Week 6- Aniqua Rahman

There wasn’t any new or interesting case in the clinic this week that I would like to mention here. In addition to clinic, I spent two days in ER and Medical ICU this week. I expected the ER to be busier than other areas, but it was kind of slow on my scheduled day. I was able to follow only one case, but couldn’t even follow it till the end because I had to leave the ER early to attend the weekly meeting.

Therefore, I decided to discuss something else for this week’s blog that I found very interesting in the past few weeks at WCMC. There is a brain cancer clinical study device called the NovoTTF-100A System (manufactured by Novocure), which is on Phase III clinical trial. This system is portable, powered with batteries or power outlets and involves placing electrodes on the patient's scalp to deliver low-intensity electrical fields to the tumor site. Patient has to wear it 22 hours a day, shave their heads and carry all the wires and batteries in a bag while mobile. Novocure is recruiting patients from all over the world to validate the efficacy of its device. The device has already been approved based on results of a single international clinical study of 237 patients with recurrent glioblastoma multiforme who were randomly assigned to either treatment with the new device or chemotherapy. But now they are trying to take a further step by trying to approve this device for newly occurring glioblastoma multiforme, for which they need 800 patients. They need to test their device on at least 800 patients to get approval from FDA. Weill Cornell Medical College is one of the centers, which is participating in this global study of recruiting patients. This device has been on the run for the past 7 years and there are still about 80 slots left for newly occurred glioblastoma patients. When a new patient with glioblastoma comes to Dr. Pannullo’s office, the Cornell clinical research coordinator comes and demonstrates the device to the patient and family.

In the past three years, Cornell hasn’t recruited any patients. Earlier from Cornell, there were only three patients recruited who were interested to participate in the study. This made me realize that it already takes a really long time and research work to design and build a new device and then additional time to go through the legal processes to test and bring it to the market. Only if we could come up with some ideas to legalize a new device faster, then we would have improved quality of many lives easily (even though I completely understand that different phases in clinical trial are just to assure the safety and efficacy of a new device, but there should be some alternative ways!)