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Cancer and Clinical Trials by James L. Wade III, M.D.


Cancer is not just one disease, but an entire family of diseases which are all characterized by one quality: body cells grow out of control.  Because there are many different kinds of cells throughout the body, and any of these could turn cancerous (malignant), there are in turn many different kinds of cancer.  And, since each different kind of cancer has its own unique behavior, there are different types of treatments and approaches depending on the cancer type, its location, and it chemical and biologic features.  Over the last decade, there has been dramatic progress made in better understanding and treating many types of cancer, and this progress occurs because of clinical trials.


Cancer clinical trials are organized treatment plans, established by experts, to standardize and measure how well patients do with the latest treatments for most types of cancer.  By combining the outcomes of many patients from across the country, who have the same disease and who are treated the exact same way, experts can quickly determine what treatments work best.  Over the last decade, such programs have greatly improved the outcome of patients with many common types of cancer. 

In addition to increasing the survival from cancer, clinical trials have also shown doctors how to improve the quality of life of cancer patients and reduce the severity of the side effects of treatment.  Clinical trials have also demonstrated that some malignancies, such as breast or prostate cancer, can be prevented.



Cancer clinical trials are designed by a team of specialists who review the world's literature and write a protocol, or recipe, that incorporates the best care available.  Many times there may be two or more active treatments for a disease, and the clinical trial can answer the question about which treatment would be the best for a given patient.

Clinical trials often add new, promising medications into a standard treatment to try to improve a patient's outcome.  Once the study is written, it is reviewed by many other specialists to ensure that all possible precautions are taken to protect patients and to ensure that the study is designed correctly so that the results will be meaningful.  These specialists will commonly edit or change the protocol during this process, each time making it a better program.  After the protocol is completely written, it is then passed through an Institutional Review Board (IRB).  The IRB will make sure that the treatment is appropriate, that all of the risks are spelled out, that the potential outcome is worth the risks, and that the protocol is monitored in a way to ensure patient safety.  Only after the study is approved by the IRB can patients then be enrolled in the clinical trial.  (Note:  Throughout the life of the study, the IRB continues to monitor the study to ensure that patient's safety is kept foremost.)


Once a patient is enrolled, his or her care is managed by a team.  Not only does the patient have an oncology doctor, but the team also includes a clinical research specialist, an oncology pharmacist, and one or more layers of care oversight designed to make sure that the patient is treated exactly by the protocol.  During the trial, patients are carefully assessed for side effects as well as for how well the treatment worked in fighting the cancer.  Because of this meticulous attention to detail, patients on clinical trials often have better outcomes and fewer side effects compared to patients receiving a similar treatment "off-study." 


After the trial is completed, the results are then collated (gathered and compared).  Sometimes this takes several years, because a good, effective, treatment will help patients live many years.  After all of the results are in, the data is analyzed and placed into a manuscript or paper that is published in a medical journal.  Nowadays, with the Internet, important study results are immediately disseminated over the Internet at a speed much faster than it took just a few years ago (when doctors had to wait for the results to be published in a printed medical journal).  Once positive results are released, patients in a clinical trial are often the first to find out from their oncologist.  This newer, faster form of rapid feedback can speed up the implementation of cutting edge treatments almost immediately after they are discovered.

The last decade has brought us enormous advances in the understanding of and treatment for many types of cancer.  This benefit is due, in large part, to the partnership between patients and their cancer doctors in the clinical trials process.  Progress to reduce the cancer burden will continue for years to come as a direct result of patient participation in these important programs.




q     Decatur is a national leader in cancer research participation.

q     Cancer research has been performed locally since 1986.

q     Decatur was involved in research that helped develop the current standard treatments for breast, prostate, lung and colon cancers.

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