scholarly journals Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial

Cancer ◽  
2017 ◽  
Vol 124 (3) ◽  
pp. 546-554 ◽  
Author(s):  
Becky Kinkead ◽  
Pamela J. Schettler ◽  
Erika R. Larson ◽  
Dedric Carroll ◽  
Margaret Sharenko ◽  
...  
Keyword(s):  
Early Phase ◽  
Massage Therapy ◽  
Cancer Related Fatigue ◽  
Early Phase Trial ◽  
Phase Trial

scholarly journals Evaluation of an Educational Program to Improve Communication with Patients About Early‐Phase Trial Participation

2012 ◽  
Vol 17 (3) ◽  
pp. 377-383 ◽  
Author(s):  
Lesley J. Fallowfield ◽  
Ivonne Solis‐Trapala ◽  
Valerie A. Jenkins
Keyword(s):  
Early Phase ◽  
Educational Program ◽  
Trial Participation ◽  
Early Phase Trial ◽  
Phase Trial

scholarly journals 201 Targeting tropomyosin receptor kinase (TRK) in CYLD defective tumours: A placebo-controlled early phase trial with pegcantratinib

2017 ◽  
Vol 137 (10) ◽  
pp. S227
Author(s):  
M. Danilenko ◽  
E. Stamp ◽  
D. Stocken ◽  
A. Cranston ◽  
R. Plummer ◽  
...  
Keyword(s):  
Early Phase ◽  
Receptor Kinase ◽  
Early Phase Trial ◽  
Phase Trial

Evolving Early Phase Trial Designs

2018 ◽  
pp. 33-46
Author(s):  
Marc R. Theoret ◽  
Lee Pai-Scherf ◽  
Christy Osgood ◽  
Abhilasha Nair ◽  
Patricia Keegan
Keyword(s):  
Early Phase ◽  
Early Phase Trial ◽  
Phase Trial

scholarly journals Early phase trial design for assessing several dose levels for toxicity and efficacy for targeted agents

2013 ◽  
Vol 10 (3) ◽  
pp. 422-429 ◽  
Author(s):  
Antje Hoering ◽  
Alan Mitchell ◽  
Michael LeBlanc ◽  
John Crowley
Keyword(s):  
Early Phase ◽  
Trial Design ◽  
Targeted Agents ◽  
Early Phase Trial ◽  
Dose Levels ◽  
Phase Trial

scholarly journals Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-Blind, Placebo-Controlled, Early Phase Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Dietlind L. Wahner-Roedler ◽  
Jeffrey M. Thompson ◽  
Connie A. Luedtke ◽  
Susan M. King ◽  
Stephen S. Cha ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Program ◽  
Early Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Early Phase Trial ◽  
Intent To Treat ◽  
Separation Test ◽  
Treat Analysis ◽  
Phase Trial

Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P= .02) and by 18% in the placebo group (P< .001). The difference in change in scores between the groups was not significant (P= .16). With the same analysis, CES-D scores decreased in the soy group by 16% (P= .004) and in the placebo group by 15% (P= .05). The change in scores was similar in the groups (P= .83). Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control) shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated.

scholarly journals Experiences of establishing an academic early phase clinical trials unit

2017 ◽  
Vol 14 (4) ◽  
pp. 349-356 ◽  
Author(s):  
Sarah R Brown ◽  
Debbie Sherratt ◽  
Gill Booth ◽  
Julia Brown ◽  
Fiona Collinson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Late Phase ◽  
Knowledge Retention ◽  
Lessons Learned ◽  
Phase Iii ◽  
Trial Management ◽  
Early Phase Trials ◽  
Early Phase Trial ◽  
Phase Trial

Background: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences. Methods: In 2009, the University of Leeds Clinical Trials Research Unit became the Clinical Trials Coordinating Office for Myeloma UK’s phase I and II trials. We embarked on a transition from working extensively in phase III to early phase trials development and conduct. This involved evaluating and revising our well-established standard operating procedures, visiting other academic early phase units, and developing essential new documentation and processes. Results: A core team of trial and data managers and statisticians was established to facilitate expertise and knowledge retention. A detailed training plan was implemented focussing on essential standard practices for early phase. These included pharmacovigilance, recruitment, trial design and set-up, data and site monitoring, and oversight committees. Training in statistical methods for early phase trials was incorporated. Conclusion: Initial scoping of early phase trial management and conduct was essential in establishing this early phase portfolio. Many of the processes developed were successful. However, regular review and evaluation were implemented to enable changes and ensure efficiencies. It is recommended that others embarking on this venture build on the experiences described in this article.

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