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What Are The Requirements For Oncology Clinical Trials?


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By : jyoti sharma   9 or more times read
Submitted 2011-09-22 14:59:53

Simply put, clinical trials are medical research studies that are carried out by including patients whose conditions are relevant to the research. Oncology has become one of the biggest research fields in medicine, what with the increasing rates of cancer diagnosis worldwide. Though there is yet to be a definite cure for cancer, research has found methods of grappling with the condition that has even led to some patients going into remission. This would not be possible if patients did not avail themselves to the studies.

Objective of the study
For oncology clinical trials to begin there must first and foremost be a valid reason for the study to take place. For instance, there may be a new drug that needs to be tested on humans before it is sold. In such a case, a clinical trial may be conducted. This, however, is only done once the drug has been thoroughly tested on the lab and had positive results.

Sponsor
Clinical trials are costly, so there must be a sponsor that will bear the financial burden of the whole process. Sponsors may come in the form of governments, biotechnology companies or pharmaceutical companies. Sponsors will more often than not employ the services of a contract research organization which has the resources to carry out a clinical trial.

Recruitment
There must also be a recruitment process for the patients that will be involved in the research. The criteria for selection are predetermined, so that there is no partiality once contact with the patients has been made. Criteria may be made based on the age of the patients, the number of years that they have lived with cancer or even the kind of treatment they are taking. This of course, will really be determined by the nature of the research.

Protocol
A clinical trial protocol should also be prepared, which is a document that gives all the vital information regarding the study, including methodology and scientific rationale behind the study. In most countries where clinical trials are conducted, the clinical trial protocol must adhere to certain standardized practices as a means of regulation.

Beneficiaries
These are just some of the things that are required to be in place before cancer clinical trials take place. With the potential for success that each clinical trial promises, a lot of resources are dedicated to the same. At the end of the day, it is the patients who stand to gain the most as new cancer treatments are discovered.


Author Resource:- Oncology , Oncology Phase 1 studies


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