Remember Echo Therapeutics (ECTE), that wonderful little reverse-merger bio-dreck company formerly known as Sontra and so loved by Florida bucket shops, Uri Landesman and Mark Nordlicht? The firm issued a press release last week trumpeting yet another “successful clinical trial”. The headline reads (emphasis ours):
Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony® Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 Diabetes
Being a curious sort, your author decided to take a look at the details of the clinical trial. Not by reading press releases, but by actually looking up the study. But when is a ‘Clinical Trial’ not a clinical trial? When you cannot find it on Clinicaltrials.gov perhaps? A search of the Clinicaltrials.gov database, try it yourself here, yielded absolutely no hits (see here) for any studies sponsored by Echo Therapeutics (ECTE). Yet, the company cheerfully continues in its press release:
(Echo) today announced positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes. Echo also announced that it plans to conduct a study in critical care patients in the near term.
Quite tellingly, Echo uses the term “positive results” but does not once mention “statistically significant” results. Why? Read on…
Using over 2,600 Symphony tCGM glucose readings from the twenty (20) study subjects paired with reference blood glucose measurements,
A sample size of only 20 patients….first semester statistics anyone? For an 80% powered study and desired statistical significance, one should need at least 26 subjects, and likely far more (and if memory serves, central limit theorem would suggest 30 at a minimum). Which just might be why Abbott (ABT) is recruiting 32 subjects for one of its studies (see here). And why the other actual players in the Continuous Glucose Monitoring (“CGM”) business recruit far more subjects. For example, DexCom (DXCM) is recruiting 230 patients for one of its studies (see here) and Medtronic (MDT) is recruiting 150 in a study (see here), not to mention Roche (ROG VX) doing a study with 130 patients (see here).
Of course, it is much more likely that this most recent press release was just a way to gloss over the fact that the company just did another discounted stock plus warrants PIPE deal, see here, and that it has been over 13 months since Echo filed for 510(k) approval of its other product, the Prelude Skin Prep System, and over 10 months since ECTE management had expected marketing clearance from the FDA (read more here and here). Once again ECTE=Fail.
The current trials are feasibility trials that have no impact on the health of a patient and therefore I don’t believe are registered with ClinicalTrials.gov. the same is true with sample size/statistical significance. Following the ICU trial, there is a Pivotal trial, which should be more robust.
Clinical trials are registered expect “other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes”
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134034.htm
[Look carefully, plenty of Phase I and Phase II (non-pivotal) trials are registered in the database, and ALL studies should be properly designed from a statistical standpoint, or else how can one rely upon the data? The bigger issue is the hype-filled wording of the headline and the press release. The term “Clinical Trial” has a very specific meaning to investors, and a small “feasibility” study should be properly labeled as such, right in the headline. – Editor]
Remember, this is a Class I/II device with no risk to the patient’s health. Trials putting a patient at risk are registered, but I don’t think every medical device registers their clinical trail. I think you are splitting hairs and setting the bar higher than it needs to be. I can’t imagine that any company offering up a new blood pressure monitor has to register each trial. A waste of time and money. Also realize that although the population of individuals was small in these trials, the overall population data set was not. How many readings were performed?
[If the data is not correct, and is relied upon for insulin dosage the patient could be at serious risk. More importantly the real players in CGM, Roche, Medtronic, Abbott, etc all have done better designed and documented Phase I and II trials. Just go to the database and see for yourself. – Editor]
Symphony will be submitted for PMA certification.