Information Mediary Corp

It is widely accepted that patients participating in clinical trials are less than perfectly compliant with their medication regimens. The extent to which non-compliance affects the results of clinical trials is unknown. Several factors mitigate against the assessment of this phenomenon, principal of which is the lack of a methodology to monitor patient compliance in a non-invasive way.

The problem of clinical trials involving patient-determined dosing is widely recognized. If data obtained in clinical trials where patients take medication once or twice a day are known to be inaccurate, it follows that data from patients taking medication intermittently over longer intervals will be even less accurate.

Pharmacotherapy may be viewed in terms of a signal to noise ratio (S/N).

In administering any medication, the aim is to maximize the S/N. The signal is the desired clinical effect; the noise comprises a multitude of factors that interfere with, or obscure, the clinical effect.

The clinical effect might be reduction in pain, control of seizures, reduction in white cell count, etc. Most of the myriad noise factors come under the category of 'individual differences' in response to medication. Gastrointestinal differences ranging from mal-absorption to eating habits, differences in metabolism, concomitant use of alcohol and street drugs, body mass, level of activity, use of herbal remedies, and many other noise factors conspire to obscure the therapeutic effect (signal).

Clinical trial costs are spiraling out of control. Recently completed studies have pegged the cost of bringing a new drug to market at from 500 to 800 million dollars. Data handling and pickup costs related to patient records account for a staggering 30 percent of drug development costs. Dig deeper into the issues Information Mediary has addressed in past reports and discover some further numbers on the cost of tracking non-compliance in clinical trials settings.

Randomization

Of course we are all aware of the central role played by randomization in the clinical research process. Virtually all clinical research employs this technique. However clinicians are generally surprised to hear that the majority of science proceeds quite nicely without the use of this strategy. The physical sciences get along quite nicely without randomization.

Sometimes you have to spend money to save money. Vials with microchips, beeping blister packs and other new pharmaceutical delivery media, even if they are a bit pricey, could lower overall health care costs.
By David L. Bloom

In ancient Greece, the Father of Medicine himself observed that patients hampered their own healing by straying from treatments prescribed for them. Hippocrates cautioned his students to be wary of noncompliance. Twenty-four centuries later, the problem persists and is a significant deficiency in the managed care system. As physicians and plans face demand for higher treatment quality at lower cost, the focus will increasingly fall on drug misusage.