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PubMed2001

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

We report on recommendations from a National Institutes of Health Workshop on methods for evaluating the use of surrogate endpoints in clinical trials, which was attended by experts in biostatistics and clinical trials from a broad array of disease areas. Recent advances in biosciences and technology have increased the ability to understand, measure, and model biological mechanisms; appropriate application of these advances in clinical research settings requires collaboration of quantitative and laboratory scientists. Biomarkers, new examples of which arise rapidly from new technologies, are used frequently in such areas as early detection of disease and identification of patients most likely to benefit from new therapies. There is also scientific interest in exploring whether, and under what conditions, biomarkers may substitute for clinical endpoints of phase III trials, although workshop participants agreed that these considerations apply primarily to situations where trials using clinical endpoints are not feasible. Evaluating candidate biomarkers in the exploratory phases of drug development and investigating surrogate endpoints in confirmatory trials require the establishment of a statistical and inferential framework. As a first step, participants reviewed methods for investigating the degree to which biomarkers can explain or predict the effect of treatments on clinical endpoints measured in clinical trials. They also suggested new approaches appropriate in settings where biomarkers reflect only indirectly the important processes on the causal path to clinical disease and where biomarker measurement errors are of concern. Participants emphasized the need for further research on development of such models, whether they are empirical in nature or attempt to describe mechanisms in mathematical terms. Of special interest were meta-analytic models for combining information from multiple studies involving interventions for the same condition. Recommendations also included considerations for design and conduct of trials and for assemblage of databases needed for such research. Finally, there was a strong recommendation for increased training of quantitative scientists in biologic research as well as in statistical methods and modeling to ensure that there will be an adequate workforce to meet future research needs.

Antiviral Agents↗
PubMed2000

The most important changes in the international ECC and CPR guidelines 2000.

Many people involved with resuscitation have specific interests and enthusiasm. They will review the new guidelines to see how their favorite interventions fared. This essay lists a number of the new guidelines that merit special attention: support for family presence at resuscitations, pronouncing death at the scene rather than after futile transport efforts, honoring advance directives, comparable effectiveness of bag-mask ventilation versus tracheal intubation, revision of compression rates and compression-ventilation ratios, and devices to confirm tracheal intubation and prevent tube dislodgment. Even more important are the new principles and concepts that the International Guidelines 2000 endorse: international guideline science, international guideline development, evidence-based guidelines, training by objectives, expanded scope of ECC to first aid and periarrest conditions, avoidance of false-negative (type II) errors, video-mediated instruction, and a philosophy to 'do no harm.' The number and magnitude of these new guidelines reflect the dynamic nature of resuscitation at the start of the 21st century. There is great optimism that these new and revised guidelines will help achieve our ultimate objective. This objective is to be ready when fate brings some lives to a premature end. If we are, we can restore more of these people to a high-quality life, ready for many more years of living.

Humans↗
PubMed2002

Evaluation of candidates for long-term ventilation.

This article considers the evaluation of patients prior to institution of long-term ventilation (LTV). LTV has evolved from a concept of necessity ventilation to a more satisfactory approach of preventive LTV, enabled by the impressive development of noninvasive mechanical ventilation (NIV). Due to its convenience and efficacy, and its safety compared with invasive ventilation, NIV has rapidly gained popularity among patients with chronic respiratory failure (CRF) requiring intermittent ventilatory assistance. Evaluation of candidates for LTV involves clinical and laboratory evaluations and sleep monitoring. It includes consideration of the etiology of CRF, be it restrictive lung disease, chronic obstructive pulmonary disease, obesity or other cause, and considers the feasibility of LTV as well as its desirability.

Chronic Disease↗
PubMed2004

Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial.

In November 2002, an advisory board meeting was convened by Novartis Pharma to provide recommendations and rationale for clinical trials designed to evaluate new treatments, such as TCH346, for amyotrophic lateral sclerosis (ALS). In terms of selecting appropriate outcome measures, the panel recommended the use of the ALS Functional Rating Scale (ALSFRS-R) to measure primary endpoints. A review of other key issues in this area including regional variations in the epidemiology, diagnosis and management of ALS, defining patient populations and doses of trial medication, and accommodating the likelihood of co-medication with pre-existing treatment in trial design, are discussed.

Amyotrophic Lateral Sclerosis↗
PubMed2004

Review article: towards the optimization of symptom evaluation in reflux disease.

A recent workshop has taken stock of the processes used for the evaluation of reflux disease symptoms. Such evaluations are vital both for routine clinical practice and for the critical assessment and comparison of therapeutic options. The workshop endorsed the importance of the assessment of symptom patterns for the diagnosis of reflux disease. Patient self-report symptom questionnaires were considered to be potentially valuable instruments, but have been researched relatively little in reflux disease. On the basis of a survey of the literature and data from generic methodological research, the workshop concluded that virtually all trials of the therapy of reflux disease have used too few response options for a sensitive definition of symptom status, and recommended that six to seven response options be used. Modified Likert scales with defined individual response options and structured patient self-report, rather than physician assessment, were considered to be the best approaches. These views on symptom status assessment are not reflected fully in the current practice of reflux disease clinical trials. Furthermore, the terminology used to describe symptom status is frequently ambiguous or tautological. Quality of life measures were acknowledged as valid and useful secondary measures of therapeutic benefit. By contrast, evaluation of the state of the art of assessment of patient satisfaction with therapy led to the conclusion that the methodology for this particular assessment was still in its infancy. The outputs of the workshop revealed many aspects of the assessment of reflux disease that would benefit from further research and development. A report on the detailed outputs of the workshop has been published recently.

Clinical Trials as Topic↗
PubMed1995

Length of incubation time for human immunodeficiency virus cultures.

Qualitative human immunodeficiency virus culture is a slow, labor-intensive, and expensive procedure, yet critical for the diagnosis of infants born to human immunodeficiency virus-seropositive mothers. We report that the cultures can be terminated at day 21 with minimal false-negative results but with considerable savings in both time and money.

Child↗
PubMed1997

Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis.

BACKGROUND: We have previously reported how the SCORAD index was designed. This cumulative index combines objective (extent and intensity of lesions) and subjective (daytime pruritus and sleep loss) criteria. AIMS: To study interobserver variability in scoring for objective SCORAD criteria and to optimize the scoring guidelines. MATERIAL AND METHODS: Three scoring sessions were organized in 1993-1994 in Hamburg, Bordeaux and Rotterdam totalizing 19 patients (14 children and 5 adults) and 23 physicians, among whom 12 participated in at least 2 scoring sessions; 169 evaluation sheets have been processed using the SCORAD File Marker Pro software. At each session, total body photographs and close-up views were taken of each patient, and this material was reviewed at the final evaluation. RESULTS: The extent of lesions according to the rule of nines showed interobserver variability mostly for patients with lesions of moderate intensity involving 20-60% of body surface. Intensity items were scored with more consistency overall, but variations subsided especially for oozing/crusts and lichenifications. Low and high scorer profiles and the benefit of training were noted. CONCLUSIONS: This study has allowed to optimize clinical scoring using the SCORAD system. A proposal has been made to grade the severity of atopic dermatitis according to objective criteria in three groups for inclusion in clinical trials. The SCORAD index remains the major criterion for follow-up in trials.

Adolescent↗
PubMed2004

Identifying and treating patients with suboptimal responses.

Multiple sclerosis (MS) is an immune-mediated neurologic disease in which acute inflammatory events early in the disease course contribute to subsequent neurologic disability. The early relapsing inflammatory phase is followed by a progressive degenerative phase in which the frequency of acute inflammatory attacks diminishes but progressive loss of neurologic function continues. Current immune therapies are most effective in suppressing the acute inflammatory events that characterize the earlier stages of disease. Optimal suppression of these inflammatory events is likely to have the best potential for delaying or preventing loss of axons and decline in neurologic function. In view of these considerations, and because MS is a heterogeneous disease and response to disease-modifying agents (DMA) varies across individuals, it is important to identify suboptimal responders as early as possible to allow therapeutic modification while the opportunity to avert future loss of function remains. At present, no criteria for identifying suboptimal responders have been validated. In January 2004, a group of neurologists from 16 MS centers in the United States met to develop a consensus on criteria for defining suboptimal response for use in compelling clinical situations and to prompt clinical studies to validate the efficacy of these criteria. Consensus criteria included relapse rates of either 1/year or unchanged from pretreatment rates, incomplete recovery from multiple attacks, evolution of polyregional neurologic involvement, recurrent brainstem or spinal cord lesions, and cumulative loss of neurologic function sufficient to disrupt daily activities. The panel then considered the use of mitoxantrone for patients with worsening MS and a suboptimal response to DMA therapy.

Clinical Trials as Topic↗