FAIRFIELD, Conn., June 4, 2013 (GLOBE NEWSWIRE) -- Competitive Technologies, Inc. (OTCQX:CTTC) markets and sells the Calmare® medical device for the treatment of neuropathic pain. CTTC encourages investigators to conduct independent clinical trials involving the Calmare device to add to the growing body of research supporting the efficacy of Calmare in treating chronic neuropathic pain.
The following analysis of a recent clinical trial is from the Scrambler Therapy® (ST) official scientific and clinical information website (see http://www.scramblertherapy.org/example.htm), and details the importance of using standard scientific and methodology guidelines.
″Is the outcome of the clinical trial ″A randomized, double-blind study of ″Scrambler″ therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN)″ reliable?
″The main issue that prevents carrying out Scrambler Therapy clinical trials without methodology mistakes and bias is linked to three main variables:
- Non-optimized formation levels in the device usage,
- Incomplete compliance and/or changes to the official standard protocol treatment, and
- Failure to use the STDM support software and ST-NET network.
″The negative effects of these variables have a meaningful impact on the reliability of the clinical trials that can be easily offset by following the official standards.
″The statistical data from the clinical trial mentioned above, however, present a different and unique issue from the ones noted with earlier studies. During the daily treatments, the pain does not seem to have been zeroed out in any of the patients, which is an essential requirement for the effective therapy outcome included in all standard protocols and any other official document. This failure to zero-out pain can occur only when the operator has no knowledge of the methodology and no ability in the correct device usage.
″Ruling out this assumption, there seems to have been an involuntary mistake in the protocol treatment. This can occur in double blind trials due to the rules that prevent communication between the clinical trial team.
″In this case (the only one that seems realistically possible), the original problem can probably be traced back to the sham used in the clinical trial, where from the very beginning a series of intrinsic issues have been identified. This topic is better explained on: http://www.scramblertherapy.org/active-sham.htm.
″In order to overcome this problem Dr. Toby Campbell had been given a protocol that would enable the use of Calmare MC-5A itself as an active sham. This protocol (approved by the Institutional Review Board (IRB) of Pediatric Hospital ″Bambin Gesù″) can make the therapy ineffective even if the patient has the impression of undergoing the normal treatment, since it is using a perfectly functioning Calmare MC-5A device. By so doing, even if the patient has prior knowledge of the device, the placebo effect remains valid, since there are no differences in form or functioning identifiable by the patient.
″The outcome of the patients treated with MC-5A in the above mentioned clinical trial is not in line with the previous scientific literature and normal clinical practice, but rather corresponds perfectly to the provided MC-5A sham protocol usage. Therefore, we have reached the reasonable conclusion that this sham procedure was mistakenly used as normal therapeutic treatment. After all in his role as double blind clinical trial investigator, Dr. Toby Campbell could not verify possible implementation or protocol mistakes, and this seems to have been the case.
″Acknowledging the clinical trial team's good faith, the fact still remains that data that correspond to an incorrect usage of the device have been published at the internationally renowned ASCO Conference.
″Today we respectfully ask Dr. Toby Campbell and the IRB of University of Wisconsin, Madison Carbone Cancer Center to act in order to avoid clinical trials with the same clear issues. This is easily achievable by following the standard official procedures that guarantee reliable clinical trial, summarized as follows:
- Employ operators adequately trained in the methodology who can zero out the pain during the daily treatment in at least 80% of the patients, the minimum average necessary to produce clinical trials without excessive bias;
- Use only official treatment protocols, as well as the support and monitoring provided free of charge to researchers involved in clinical trials. This respects the study's independence without impairing the quality and reliability of the outcomes. One must keep in mind that Scrambler Therapy is a new therapy. Any other previous electro-analgesia experience cannot be used, because radically different and incompatible with ST; and
- Use STDM, a free-of-charge support software and network specifically devised to drastically reduce the operator-dependent variable in clinical trials and normal practice. These support tools immediately inform the operator in cases of treatment anomalies, providing adequate solutions.
″These simple rules make up the current Gold Standard of ST that enables investigators to carry out easily reproducible clinical trials, with homogeneous outcomes. They provide more effective results on the patients, both in quantity and quality, and immediately detect involuntary errors that produce unreliable outcomes.
″Provided that Dr. Toby Campbell and the IRB of University of Wisconsin Carbone Cancer Center will adopt this official Gold standard, we are confident that the next published outcomes will be in line with the current outcome reference standard.
″In the meantime, I thank Dr. Toby Campbell for his efforts in this therapy's clinical trials.″
About Competitive Technologies, Inc.
Competitive Technologies is a global leader in developing and commercializing innovative products and technologies. CTTC is multifaceted, providing distribution, patent and technology transfer, sales and licensing services.
CTTC is the licensed distributor of the non-invasive Calmare® pain therapy medical device, which incorporates the biophysical Scrambler Therapy® system developed in Italy by CTTC's client, Professor Giuseppe Marineo to treat neuropathic pain, including cancer pain. (The official Scrambler Therapy® scientific and clinical information website is at http://www.scramblertherapy.org/english.htm.) The Calmare® device is currently being manufactured for sale by CTTC's partner, GEOMC Co., Ltd. of Seoul, Korea. For more information on the device, visit www.calmarett.com. Visit CTTC's website: www.competitivetech.net.
Statements made about our future expectations are forward-looking statements and subject to risks and uncertainties as described in our most recent Annual Report on Form 10-K for the year ended December 31, 2012, filed with the SEC on May 31, 2013, and other filings with the SEC, and are subject to change at any time. Our actual results could differ materially from these forward-looking statements. We undertake no obligation to update publicly any forward-looking statement.
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