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Biomedical subjects

James Witter

Publications and source records attributed to James Witter.

11 recordsLinked to original sources
PubMed2006

EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis.

OBJECTIVES: To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis. METHODS: An expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence-based and expert opinion-based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis. RESULTS: Based on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti-neutrophil cytoplasm antibody-associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis-specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research. CONCLUSIONS: On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well-designed research in non-AAV systemic vasculitides.

Antibodies↗
PubMed2005

Individual responder analyses for pain: does one pain scale fit all?

The outcomes of clinical trials are based on the mean responses of large numbers of subjects but fail to address inter-individual differences. The molecular mechanisms that underlie pain vary among individuals over time and among different types of pain to produce wide inter-individual variations in pain perception and response. Gender, ethnicity, temperament and genetic factors also contribute to individual variation in pain sensitivity and responses to analgesics. Pain measurement scales can be used differently across individuals based on the past pain experiences of individuals. We propose that individual responder analyses could be used in clinical trials to better detect analgesic activity across patient groups and within sub-groups, and to identify molecular-genetic mechanisms that contribute to individual variation.

Clinical Trials as Topic↗
PubMed2005

Fibromyalgia syndrome.

The objectives of the first OMERACT Fibromyalgia Syndrome (FM) Workshop were to identify and prioritize symptom domains that should be consistently evaluated in FM clinical trials, and to identify aspects of domains and outcome measures that should be part of a concerted research agenda of FM researchers. Such an effort will help standardize and improve the quality of outcomes research in FM. A principal assumption in this workshop has been that there exists a clinical syndrome, generally known as FM, characterized by chronic widespread pain typically associated with fatigue, sleep disturbance, mood disturbance, and other symptoms and signs, and considered to be related to central neuromodulatory dysregulation. FM can be diagnosed using 1990 American College of Rheumatology criteria. In preparation for the workshop a Delphi exercise involving 23 FM researchers was conducted to establish a preliminary prioritization of domains of inquiry. At the OMERACT meeting, the workshop included presentation of the Delphi results; a review of placebo-controlled trials of FM treatment, with a focus on the outcome measures used and their performance; a panel discussion of the key issues in FM trials, from both an investigator and regulatory agency perspective; and a voting process by the workshop attendees. The results of the workshop were presented in the plenary session on the final day of the meeting. A prioritized list of domains of FM to be investigated was thus developed, key issues and controversies in the field were debated, and consensus on a research agenda on outcome measure development was reached.

Delphi Technique↗
PubMed2004

What can chronic arthritis pain teach about developing new analgesic drugs?

Chronic pain remains an important public health need with greater impact on the US economy than most other chronic conditions. Current pain management is largely limited to opioids and non-steroidal anti-inflammatory drugs, indicating a gap in the translation of new knowledge to the development of improved pain treatments. Strategies suggested include the re-evaluation of current drug screening methods, a recognition that molecular-genetic events occurring acutely contribute to the development of pain chronicity, the validation of analgesic targets in the intended patient population, consideration of the unique genetic profile that varies between individuals, and the introduction of individual response measures to improve the capture of outcomes in clinical trials.

Acute Disease↗
PubMed2003

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

OBJECTIVE: To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. METHODS: Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. CONCLUSIONS: There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

Chronic Disease↗
PubMed2003

Chronic pain and fibromyalgia: the regulatory perspective.

Chronic pain is an important clinical entity that represents a currently unmet medical need. Relief of pain is an important public health goal for patients of all ages, from perinatal to geriatric. This article will describe some of the current regulatory issues in developing and approving drugs to treat chronic pain. It will also begin to familiarize the reader with the importance of the so-called 'label' and some of its roles to enable the best 'risk-benefit' decisions be made for, and by, patients with chronic pain.

Analgesics↗
PubMed2002

Drug development in rheumatoid arthritis.

In the United States, therapies to treat rheumatoid arthritis and juvenile rheumatoid arthritis are approved and regulated by the Food and Drug Administration. This article explores certain aspects of the current Food and Drug Administration guidance for drugs, devices, and biologic products intended to treat these diseases (in this article, the term "drug" refers to any therapy in rheumatoid arthritis). Newer therapeutics are targeting not only important molecular pathways but also new labeling claims intended to represent clinically relevant outcomes. Questions regarding whether the risks of these new therapies are balanced by their effectiveness will evolve. The process of improvement in clinical trial design and metrics, along with improved therapies, will undoubtedly present both familiar and new challenges in the future.

Antirheumatic Agents↗
PubMedDate not supplied

NIH-FDA Analgesic Drug Development Workshop: translating scientific advances into improved pain relief.

Analgesic drug development as currently undertaken is limited by a number of factors that contribute to the paucity of new analgesics introduced into clinical practice despite marked advances in delineating of the molecular-genetic mechanisms contributing to acute and chronic pain. The participants in this workshop explored the unmet need in analgesia and recommended strategies for enhancing analgesic drug development in the future. The workshop concluded that translating scientific advances into improved pain relief will require new thinking and a cooperative effort among the pharmaceutical industry, regulatory agencies, funding agencies, the biomedical research community, professional societies and clinicians. The workshop also recommended that a better understanding of the epidemiology of pain could contribute to improvement in clinical trial methodology and outcome measures.

Analgesics↗