While clinical trials represent leading cancer research, less than 5% of cancer patients enroll due to a lack of awareness and resources. Physicians have little time to enroll patients, and patients and doctors have misconceptions about clinical trials. Molecular targeted trials, based on genetic markers, require less patients than traditional trials to produce meaningful results. Unlike traditional trials, targeted trials do not use placebos and allow switching to tested drugs if beneficial. While complex genetic profiling is required for targeted trials, they provide more personalized treatment with fewer side effects than chemotherapy. Focusing clinical trial searches on predefined molecular markers can help patients find more suitable targeted trials.

1. 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 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.
The following link allows you to access clinical trials from over 174 countries!
http://clinicaltrials.gov/
Alex Rolland is a cancer researcher, educator, and CEO of Cancer treatment Options and
Management (www.CTOAM.com). 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.