A New Approach to Revolutionize Clinical Trials


It may be the biggest thing in medicine in a long time. It’s not a new drug, or therapy or discovery. Instead it’s a new way of doing clinical trials which could have a dramatic effect, particularly on those diseases that get less attention.

Initially it is aimed at the deadliest brain cancer, glioblastoma multiforme, known as GBM. From diagnosis, it can kill in about six months.

Traditionally clinical trials test one drug or a therapy on a lot of patients, sometimes thousands, against a control group that is treated with a placebo, or not treated at all. Trials drag on for years.

The aim in clinical trials, which are certified by the Food and Drug Administration and reviewed by FDA-appointed panels of experts, is to make sure that a drug, medical device or procedure is safe and effective. This system costs a huge amount of money — hundreds of millions of dollars — and takes years. It produces no collateral knowledge; and it doesn’t alleviate the suffering.

Also, it’s an imperfect system. When a drug or medical device is certified for sale by the FDA, it may be less effective than the manufacturer claims, or not safe. Witness the recalls and lawsuits against drugs and medical devices — like the ones against Avandia, the diabetes drug, and transvaginal mesh.

This form of testing is totally inappropriate for virulent diseases, where the cohort being tested is unlikely to live long enough to find the results.

That stark truth has driven a global fraternity of specialists in brain cancer to set up a new concept in clinical trials. These doctors, neurosurgeons, neuro-oncologists, biostatians and genetic researchers are out to make trials a present-tense matter.

Members of this fraternity of researchers and clinicians come from around the globe with a heavy —> Read More