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The Benefits of Clinical Trials

Clinical trials represent leading-edge medical science. However, less than 5% of adults diagnosed with cancer each year are enrolled in them. While there are a number of various treatment approaches being offered, 8/10 patients are not aware that this is a viable option for them. If they are offering treatment options above and beyond the standard treatment, why are patients not utilizing this valuable resource?

Results from surveys and focus groups concluded that the vast majority of patients are unaware of clinical trials and doctors are not enrolling patients due to a lack of time, staffing, funding, and resources. Indeed, enrolling a patient in a trial requires a significant amount of time and resources for physicians. Furthermore, there are some serious misconceptions held by some physicians and patients.

Molecular targeted clinical trials need to be viewed separately from other trials.

Since targeted trials are based on well-established molecular mechanisms, they do not require large-scale studies to produce relevant statistical data. This is an important distinction as the techniques used to identify the more general chemotherapy drugs currently being used, were based on applying the same drug to many patients with a particular form of cancer, and did not consider the genetic variation amongst the patients, their cancers, or diet. In the case of these generalized and less stratified trials, large numbers of patients were needed to produce relevant statistical data.

A common myth is that a patient may receive a placebo (control group) instead of the treatment being tested (single or double blind studies). However, clinical trials for cancer do not typically use this approach. There are two considerations regarding this point. Firstly, if a placebo or control group is used in a trial, it is almost always the standard treatment for that cancer that the patient would have otherwise used.

Secondly, most targeted clinical trials are open label and the patient has the choice of what role they perform. Furthermore, if the tested drug starts to show significant benefits, the control group is given the option to switch to the drug as it would be highly unethical to deny a patient with a specific genetic marker, effective treatment.

The use of molecular signatures in identifying optimal therapies has problems and benefits.

(1) Molecular targeted clinical trials require expensive and complex genetic profiling.

(2) Molecular targeted clinical trials provide a tool to address the heterogeneous nature of cancer and have far less side effects than general chemotherapy/RT.

While the numerous variations of therapeutic approaches combined with the complexity of navigating the copious clinical trials databases has proved a daunting task, this effort can be greatly mitigated by having a statistically determined molecular outline that allows the user to focus on finding trials based on pre-defined molecular variables (markers). Not only does this approach reduce the time and effort required, it allows for personalized treatments (better results with less side effects), reduces the patient burden for the doctor and medical system, and provides scientific data. Furthermore, even if the patient is not accepted in the trial, they are provided with important molecular data that can greatly improve further treatment efforts.

And finally, using multiple targeted clinical trials allows the patient to greatly reduce the overall genetic variation of their cancer, one trial at a time.

Alex Rolland is a cancer researcher, educator, and CEO of Cancer treatment Options and Management (CTOAM). CTOAM is a personalized cancer research company that specializes in using the most current peer reviewed scientific research on cancer diagnostics, treatments, nutraceuticals, and clinical trials to educate patients on the treatments and diets that provide the best statistical chances for success.


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