Understanding Clinical Trials
Clearing the Air of Misconceptions
Should You Volunteer for a Clinical Trial?
Boston's Dana Farber Cancer Institute report that "Despite widespread belief that enrollment in clinical trials leads to improved outcomes in patients with cancer, there is insufficient data to conclude that such a trial effect exists." They continued to explain that participating in a clinical trial is mainly an altruistic act, something a cancer patient does "for improving treatment of future patients," not for enhancing his or her own chances of survival.
Patients Usually Misunderstand the Purpose
According to a recent survey [Lancet 2001;358:1772-77], Oncologists questioned 240 participants in treatment-related clinical trials. Half had either relapsed or progressive diseases and two-thirds had been told they had less than a ten percent chance of surviving five years. Most patients felt that they had read the informed consent form carefully and had received adequate explanations. Yet this survey found that patients enrolled in clinical trials at Boston's top cancer hospitals generally misunderstood the purpose and potential benefit of such trials.
Many Trials, Few Treatments
Research organizations are able to receive funding much more easily if they can demonstrate that they are “close to finding a cure” for this or that cancer. Therefore, there is always a push to start a clinical trial (as long as the treatment is patentable) even if the treatment does not perform all that well. Running a clinical trial makes it appear that the treatment is effective and only needs “a little more money” to bring it into maturity.
Unfavorable Results, Destroyed?
The pharmaceutical companies are not required by the FDA to reveal any unfavorable information regarding clinical trials or any testing of their medications. Investigations have shown that some treatments will have four or five studies run before the researchers can produce two sets of study results that are required to move forward through the FDA process. Meanwhile, the people involved with the studies which had poor results or showed dangerous side effects, are amazed that the treatment moves forward. Excellent website information here: http://alternativecancer.us/clinical.htm
Alternative Medicine Clinical Trials for Cancer Treatment
Although in the past few decades, conventional medical treatment has become increasingly effective against cancer, over the long term about half of all cancer patients either fail to respond to treatment or, after apparently successful initial results, experience a recurrence and ultimately die from metastatic or advanced disease.
Researchers working within medical schools and hospitals, at government agencies such as the National Cancer Institute (NCI), in private research facilities, and within the pharmaceutical and biotechnology industries are devoting a great deal of effort to finding better cancer treatments and confirming that they are better than the existing ones.
Most academic medical centers (medical schools and the hospitals and other facilities affiliated with them) and many providers of care to cancer patients participate in clinical cancer research that focuses on assessing the effects of new treatments, or known treatments used in new ways, on people with cancer. Some providers choose not to recruit their patients into clinical research studies, either in general or on a case-by-case basis, on the grounds that a sick person should not be subjected to an untested treatment or because they feel that the standard care they offer is superior. Other providers encourage their patients to participate in research on the grounds that the treatment otherwise available is less than ideal and that the experimental treatment has shown enough promise to justify the risk. Website source here: http://www.rosenthal.hs.columbia.edu/cancer/info/ctrials.html
Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
HOUSTON, TX - January, 13, 2009 – The Burzynski Research Institute, Inc. (BRI) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) that enables the company to move forward immediately with a pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma.
Antineoplaston therapy (ANP) uses a synthetic version of naturally occurring peptides and amino acid derivatives found in the human body to target and control cancer cells without destroying normal cells. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure and means that the design and planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval.
“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies,” said Stanislaw R. Burzynski, M.D., Ph.D. “The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.” http://www.burzynskiresearch.com/assets/PressRelease_01132009_BZYR.pdf
Visit the Burzynski Patient Group website for up to date testimonials: http://www.burzynskipatientgroup.org/index.php
Visit our Documentary Video Library to view The Burzynski Movie
Should You Volunteer for a Clinical Trial?
Boston's Dana Farber Cancer Institute report that "Despite widespread belief that enrollment in clinical trials leads to improved outcomes in patients with cancer, there is insufficient data to conclude that such a trial effect exists." They continued to explain that participating in a clinical trial is mainly an altruistic act, something a cancer patient does "for improving treatment of future patients," not for enhancing his or her own chances of survival.
Patients Usually Misunderstand the Purpose
According to a recent survey [Lancet 2001;358:1772-77], Oncologists questioned 240 participants in treatment-related clinical trials. Half had either relapsed or progressive diseases and two-thirds had been told they had less than a ten percent chance of surviving five years. Most patients felt that they had read the informed consent form carefully and had received adequate explanations. Yet this survey found that patients enrolled in clinical trials at Boston's top cancer hospitals generally misunderstood the purpose and potential benefit of such trials.
Many Trials, Few Treatments
Research organizations are able to receive funding much more easily if they can demonstrate that they are “close to finding a cure” for this or that cancer. Therefore, there is always a push to start a clinical trial (as long as the treatment is patentable) even if the treatment does not perform all that well. Running a clinical trial makes it appear that the treatment is effective and only needs “a little more money” to bring it into maturity.
Unfavorable Results, Destroyed?
The pharmaceutical companies are not required by the FDA to reveal any unfavorable information regarding clinical trials or any testing of their medications. Investigations have shown that some treatments will have four or five studies run before the researchers can produce two sets of study results that are required to move forward through the FDA process. Meanwhile, the people involved with the studies which had poor results or showed dangerous side effects, are amazed that the treatment moves forward. Excellent website information here: http://alternativecancer.us/clinical.htm
Alternative Medicine Clinical Trials for Cancer Treatment
Although in the past few decades, conventional medical treatment has become increasingly effective against cancer, over the long term about half of all cancer patients either fail to respond to treatment or, after apparently successful initial results, experience a recurrence and ultimately die from metastatic or advanced disease.
Researchers working within medical schools and hospitals, at government agencies such as the National Cancer Institute (NCI), in private research facilities, and within the pharmaceutical and biotechnology industries are devoting a great deal of effort to finding better cancer treatments and confirming that they are better than the existing ones.
Most academic medical centers (medical schools and the hospitals and other facilities affiliated with them) and many providers of care to cancer patients participate in clinical cancer research that focuses on assessing the effects of new treatments, or known treatments used in new ways, on people with cancer. Some providers choose not to recruit their patients into clinical research studies, either in general or on a case-by-case basis, on the grounds that a sick person should not be subjected to an untested treatment or because they feel that the standard care they offer is superior. Other providers encourage their patients to participate in research on the grounds that the treatment otherwise available is less than ideal and that the experimental treatment has shown enough promise to justify the risk. Website source here: http://www.rosenthal.hs.columbia.edu/cancer/info/ctrials.html
Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
HOUSTON, TX - January, 13, 2009 – The Burzynski Research Institute, Inc. (BRI) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) that enables the company to move forward immediately with a pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma.
Antineoplaston therapy (ANP) uses a synthetic version of naturally occurring peptides and amino acid derivatives found in the human body to target and control cancer cells without destroying normal cells. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure and means that the design and planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval.
“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies,” said Stanislaw R. Burzynski, M.D., Ph.D. “The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.” http://www.burzynskiresearch.com/assets/PressRelease_01132009_BZYR.pdf
Visit the Burzynski Patient Group website for up to date testimonials: http://www.burzynskipatientgroup.org/index.php
Visit our Documentary Video Library to view The Burzynski Movie
DISCLAIMER:
This website is for educational purposes only. It is not intended as a substitute for the diagnosis, treatment or advice of a qualified, licensed professional. This site offers medical data and informs about alternative medical options. No one should consider that this site represents the "practice of medicine." This site assumes no responsibility for how the material herein is used. Please note that this website is constantly updating its content and, therefore, some of the information may be dated. Also, be advised that the statements regarding alternative treatments for cancer have not been evaluated by the FDA.
