Bevacizumab proves to be a new treatment for nasopharyngeal carcinoma

Good news for the patients suffering from the advanced diseases of nasopharyngeal carcinoma. The results of the clinical trial say that Bevacizumab will be more effective in treating nasopharyngeal carcinoma. It may give the effective treatment by blocking the spread of the diseases to other parts of the body. The combination of the treatment in the clinical trial widely used anti-cancer drug bevacizumab with standard chemoradiation therapy helped to increase the survival period of the patients. 

After the treatment with the combination of bevacizumab, at 2 years, 91 percent of the patients were still alive when compared to the placebo treatment with the standard one. Bevacizumab treats nasopharyngeal carcinoma by blocking vascular endothelial growth factor related to poor prognosis in head and neck cancers that are expressed in two thirds of Nasopharyngeal carcinoma.

Clinical Trials Say that Rilonacept Significantly Reduces Gout Flares

Clinical trials are conducted in four different phases to decide the efficiency of the drug. Each stage of the clinical trial decides certain credentials of the drug before it runs into the market. The recent clinical trial running in Phase II shows positive results to treat the gout flares.  rilonacept, an inhibitor of the protein interleukin-1 (IL-1), significantly reduced acute gout flares that occur when initiating uric acid-lowering therapy. The results of the clinical trials in the phase II stated that rilonacept is well tolerated with no serious infections or treatment-related serious adverse events reported. Unlike the placebo group that suffers from 33 flares, the active participants suffered only 6 flares. After a clinical trial conducted for 12 weeks, only 15 percent of the active group suffered from the infection when compared to the placebo participants

Remote Monitoring Of The Clinical Trial Data Increases Its Efficiency

The increasing technology has spread the scope of the clinical trial globally. Numbers of clinical trials today are running in the developing countries. Monitoring the clinical trial in person has become a major challenge to FDA in these scenarios. The major focus of FDA in conducting the monitoring in person is to protect human subjects, while maintaining data integrity and compliance with regulations. Evaluating the study conduct of the clinical trial with the frequent visits to the clinical trial remained as a predominant method in the clinical trial. To cut the travel expenses and time span, FDA now encourages onsite monitoring of the clinical trial data at the regular intervals. 

Most of the government sites are still not using centralized monitoring effectively; they still visit the clinical site once in two or three years to certify the safety of the clinical trial.  FDA urges the use of remote monitoring to ensure 100 percent safety of the clinical trial data. Using onsite remote monitoring fraud and fabrication, may be more readily detected says FDA. In spite of relying on the centralized monitoring of the clinical trial data, one should prefer on-site mentoring at least once in the early stages of the clinical trial.

FDA Rules For Safety Of Clinical Trial Data

Safety information about the clinical trial data in FDA reporting embeds new information from now. The changed rules of FDA insist in inclusion of some crucial information in clinical trial data reporting.

• Information regarding significant risks that affect the study participants should be disclosed in the clinical trial data reporting.
• Higher rate of adverse reactions than the expected should be notified in the clinical trial
• The information regarding the bioavailability studies that determine the amount of drug absorbed by the blood should be notified.
•  Any small reason that believed to be caused by the drug in the clinical trial has to be notified.

FDA also brings the revisions in the reporting standards to help ensure harmonized reporting of globally conducted clinical trials.

Skewed Clinical Trial Data To Manufacture Good Results

Good results from the clinical trial have become an ultimate motive of the pharmaceutical companies. They do not even bother about actual effects to the human beings from using the drugs manufactured by them. They try to hide some information like death of the subject during the trials and present only the positive outcome of the clinical trial in the final report. But the negative end of the clinical trials will be pulled out from the results in spite of using the best tactics to cover the negative effects. The clinical trial sponsor should stop hiding the negative effects of the clinical trial to make the drug enter the market. Ineffective drugs will not have their sustainability in the market for long time. Neither the end user nor the sponsor will benefit from them. It is just pouring millions of dollars into a pit and nothing else.