MARINA DEL REY, Calif-Representatives of the American Association of Community Cancer Centers (ACCC), an organization of almost 500 cancer institutions, presented the group's Award for Outstanding Achievement in Clinical Research to Rodger J. Winn, MD, at their annual economics conference.
MARINA DEL REY, Calif-Representatives of the American Associationof Community Cancer Centers (ACCC), an organization of almost500 cancer institutions, presented the group's Award for OutstandingAchievement in Clinical Research to Rodger J. Winn, MD, at theirannual economics conference.
Dr. Winn, chief of the Community Oncology Program, Universityof Texas M.D. Anderson Cancer Center, is known for his outcomesresearch, particularly his analysis of the utilization of resourcesfor patients in the final months of their lives. He was instrumentalin establishing a research network for chemopreven-tion trialsthat includes many ACCC member institutions.
In his remarks following the presentation of the award, Dr. Winnoffered his perspective on what makes a good clinical researcher.They should be "obsessive, compulsive, and attentive to detail,"he said, but they must also be "cockeyed optimists,"always searching for that breakthrough treatment.
He spoke of attending a conference on the treatment of glioblastomaswith other cancer researchers. When conventional chemotherapy(which has not been very successful, he added) was discussed,he sensed a weariness among his colleagues. But when new neurochemicaltreatments, such as small molecules for tyrosine-kinase receptorsand protease inhibitors were introduced, the mood of the audiencechanged to one of excitement.
"Some of us think the 1980s were quiet, and that may be trueclinically; but on a basic science level, there was an explosion,and we're just beginning to reap the benefits of that. The biggestbenefit will be identifying those at risk for cancer much moreprecisely, so that preventive measures can be taken," henoted.
Clinical researchers also need to be flexible and able to changetheir beliefs when new information requires it. He described two"sacred cows" of clinical research that, in his opinion,need to be reevaluated.
The first "sacred cow" has already been proven false,Dr. Winn claimed. This belief was that "research had to bedone in elite academic centers, and not by community oncologists."Dr. Winn said that at least 30% to 40% of clinical research iscurrently done in communities. Furthermore, "every studythat's been done examining the quality of the data shows thatcommunity oncologists perform research equal in quality to thatof academicians."
Another "sacred cow" he targeted for reevaluation isthat "the best management of a cancer patient is a clinicalprotocol." Dr. Winn said that oncologists are beginning tothink that "maybe clinical protocols-the repetitive testing,the minutiae of visits-do not offer as good care as clinical practice."
Studies presented at the 1994 annual meeting of the American Societyof Clinical Oncology (ASCO) showed that in breast cancer and melanoma,the close follow-up performed in clinical trials may not be clinicallyimportant, he said.
For example, M.D. Anderson researchers are very aggressively treatingacute leukemia, performing bone marrow studies on patients every3 months for the first 2 years of treatment. However, when theycompared data from blood smears and bone marrow samples, in 85%of the cases that showed disease recurrence, tumor cells werepresent in the bone marrow and in the blood at the same time.
In the 12% to 13% of patients in whom disease was first foundin the marrow, it was present in the blood only 3 weeks later(which is not a clinically relevant difference, he said).
In clinical research, it is critical to make sure that the studyresults will answer the correct question. Many researchers, influencedby their biologic science training, try to answer the question-whatis happening to the tumor? So the relevant measurement, in thatcase, would be the response of the tumor to treatment.
In Dr. Winn's opinion, the question instead should be-what ishappening to the patient? Researchers would then focus on an entirelydifferent set of measurements: patient survival, quality of life,and patient satisfaction.
The variable of patient satisfaction is often used in marketingresearch and is therefore viewed by some as "soft science."Dr. Winn pointed out that when patient satisfaction is examinedat a very cursory level, many studies obtain such similar andpredictable results (eg, all hospital food is bad) that "wewonder why they are done at all."
"But in reality, patient satisfaction is a multidimensionalvariable and really does reflect the quality of care received,"he said. He divides patient satisfaction into four aspects orcomponents: amenities, interpersonal skills, access to the system,and technologic expertise. ( side bar shows how patients mightapply these components to evaluate their care in a specific situation.)
The effectiveness of a hospital's services, for example, its painmanagement practices, can be studied using patient satisfactionas a global measurement, Dr. Rodger Winn said in his talk at theACCC's annual economics conference (see story above).
When patients are asked if they were satisfied with the pain managementprovided by the hospital, Dr. Winn believes they will evaluatefour aspects of patient satisfaction-amenities, interpersonalskills, access to the system, and technologic expertise-as theyapply to pain management and combine these opinions to arriveat a single answer.
In evaluating the hospital's amenities, ramps, comfortable chairsand beds, and bars in the bathroom may have a positive affect.The interpersonal skills component would be impacted by the attitudesof the nurses and doctors, and their availability for answeringthe patient's questions.
A quick response by the staff when the patient needed additionalpain medication would positively affect the access aspect, Dr.Winn said.
And, he concluded, the technologic expertise component would begreatly affected by the success of the pain management treatmentsat alleviating the patient's distress.