The New Drug In The Clinical Trial Shows Promising Results In Reducing Tumor Of Colon Cancer

The recent clinical trial conducted in United states at Mayo Clinic revealed the new drug to reduce the effects of colon cancer.  The physicians today run out of the medicine to treat the colon cancer. The standard chemotherapy which is widely in practice is no longer showing the effective results. The new medicine that has bumped out of the clinical trial is showing the promising results today. The drug regorafenib was tested in the phase III in the clinical trial conducted with the 760 patients showed the better result over the placebo participants. The new drug, regorafenib is a multi-kinase inhibitor, which has the effect of slowing cell proliferation and blood vessel growth and tempering a variety of biological pathways that are activated in tumors. The clinical trials findings say that the patients treated with the new drug showed 29 percent progress in the survival when compared to the patients treated with placebo.

Will New Approach Reduce The Side Effects Of Clinical Trials Before They Pass to Clinical Trial?

Drug formulation by the expert researchers is followed by clinical trial before it hits the market. The side effects of the drug are finding an easy way into the clinical trials due the existing practices and millions of dollars are being wasted due to the failures in the clinical trials. The newly formulated drugs are tested on the mice to know the side effects before they are passed into the clinical trials. As the functionality of the mice liver differs from that of humans, they react differently and the side effects are finding an easy way into humanized clinical trials. 

The new innovation broke the ice at this juncture. Effort from the expert researchers enabled them to send the human liver cells into the mice, therefore developing humanized mice which could react like humans when the drugs are experimented. The process requires number of mice to conduct the process which is again a challenge here. The idea to reduce the side effects in the drug before it passes to the clinical trial sounds very valuable. The idea would also sound practically good if the researchers can develop the capability of inducing hundreds and thousands of implants in mouse.

Side Effects in Drugs Passed On To Clinical Trials

Clinical trials are in place to study the efficiency and safety of the un approved drug.  Clinical trials are conducted investing millions of dollars. The outcome of the clinical trial will fit in the desired results only when the benefits provided by the new drug outweigh the risks from the new drug. To reduce the failure rate of the clinical trial that involves million dollar investment, the researchers found out a new approach to the find out the side effects in the drug formulation before it reaches the clinical trial process. The current practice that exists in the clinical trial process does not help much. The drugs are tested on the animals to trace out the side effects before passing them to the clinical trials. 

Animals react in a different way when compared to humans so; the side effects can make an easy way to clinical trials. When the medicines are sent for testing and FDA approval which do not compromise on the safety and efficiency, the clinical trial is a great failure.  

Electronic Data capture in the Clinical Trial

The constant quest for the pharmacy companies to develop new drugs biologist and products to market has created a stressful environment around these industries to meet the workflow deadlines. The companies now believe that progress of the clinical trial can quicken by integrating the advanced technology like electronic data processing EDC. For the clinical trials to adapt to the new technology, certain modifications become mandatory in the clinical trial process.  The process work flow of the clinical trial has to be redefined to adapt the technology, EDC. The functionalists of the three main groups in the clinical trial the Investigator site, clinical monitors and clinical data managers has to be redefined in order to utilize the benefits of EDC to full. These Electronic data capture based clinical trials offer operational and cost effective approaches in data entry management solutions, identify errors in the clinical trial data management and determine the status of the clinical trial data. Implementation of EDC in the clinical trial should be decided before the enrollment of the first patient in the clinical trial.

Standard Operating Procedures Decides The Protocol Feasibility Of The Clinical Research

Clinical research protocol is very important to run the clinical research successfully. The impact of the protocol on the clinical trial needs to be evaluated the test article, assess the potential impact on subjects and review the budget for the clinical research study. All these information should be documented to decide the feasibility of the clinical trial. It is known fact that time lines, process, and method of execution varies from the sponsor to sponsor. Though it is surprising, few documents do not even discuss the price feasibility and time bounds and the information about the informed consent. All this information has to be pooled from the sponsor to decide the protocol feasibility.

Another factor that is very important in deciding the protocol feasibility are  protocol current standard practice for treatment, ethical parameters,  compliance concerns and safety concerns are also important. Protocol feasibility of the clinical trial needs to take number of points into consideration, having the standard operating procedures in place will help you have the check list before you start accessing the feasibility of the clinical trial protocol.

Good Recruitment copy Grabs the Attention of Patients

Patient recruitment copy should be clear and concise to get them act. While drafting the patient recruitment copy, you should understand the patient visiting the clinical trial site is not a medico. The usage of the technical terms in the document should be reduced to the maximum. If you have to mention the jargon in the clinical trial recruitment copy, make sure you define them clearly. Make the sentence simple and easily understood. 

Online readers have least patience to read the extensive docs, so make sure the document is waffle free. Use short sentences and paragraphs to detail the information in the web site.

Approved HIV Vaccine is up For Human Clinical Trial

Here is the good news for HIV sufferers. Your generation is going to be free from the HIV attack if the FDA approved HIV vaccine pass through the human clinical trial. The new vaccine developed by the researchers at University of Western Ontario is ready for human clinical trial. What is expected from the new HIV vaccine?  I know this the doubt that stood straight in your brain right now. The new invented HIV vaccine is approved for clinical trials to use a whole HIV-1 virus, which has been both killed and genetically engineered, to activate immunity.

The vaccine is going to be successful like other vaccines of polio, rabies and influenza. No doubt, it is going to be a mile stone in the vaccine world of the medicine and is going to save the life of many by killing the virus before it triggers the action.