scholarly journals Quality Evaluation of the Clinical Trials for Natural Products Used in Cancer: An Evidence-Based Literature Review

2020 ◽  
Vol 10 (22) ◽  
pp. 7961
Author(s):  
Rizwan Ahmad ◽  
Lina Hussain AlLehaibi ◽  
Abdulrahman K. Alshammari ◽  
Saif M. Alkhaldi

The amount of data regarding the use of herbs/herbal products in cancer clinical trials at times creates a great challenge for oncologists to prescribe or counsel patients. It urges critical evaluation of the quality of clinical trials. Herein, for the first time, the clinical trials for herbs used in cancer were critically evaluated on the basis of three widely used scales, i.e., Jadad, Delphi, and Cochrane scales. The literature was collected with the help of online databases, journals, libraries, and books using a number of specific keywords as mentioned in detail in forthcoming sections. A total of 73 clinical trials were extracted, evaluated, and scored for 14 herbs, according to the predefined criteria mentioned below. A major deficiency of “non-blinding of clinical trials” was observed. The principal component analysis revealed four components (PC1–PC4) with a total variability of 68.21%, wherein the highest percentage variability was observed for PC1 loaded with “non-blinding of the clinical trials, no concealment of the treatment allocation, non-blindness of the patient and care provider”, which accounted for 30.81% of the total variability. The next major variability of 14.70% was observed for PC2 loaded with “non-randomization of the studies, non-blinding of the outcome assessors, no proper drop-out procedures, and lack of information regarding baseline characteristics for the groups”. Pearson’s correlation further confirmed a similar correlation pattern for the mentioned deficiencies (p = 0.05). An in-house grading scale was developed, showing a very small portion (16.44%), i.e., 12/73 studies with a good quality, whereas the majority (57.54%) of the studies, i.e., 42/73, were found to be of poor quality. The rules and regulations governing the quality of clinical trials needs to be more stringent and updated for the natural products/herbs used in cancer clinical trials.

2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.


2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 6584-6584
Author(s):  
Shanthi Sivendran ◽  
Kristina Braine Newport ◽  
Adam Albert ◽  
Matt D. Galsky

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e17652-e17652 ◽  
Author(s):  
Vikram Gota ◽  
Manjunath Nookala ◽  
Akanksha Yadav ◽  
Sadhna Kannan ◽  
Raghib Ali

The Lancet ◽  
2001 ◽  
Vol 358 (9295) ◽  
pp. 1772-1777 ◽  
Author(s):  
Steven Joffe ◽  
E Francis Cook ◽  
Paul D Cleary ◽  
Jeffrey W Clark ◽  
Jane C Weeks

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