scholarly journals Proof of Concept to Clinical Confirmation: Evolving Clinical Trial Designs for Targeted Agents

ISRN Oncology ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-6
Author(s):  
Laura Finn ◽  
Winston Tan
Keyword(s):  
Clinical Trial ◽  
Personalized Medicine ◽  
Clinical Outcomes ◽  
Clinical Characteristics ◽  
Response To Therapy ◽  
Targeted Agents ◽  
Proof Of Concept ◽  
New Agents ◽  
Clinical Trial Designs ◽  
Tumor Types

No single therapy benefits the majority of patients in the practice of oncology as responses differ even among patients with similar tumor types. The variety of response to therapy witnessed while treating our patients supports the concept of personalized medicine using patients' genomic and biologic information and their clinical characteristics to make informed decisions about their treatment. Personalized medicine relies on identification and confirmation of biologic targets and development of agents to target them. These targeted agents tend to focus on subsets of patients and provide improved clinical outcomes. The continued success of personalized medicine will depend on the expedited development of new agents from proof of concept to confirmation of clinical efficacy.

Clinical trial designs for targeted agents

2002 ◽  
Vol 16 (5) ◽  
pp. 1287-1305 ◽  
Author(s):  
Brigette B.Y Ma ◽  
Carolyn D Britten ◽  
Lillian L Siu
Keyword(s):  
Clinical Trial ◽  
Targeted Agents ◽  
Clinical Trial Designs

scholarly journals Randomized Phase III Clinical Trial Designs for Targeted Agents

2008 ◽  
Vol 14 (14) ◽  
pp. 4358-4367 ◽  
Author(s):  
Antje Hoering ◽  
Mike LeBlanc ◽  
John J. Crowley
Keyword(s):  
Clinical Trial ◽  
Phase Iii ◽  
Targeted Agents ◽  
Phase Iii Clinical Trial ◽  
Clinical Trial Designs

Designing Transformative Clinical Trials in the Cancer Genome Era

2013 ◽  
Vol 31 (15) ◽  
pp. 1834-1841 ◽  
Author(s):  
Stefan Sleijfer ◽  
Jan Bogaerts ◽  
Lillian L. Siu
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Point Of Care ◽  
Growth Factor Receptor ◽  
Molecular Profiling ◽  
Cancer Genome ◽  
Histopathologic Diagnosis ◽  
Epidermal Growth ◽  
Clinical Trial Designs ◽  
Tumor Types

The incorporation of molecular profiling into routine clinical practice has already been adopted in some tumor types, such as human epidermal growth factor receptor 2 (HER2) testing in breast cancer and KRAS genotyping in colorectal cancer, providing a guide to treatment selection that is not afforded by histopathologic diagnosis alone. It is inevitable that over time, with rapid advances in scientific knowledge, bioinformatics, and technology to identify oncogenic drivers, molecular profiling will complement histopathologic data to influence management decisions. Emerging technologies such as multiplexed somatic mutation genotyping and massive parallel genomic sequencing have become increasingly feasible at point-of-care locations to classify cancers into molecular subsets. Because these molecular subsets may differ substantially between each other in terms of sensitivity or resistance to systemic agents, there is consensus that clinical trials should be more stratified for or be performed only in such molecularly defined subsets. This approach, however, poses challenges for clinical trial designs because smaller numbers of patients would be eligible for such trials, while the number of novel anticancer drugs warranting further clinical exploration is rapidly increasing. This article provides an overview of the emerging methodologic challenges in the cancer genome era and offers some potential solutions for transforming clinical trial designs so they can identify new active anticancer regimens in molecularly defined subgroups as efficiently as possible.

scholarly journals THU0566 THE EFFECT OF KINESIO-TAPING ON CHRONIC NONSPECIFIC LOW BACK PAIN: PRELIMINARY RESULTS OF A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 524.1-525
Author(s):  
I. Aachari ◽  
K. Samia ◽  
T. Latifa ◽  
T. Fatima Zahrae ◽  
S. Afilal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Placebo Group ◽  
Back Pain ◽  
Randomized Clinical Trial ◽  
Clinical Characteristics ◽  
Functional Disability ◽  
Low Back ◽  
Kinesio Taping ◽  
Secondary Outcomes

Background:The technique of Kinesio-Taping is a method of adhesive bandage exerting traction on the skin which would favorably influence the muscular and articular systems by reducing the pressure exerted on the subcutaneous mechanoreceptors thus reducing pain and muscle tension.Objectives:The aim of this study is to assess the effectiveness of Kinesio-Taping in the short and medium term on pain and function in patients with chronic nonspecific low back pain compared to a placebo.Methods:We conducted a double-blind, two-arm randomized clinical trial. The study should include a total of 70 patients randomized into 2 groups: Kinesio-Taping (n = 35) and control group (n = 35). To this date we have included 46 patients.All patients receives four I-shaped adhesive strips arranged in a star-like shape and applied to the most painful region of the lower back with a tension between 25% to 30% in the taping group. The placebo group received a taping procedure with no tension.Taping is applied three times (at baseline, fourth and eighth day). Patients are assessed at baseline, on day 14 and at 4 weeks by the Arabic version of the Oswestry Physical and Functional Disability Index (ODI) which is the primary outcome. The secondary outcomes are the assessment of pain and functional disability according to the visual analog scale (VAS) evaluated on a scale of 0 to 10, as well as Rolland-Morris score.Results:Both groups were comparable at baseline concerning the demographical and clinical characteristics (P > 0.05) (table 1). The result of repeated measures ANOVA showed a significant change in ODI score and in VAS for pain and functional disability as well as Rolland-Morris score in both groups. Using the ANCOVA, controlling for pre-test scores, a significant difference was found between the two groups (table 2).Table 1. Clinical characteristics of study population.Conclusion:Our clinical trial offers preliminary evidence on the superiority of Kinesio-Taping in the treatment chronic back pain compared to placebo concerning the reduction of pain and disability. Thus, it can be used as a complementary method in chronic non-specific low back pain.Table 2. Primary and secondary outcomes in the Kinesio-Taping and placebo group.Disclosure of Interests:None declared

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