Thursday, October 21, 2010

Research matters

With all the attention on clinical matters, it is easy to forget that a substantial portion of the role of academic medical centers is related to research. Here at BIDMC, over 1600 people are involved in research. These include principal investigators, other research faculty, fellows, technicians, and students. We have about 400 thousand square feet of research space under management, some owned by us and other leased.

The chart above shows our research activity in dollar terms over time, compared to the trend in NIH funding during the same period. In contrast to the highly competitive aspects of clinical care in the Boston market, there is a good amount of cooperation on the research front. Many projects are multi-institutional in nature.

One such program is the Dana Farber/Harvard Cancer Center, which brings together researchers from Dana Farber Cancer Institute, MGH, Brigham and Women's Hospital, Children's Hospital, BIDMC, Harvard Medical School, and the Harvard School of Public Health. Among other things, this program facilitates the availability of clinical trials of new cancer therapies to patients in the member hospitals.

Of course, we are properly expected to administer these trials in a way totally consistent with all rules and regulations. We recently concluded that we were not doing so with regard to some issues of documentation and reporting. Although there has been no indication that these mistakes had any impact on patients, we temporarily suspended enrollment until we can remedy the problems. As noted in this Boston Globe story by Liz Kowalczyk, we

. . . expect most of the trials to open to new patients within weeks — a half dozen already have — once investigators and support staff have completed additional training on compliance with trial rules and proper documentation of progress and results.

Fortunately, too, during this period, new patients will still have access to trials because of the multi-institutional aspect of the research program.

Hospital officials said about 25 cancer patients a month typically enroll in trials, and most who need access to experimental treatments before a trial reopens would be referred to another Harvard hospital that is part of the cancer center.

5 comments:

Barry Carol said...

I’m curious to know how much of your research budget is funded by NIH grants and how much relates to cancer research including clinical trials.

It seems that there is lots of potential for conflict of interest in cancer research. I wonder, for example, about the temptation among oncologists involved in cancer research to overstate the potential of an experimental drug to help a late stage cancer patient for whom established treatments were not successful. Have patients been fully informed regarding potential side effects and likely quality of life even if their lives are extended somewhat? To what extent are the patients’ stated wishes, if any, regarding end of life care taken into account?

Successful trials are exciting and rewarding and can advance the careers of academic researchers. Also, while the experimental drugs are provided at no cost to the patient, other medical costs (hospital, physicians, etc.), which are expensive, still need to be paid for by insurers and/or the patient and the family. Even when clinical trials are successful and lead to FDA approval for a new cancer treatment, the cost of a course of treatment is extremely high for often little more than a few weeks or months of low quality life. If there is an area of healthcare that should be subject to rigorous cost-benefit analysis, including QALY metrics, to determine what will be paid for and how much, it’s cancer treatment. Just my opinion, of course.

Paul Levy said...

66% of our research budget is from NIH and other federal agencies (mostly NIH). I'm not sure of the cancer percentage.

Your concerns are meant to be addressed through a very, very rigorous IRB review process, eligibility requirements, and the like. Others, more knowledgeable, can comment on the efficacy of those, but my impression is that they work well to address the issues you raise.

kosherfrog said...

Let me preface the following comment by stating clearly that I am a full supporter of CER and QALYs for many medical procedures and treatments of chronic diseases. That said, Barry Carol's comment sent shivers down my spine! QALY metrics for cancer trials?

CER and oncology are usually a very, very bad match! You cannot develop QALYs when the total population of patients suffering from a disease is small. And, as we learn a bit more every day, most cancer patients are suffering from a rare disease, one that may be with n=1.

Please do not try to push the tyranny of data in every direction, without fully understanding the most current science of medicine. Putting the future of oncology research in the hands of QALY experts may save lots of money but will cost many lives.

Following the recurring problems created by the NICE decisions in oncology, one cannot honestly ask to blindly implement QALY metrics in oncology.

Barry Carol said...

My earlier comment suggesting that cancer treatments should be subject to rigorous cost-benefit analysis and QALY metrics referred to FDA approved cancer drugs, NOT experimental drugs used in cancer trials. I have no problem with research driven cancer trials as long as doctors fully inform patients about likely side effects and respect the wishes of patients who might prefer to move into hospice or palliative care after their disease has reached a late stage and the prognosis is poor. My sense is that many times doctors hold out false help for patients with late stage, aggressive cancer because they are anxious to recruit them to enroll in drug trials.

Carrie Catanzaro said...

Just a brief comment from someone who works at a major research center in the midwest. Of course there is going to be the occasional researcher who is a touch overzealous in their patient recruitment activities, but effective human research protections training programs and ongoing educational opportunities go far to help alleviate this issue. Most researchers are ethical, and strive to perform research in the appropriate way, including working towards performing fully informed consent. Research coordinators also are highly participative in this process, and can be a great resource to ensure this is happening. Additionally, when working with patients the oncologist in charge of the patient's care should be addressing issues of palliative/hospice care - not necessarily the researcher/PI. Much could be done in this area outside of the research mileu; helping patients and families to understand the reasons for palliative care services - something that is sometimes a taboo topic. Mr. Levy's post regarding the actions taken in response to the recent issues is encouraging, as they indicate the organizations' willingness to address the issue openly.