Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers.
Consequently, the clinical climate has seen unprecedented escalation in federal regulation to ensure that the integrity of the products that are delivered to the global market, are safe, efficient, and reliable. Nevertheless, it stands to reason that if the clinical process was properly designed, monitored and implemented, then the benefits passed onto consumers would not simply be therapeutic, but financial as well. Efficiency is the key to eliminating unnecessary practices within a clinical trial; hence, the most critical phases are those that precede its initiation, design and implementation. The ability to customize and regulate development can drastically reduce the inflated costs typically associated with clinical trials.
Regulatory agencies do not require clinical trials to be expensive. They simply demand that the drugs are scientifically proven to be safe and efficient. Whether or not clinical sponsors have grasped this concept is unknown, but a new paradigm has been evolving to break down the clinical process to allow a more thorough, streamlined process to exist.
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