Value of Clinical Trials
Posted 3/17/2011
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I have written a number of times before about clinical trials--both about their design and function as well as their immense value. The value is not always evident or relevant for a single participant, but is always there in terms of gathering data and influencing future practice. Everything we know about treating cancer, or other diseases, is due to men and women who agreed to participate in clinical trials. One advantage of receiving care at a cancer center, larger hospital, or affiliated practice can be the availability of clinical trials. In cancer care, trials are never designed with a placebo arm, so the options are always standard care or something that might be even better.
When I was diagnosed with my first breast cancer in 1993, I participated in a clinical trial that examined the value of concurrent radiation and chemotherapy. That meant that I received the first cycle of chemotherapy, began radiation a week or so later, and continued with both through the six weeks of radiation. Once that was over, the chemotherapy went on for the prescribed total of six months. It was tiring during the weeks of both, and the skin burning was somewhat worse, but it was manageable, and it had the personal advantage of finishing everything a bit sooner. Frankly, I don't know what the results of that trial showed (and this is a big personal complaint about clinical trials in general: I think that all participants should be offered the results), but that schedule has never become the standard of care so I am guessing it didn't turn out to make a difference.
At any rate, this is a summary from Oncology Stat about the better survival of women who have their surgery with trained oncology/breast surgeons rather than general surgeons. The key difference seems to be participation in clinical trials and the attention that brings. Here is the introduction and a link:
Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
SAN ANTONIO (EGMN) - The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.
What's driving the improved outcomes isn't entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.
Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).
Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).
Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).
http://tinyurl.com/4tkngnp
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