient recruitment difficult in single centre studies and this is one of the major drivers to multicentre and multinational trials. Alternatively, we may need to relax the inclusion/exclusion criteria or lengthen the recruitment period. Unfortunately, while each of these may indeed increase the supply of patients they may also lead to increased variability that in turn will require more patients. A second issue is the size of the CRD which, if it is too small, will require a large number of patients. In such circumstances we may need to consider the use of surrogate endpoints (Section S.3.3.2). Finally, the standard deviation may be large and this can have a considerable impact on the sample size - for example, a doubling of the standard deviation leads to a four times increase in the... 

Question four addresses one of the most important issues in the critical assessment of economic analyses, that is, the issue of identification and inclusion/exclusion of resources. As discussed in the previous section, the actual scope of the resources included should match the (stated) perspective of the analysis. It is important to note that it is not always possible to measure and value all the costs and consequences of the alternatives however, a comprehensive list of the most important and relevant ones should be provided, along with justification for any major omissions. For example, a new drug has several side effects... 

Like in-text citations, the formatting of references requires great care. The appropriate use of punctuation, fonts, parentheses, in addition to the inclusion, exclusion, and sequencing of information (e.g., authors, title of article, title of journal, year of publication, page numbers), reveals your attention to detail, expected of good writers and by expert and scientific readers. 

It can provide a check that the patient about to be entered satisfies certain inclusion/exclusion criteria thus reducing the number of protocol violations. 

Consider the comparison of a new treatment A to an existing treatment B for lowering blood pressure in mild to moderate hypertension in the context of a clinical trial conducted across Europe. The characteristics of the population of mild to moderate hypertensive patients to be studied will be defined by the inclusion (and exclusion) criteria and may well contain several millions of individuals. In another sense this population will be infinite if we also include those patients satisfying the same inclusion/exclusion criteria in the future. Our clinical trial will, for example, also involve selecting a sample of say 200 individuals from this population and randomly assigning 100 to treatment group A and 100 to the treatment group B. 

Clinical study synopsis to obtain FDA input on inclusion, exclusion, and end points... 

Select patient population and define inclusion/exclusion criteria... 

Localized corrosion of passivating metals initiates at local heterogeneities, such as inclusions and second-phase precipitates as well as grain boundaries, dislocations, flaws, or sites of mechanical damage. In the case of stainless steel surfaces, pit initiation occurs at sites of MnS inclusions. Exclusion of inclusions and precipitates, nonequilibrium... 

In addition, the protocol should call for examination of the demographic characteristics of these patients, medical history, physical examination, and other patient characteristics known by the consultant clinicians and cited in the literature as possibly significant. Some of these may simply be recorded and later duly noted with relation to the test product s effects, and others may serve at the outset as part of the inclusion/exclusion criteria. As always, numerical definitions are more useful but may not be appropriate to all demographic criteria. 

Obviously, the inclusion/exclusion criteria should result in a patient population that is as large as is scientifically justifiable and desirable (i.e., large enough to detect the desired difference at the stated probability levels.) In the earliest clinical trial (phase 1), the potential risk entailed in administering a new... 

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