Thursday, August 16, 2007

The Difficulty of Managing Clinical Research

We are offering clinical research for our patients. It is no easy task. The mounds of paperwork required by the multitude of agencies involved is unbelievable. It is even more than I imagined and I knew it was bad. I'm amazed that so many centers offer it as part of their programs. Here is a small example of what we faced when starting our program. Agency 1 will not approve you for x until Agency 2 approves you for y. While at the same time, Agency 2 won't approve you for y until Agency 1 approves you for x. I joke with our Clinical Research Coordinator when she gets frustrated with the red tape that she is like one of those show dogs who jumps through all the hoops except there never is an end. Below is a list of several of the agencies whose requirements and regulations we have to meet to offer clinical trials.

  • FDA - Food and Drug Association
  • NIH - National Institutes of Health
  • NCI - National Cancer Institute
  • CTSU - Clinical Trials Support Unit
  • OHRP - Office of Human Research Protections
  • RPC - Radiological Physics Center
  • ITC - Image Guided Therapy QA Center
  • CTEP - Cancer Therapy Evaluation Program
  • QARC- Quality Assurance Review Center
  • NSABP - National Surgical Adjuvant Project for Breast & Bowel Cancer
  • RTOG - Radiation Therapy Oncology Group
  • ECOG - Eastern Cooperative Oncology Group
  • SWOG - Southwest Oncology Group
  • GOG - Gynecologic Oncology Group

There are many more. We have a legal agreement with each of these organizations and thus have to send them through the legal department for review which can take a considerable amount of time. And I haven't even mentioned what it takes to get a protocol approved through yet another acronym, the

  • IRB - Institutional Review Board

Another problem we have is recruiting enough patients to go on trial. Patients like the idea of clinical trials but they don't like the idea of possibly receiving a placebo. I wouldn't either. Thus many opt for traditional treatment until there are no other options. Many by then don't have the will, the energy, or the qualifications to go on a clinical trial.

If you're looking for a clinical trial a great website is


You can search by drug, diagnosis, or just about any other thing you can think of. The only problem is it is hard to navigate or understand if you don't have much of a medical background. But by the time an individual or family member has resorted to searching for clinical trials they usually know enough to point themselves in the right direction.

Now, don't get me wrong. Clinical Trials are a great thing. They should just be a lot easier to offer and manage especially with the continued declining reimbursement environment we are facing every year.


Bayman said...

With all the administrative barriers are you able to run academic trials, or does this mean you always require private sect-scale funding?

Joe said...

We do our best to offer both. Half pharmaceutical and half cooperative group. This way we get some of the higher paying pharmaceutical trials to help cover the costs.