Assessing the Onset of Relief of a Treatment for Migraine

Cephalalgia ◽  
2000 ◽  
Vol 20 (8) ◽  
pp. 724-731 ◽  
Author(s):  
EM Laska ◽  
C Siegel
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conceptual Framework ◽  
Active Treatment ◽  
Clinical Characteristics ◽  
Survival Distribution ◽  
Using Data

It is common for clinical trials designed to compare treatments for migraine to incorporate a component for estimating onset. Our objective is to describe a stopwatch method for collecting data on time to meaningful relief and a conceptual framework for describing and analysing the results. The survival distribution of onset is modelled in two parts: the probability that onset does not occur, and the survival distribution conditional on its occurrence. Using data from a clinical trial comparing an active treatment and placebo, we illustrate the method and find that the distributions of onset among those with onset do not differ, but the probabilities that onset occurs are substantially different. We illustrate how the model can be used to help determine how long patients without onset should wait before further intervention, how patients interpret the phrase meaningful relief, and how baseline clinical characteristics affect the onset.

scholarly journals Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Neha M. Jain ◽  
Alison Culley ◽  
Teresa Knoop ◽  
Christine Micheel ◽  
Travis Osterman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knowledge Representation ◽  
Conceptual Framework ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Prospective Clinical Trial ◽  
Future Trends ◽  
Current State ◽  
Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

Culturally Imprinted Anxiety and the Itinerary of Clinical Trial Projects for Its Management

2020 ◽  
pp. 106939712096730
Author(s):  
Tariq H. Malik
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cultural Theory ◽  
Uncertainty Avoidance ◽  
Anxiety Management ◽  
Moderation Effect ◽  
Confounding Variables ◽  
Management Project ◽  
Using Data

Anxiety has become ubiquitous in modern life, across countries. Cultural theories suggest that high uncertainty avoidance (UA) increases anxiety, while long-term orientation (LTO) decreases it. We question whether a high UA culture in a region attracts research and development (R&D) projects regarding anxiety management, compared to LTO. Furthermore, do these opposite dimensions moderate each other in attracting a pharmaceutical firm’s response? This article explores this link between the UA culture and the moderation effect of LTO. Using data on clinical trials related to anxiety management projects in 67 countries, we record 10,585 observations, capturing 4% of the global population of clinical trials on the subject. We find that the uncertainty avoidance index (UAI) shows a negative correlation with the intensity of the anxiety management project, while LTO has no significant correlation. The interaction between the two shows positive correlation. The results are found to be significant after controlling for confounding variables and robustness checks. This study makes three contributions. First, it highlights the link between culture and anxiety management projects through the clinical trial movement. Second, it contributes to cultural theory, suggesting that the UAI defines problems and LTO defines innovative solutions. It also highlights the differences and links between the UAI and LTO at the conceptual level. Thirdly, it offers general policy and practical implications.

Strategies for research participant engagement: A synthetic review and conceptual framework

2021 ◽  
pp. 174077452110110
Author(s):  
Charlene A Wong ◽  
William B Song ◽  
Megan Jiao ◽  
Emily O’Brien ◽  
Peter Ubel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conceptual Framework ◽  
Research Participant ◽  
Behavioral Strategies ◽  
Participant Recruitment ◽  
Recruitment And Retention ◽  
Participant Engagement ◽  
Cochrane Reviews ◽  
Changing Attitudes

Background: Research participant engagement, which we define as recruitment and retention in clinical trials, is a costly and challenging issue in clinical research. Research teams have leveraged a variety of strategies to increase research participant engagement in clinical trials, although a framework and evidence for effective participant engagement strategies are lacking. We (1) developed a novel conceptual framework for strategies used to recruit and retain participants in clinical trials based on their underlying behavioral principles and (2) categorized empirically tested recruitment and retention strategies in this novel framework. Methods: We conducted a synthetic analysis of interventions tested in studies from two Cochrane reviews on clinical trial recruitment and retention, which included studies from 1986 to 2015. We developed a conceptual framework of behavioral strategies for increasing research participant engagement using deductive and inductive approaches with the studies included in the Cochrane reviews. Reviewed interventions were then categorized using this framework. We examined the results of reviewed interventions and categorized the effects on clinical trial recruitment and retention as significantly positive, null, or significantly negative; summary statistics are presented for the frequency and effects of each behavioral strategy type. Results: We analyzed 141 unique interventions across 96 studies: 91 interventions targeted clinical trial research participant recruitment and 50 targeted retention. Our framework included 14 behavioral strategies to improve research participant engagement grouped into four general approaches: changing attitudes by appealing to social motivators, changing attitudes by targeting individual psychology, reducing barriers and cognitive burdens, and providing incentives. The majority of interventions (54%) aimed to reduce barriers or cognitive burdens, with improving comprehension (27%) as the most common specific strategy identified. For recruitment, the most common behavioral strategies tested were building legitimacy or trust (38%) and framing risks and benefits (32%), while financial or material incentives (32%) and reducing financial, time, and social barriers (32%) were most common for retention interventions. Among interventions tested in randomized controlled trials, 51% had a null effect on research participant engagement, and 30% had a statistically significant positive effect. Discussion: Clinical researchers have tested a wide range of interventions that leverage distinct behavioral strategies to achieve improved research participant recruitment and retention. Common behavioral strategies include building legitimacy or trust between research teams and participants, as well as improving participant comprehension of trial objectives and procedures. The high frequency of null effects among tested interventions suggests challenges in selecting the optimal interventions for increasing research participant engagement, although the proposed behavioral strategy categories can serve as a conceptual framework for developing and testing future interventions.

Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial

Cephalalgia ◽  
2021 ◽  
pp. 033310242110335
Author(s):  
Brooke L Reidy ◽  
James Peugh ◽  
Andrew D Hershey ◽  
Christopher S Coffey ◽  
Leigh A Chamberlin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Response ◽  
Active Treatment ◽  
Behavioral Therapy ◽  
Headache Frequency ◽  
Migraine Prevention ◽  
Prevention Study ◽  
Treatment Models ◽  
Daily Headache

Objective Identify preventive medication treatment response trajectories among youth participating in the Childhood and Adolescent Migraine Prevention study. Methods Data were evaluated from 328 youth (ages 8–17). Childhood and Adolescent Migraine Prevention study participants completed headache diaries during a 28-day baseline period and a 168-day active treatment period during which youth took amitriptyline, topiramate, or placebo. Daily headache occurrence trajectories were established across baseline and active treatment periods using longitudinal hierarchical linear modeling. We tested potential treatment group differences. We also compared final models to trajectory findings from a clinical trial of cognitive behavioral therapy plus amitriptyline for youth with chronic migraine to test for reproducibility. Results Daily headache occurrence showed stability across baseline. Active treatment models revealed decreases in headache frequency that were most notable early in the trial period. Baseline and active treatment models did not differ by treatment group and replicated trajectory cognitive behavioral therapy plus amitriptyline trial findings. Conclusions Replicating headache frequency trajectories across clinical trials provides strong evidence that youth can improve quickly. Given no effect for medication, we need to better understand what drives this clinically meaningful improvement. Results also suggest an expected trajectory of treatment response for use in designing and determining endpoints for future clinical trials. Trial Registration. ClinicalTrials.gov Identifier: NCT01581281

Overall survival of men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy according to their participation (or not) in clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 148-148
Author(s):  
Jatinder Goyal ◽  
Peng Huang ◽  
Prachi Tyagi ◽  
Daniel Oh ◽  
Michael Anthony Carducci ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Characteristics ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
First Line ◽  
Trial Participants ◽  
Baseline Hemoglobin

148 Background: There is insufficient evidence to determine whether clinical trial participation can itself lead to improved clinical outcomes in patients with mCRPC treated with docetaxel chemotherapy. We compared clinical characteristics and survival outcomes of patients with mCRPC receiving first-line docetaxel-containing therapy on a clinical study (trial participants) or outside of a clinical trial (non-participants). Methods: We retrospectively reviewed the records of 245 consecutive chemotherapy-naïve patients with mCRPC who received docetaxel-containing therapy between 1/1/1998 and 1/1/2010, either as trial participants (n=142; 11 separate studies) or as non-participants (n=103). Patient demographics, baseline clinical characteristics, treatment details and follow-up data were recorded. Results: In unadjusted analysis, trial participants were more likely to be white (83 vs 70%, p=0.005), to have better ECOG performance status (p=0.01), higher baseline hemoglobin (12.4 vs 11.6 g/dL, p=0.0003), higher albumin (4.3 vs 4.0 g/dL, p=0.009), lower creatinine (0.90 vs 1.04 mg/dL, p=0.01), and to have received a higher number of chemotherapy cycles (6.6 vs 5.1, p=0.001) than non-participants. In Kaplan-Meier analysis, median overall survival was significantly longer among trial participants vs non-participants (21.3 vs 17.1 months, p=0.024). In multivariable analysis, trial participation (HR 0.53, p=0.013), more chemotherapy cycles (HR 0.87; p=0.0002), baseline hemoglobin >12 g/dL (HR 0.67, p=0.016), lower ECOG score (HR 0.57, p=0.026) and lower baseline (log) PSA (HR 0.85, p=0.012) were all found to be independent predictors of survival. Conclusions: Clinical trial participation is an independent positive predictor of overall survival in men undergoing first-line docetaxel-containing chemotherapy for mCRPC. Improved survival in trial participants may reflect better medical oversight typically seen in patients enrolled in clinical trials, more regimented follow-up schedules, or a positive effect on caregivers’ attitudes due to greater contact with medical services.

Severe Gemcitabine-Associated Lung Injury in Hodgkins Disease & Other Cancers: Reporting Quality and Clinical Characteristics of Cases Reported in the Medical Literature and to the FDA.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3145-3145 ◽  
Author(s):  
Steven M. Belknap ◽  
Nicolas Slimack ◽  
Timothy Kuzel ◽  
Kenneth R. Carson ◽  
Paul R. Yarnold ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Lung Injury ◽  
Combination Chemotherapy ◽  
Clinical Characteristics ◽  
Case Reports ◽  
Reporting Quality ◽  
Trial Setting

Abstract Background: In view of concern about substantially increased risk of gemcitabine-associated lung injury (ALI), vigilant post-marketing surveillance is necessary to further characterize the frequency, severity, and clinical features of gemcitabine-associated pulmonary injury. Methods: From 2001–2003, investigators with the Research on Adverse Drug reactions And Reports (RADAR) program compared the clinical characteristics and adverse event reporting quality of gemcitabine-associated lung injury contained in published case reports and adverse event reports submitted in the setting of clinical trials or the non-clinical trial setting. Results: Completeness of reporting was excellent for published case reports and intermediate to poor for FDA adverse event reports from clinical trials or observational studies, including age (100%, 92%, 91%); time to onset of toxicity (100%, 63%, 58%); dose (97%, 63%, 79%); results of imaging studies (94%, 56%, 59%); presence/absence of hypoxia (97%, 6%, 4%); and cause of death (88%, 82%, 66%). Temporal analyses identified a bimodal pattern for the onset of pulmonary symptoms: 90% occurred before 150 days and 8% after 300 days. The highest rates of severe lung injury were in high dose patients co-administered bleomycin (28%) and in lung cancer patients (16%). Conclusions: Reporting completeness for severe gemcitabine-ALI to the FDA from the clinical trial and the non-clinical trial setting is poor, limiting the ability of the RADAR group to comprehensively assess this toxicity. Nonetheless, this toxicity is severe and, as shown in published case reports, frequent in the presence of concomitant pulmonary insults such as bleomycin-containing combination chemotherapy regimens for Hodgkin’s disease and taxol-containig combination chemotherapy regimens for lung cancer. Gemcitabine-associated Acute Lung Injury in Selected Clinical Trials Author DX Other ChemoRx N ALI % Friedberg JW Hodgkin Doxorubicin, Bleomycin, Vinblastine 12 5 42 Bredenfeld H Hodgkin BA_COPP 27 6 22 Chen YM Non-SCLC Vinorelbine 20 5 25 Popa IE Non-SCLC Docetaxel 32 6 19 Herbst RS Non-SCLC Vinorelbine 36 5 14 Blackstock AW Non-SCLC 16 2 13 Bhatia S Non-SCLC Paclitaxel 34 4 12 Safran H Pancr. Ca Paclitaxel, Radiation 19 2 11 Lobo F Breast Ca Vinorelbine, Anthracyclines 21 2 10

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

Sign in / Sign up

Export Citation Format

Share Document