scholarly journals Broadening Diversity in Alopecia Areata Clinical Trial Participants

2020 ◽  
Vol 20 (1) ◽  
pp. S78-S79
Author(s):  
Amy J. McMichael
Keyword(s):  
Clinical Trial ◽  
Alopecia Areata ◽  
Trial Participants

scholarly journals Assessing an Electronic Health Record research platform for identification of clinical trial participants

2021 ◽  
Vol 21 ◽  
pp. 100692
Author(s):  
Niina Laaksonen ◽  
Juha-Matti Varjonen ◽  
Minna Blomster ◽  
Antti Palomäki ◽  
Tuija Vasankari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Health Record ◽  
Research Platform ◽  
Electronic Health ◽  
Trial Participants

scholarly journals Current challenges and opportunities for pharmacogenomics: perspective of the Industry Pharmacogenomics Working Group (I-PWG)

2021 ◽  
Author(s):  
Karina Bienfait ◽  
Aparna Chhibber ◽  
Jean-Claude Marshall ◽  
Martin Armstrong ◽  
Charles Cox ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Group ◽  
Direct Sequencing ◽  
Risk Scores ◽  
Pharmaceutical Companies ◽  
Patient Privacy ◽  
Clinical Implementation ◽  
Genomic Databases ◽  
Group I ◽  
Trial Participants

AbstractPharmaceutical companies have increasingly utilized genomic data for the selection of drug targets and the development of precision medicine approaches. Most major pharmaceutical companies routinely collect DNA from clinical trial participants and conduct pharmacogenomic (PGx) studies. However, the implementation of PGx studies during clinical development presents a number of challenges. These challenges include adapting to a constantly changing global regulatory environment, challenges in study design and clinical implementation, and the increasing concerns over patient privacy. Advances in the field of genomics are also providing new opportunities for pharmaceutical companies, including the availability of large genomic databases linked to patient health information, the growing use of polygenic risk scores, and the direct sequencing of clinical trial participants. The Industry Pharmacogenomics Working Group (I-PWG) is an association of pharmaceutical companies actively working in the field of pharmacogenomics. This I-PWG perspective will provide an overview of the steps pharmaceutical companies are taking to address each of these challenges, and the approaches being taken to capitalize on emerging scientific opportunities.

scholarly journals Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

2002 ◽  
Vol 57 (2) ◽  
pp. 83-88 ◽  
Author(s):  
Edson Duarte Moreira ◽  
Ezra Susser
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Usual Method ◽  
Validity Of Results ◽  
Results Of Treatment ◽  
Trial Participants

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

scholarly journals Acceptability of Pulse-Fortified Foods by Two Groups: Participants in a Clinical Trial and Participants in a Consumer Acceptability Panel

Foods ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. 129 ◽  
Author(s):  
Donna Ryland ◽  
Peter Zahradka ◽  
Carla Taylor ◽  
Rhonda Bell ◽  
Michel Aliani
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Question ◽  
Health Benefit ◽  
Influential Factors ◽  
Consumer Acceptability ◽  
Fortified Foods ◽  
Overall Acceptability ◽  
Regular Consumption ◽  
Trial Participants

Pulses are nutrient-rich ingredients used as interventions in clinical trials to determine their effect on lowering blood lipids, which are risk factors for cardiovascular disease. Acceptability of these foods is critical for compliance by participants in clinical trials as well as regular consumption by those eating them for their health benefit. Commercialisation of foods that prove positive for health is required to make them available to the general population. Since the target for commercialisation would be products that will be procured by as many people as possible, the research question becomes whether or not testing is required by the clinical trial participants, by consumer acceptability testing in a sensory unit, or by both to ensure acceptability. The objective of this study was to determine the acceptability of pulse-based soups and casseroles destined for a clinical trial by both the participants in the clinical trial and by consumer participants not in the clinical trial. Neither group received any training regarding sensory analysis. Acceptability of aroma, appearance, flavor, texture, overall acceptability, and the frequency of eating the samples of five formulations fortified with either peas or beans was measured. Groups differed in their acceptability of foods for different attributes with the clinical trial participants providing less discrimination among the sensory attributes for their acceptability. Influential factors could include motivation for healthy eating, age, number of times the product was consumed, amount of the product consumed, and where it was consumed. In conclusion, acceptance measures from both groups are required in order to gain as much information as possible regarding acceptability of attributes for commercialisation of pulse-fortified foods that provide a health benefit.

scholarly journals Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

2018 ◽  
Vol 28 (1) ◽  
pp. 124-133 ◽  
Author(s):  
ARIELLA KELMAN ◽  
ANNA KANG ◽  
BRIAN CRAWFORD
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Research ◽  
Development Program ◽  
Well Being ◽  
Third Party ◽  
Clinical Development Program ◽  
Clinical Trial Evidence ◽  
Access To Medical Care ◽  
Trial Participants

Abstract:In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding continued access to investigational medicines in 2013. This article provides insights on the policy, including the parameters that determine when continued access is and is not considered to be appropriate, along with an example from an active clinical development program. It also describes how multiple stakeholders, including those in academia, industry, government, and patient advocacy, have worked together to assess approaches to continued access. Continued access plans should be transparent and agreed to by research participants, investigators, and governments prior to the study and reassessed based on clinical trial evidence of safety and efficacy and availability of adequate treatments, along with relevant international laws and customs. Conducting responsible continued access programs requires close partnerships with investigators, health authorities, and third-party research partners.

scholarly journals Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes

2020 ◽  
pp. molcanres.0751.2020
Author(s):  
Omar Alhalabi ◽  
Andrew W Hahn ◽  
Pavlos Msaouel ◽  
Alexander Y Andreev-Drakhlin ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Patient Outcomes ◽  
Early Phase ◽  
Molecular Profiling ◽  
Early Phase Clinical Trial ◽  
Metastatic Bladder Cancer ◽  
Phase Clinical Trial ◽  
Trial Participants

scholarly journals 0497 Rebound Insomnia During Discontinuation of Chronic Hypnotic Use

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A190-A190
Author(s):  
G Koshorek ◽  
J Verkler ◽  
T Roth ◽  
T Roehrs
Keyword(s):  
Clinical Trial ◽  
Sleep Latency ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Study Medication ◽  
Rebound Insomnia ◽  
Dsm V ◽  
Hypnotic Medication ◽  
Choice Period ◽  
Trial Participants

Abstract Introduction Rebound insomnia refers to worsened sleep relative to baseline on 1-2 nights after discontinuation of active hypnotic medication. Rebound is typically assessed using a placebo substitution. We assessed rebound in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication (i.e., no-pill) after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). On baseline and the14 discontinuation nights, sleep was recorded and scored by actigraphy for sleep efficiency (SE), sleep latency (LAT) and wake after sleep onset (WASO). Results Relative to the baseline night, on the first discontinuation night there was no difference in SE, LAT, and WASO. Fifteen subjects stopped taking study medication when told to discontinue and 16 subjects took study medication on one night or more. While not differing on baseline or night 1, on night 14 the last study night the medication users had a lower SE (75.9 vs 87.7 %, p<.0.004) and a longer LAT (61.5 vs 14.5 min, p<0.05). Conclusion Difficulty discontinuing hypnotic use is not specifically related to rebound insomnia. We reported in a companion abstract those with insomnia and hyperarousal, defined by MSLT, are those with difficulty discontinuing hypnotic use and as shown here slept poorly on the last study night. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

scholarly journals Response: Re: Has Demand for Clinical Trial Participants Outpaced Supply?

2007 ◽  
Vol 99 (12) ◽  
pp. 973-974
Author(s):  
J. Tam-McDevitt ◽  
L. Balducci ◽  
R. Hauser ◽  
S. Lichtman
Keyword(s):  
Clinical Trial ◽  
Trial Participants
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