DRUG DISCOVERY AND DEVELOPMENT 43
Letting contract research organisations take the strain
A successful tie-up with a contract research organisation (CRO) can be a major boon during product development and clinical trials. Eugene McCarthy reports.
Une association réussie avec une organisation de recherche sous contrat (CRO) peut être un atout majeur pour le développement de produits et les tests cliniques. Un article d’Eugene McCarthy.
Eine erfolgreiche Fusion mit Auftragsforschungsinstituten (CRO) kann bei der Produktentwicklung und klinischen Studien ein großer Segen sein. Eugene McCarthy berichtet.
C
Fig. 1. CROs can ease the product development process.
Photo: GSK linical Research
Organisations (CROs) can take the pain
out of product development for pharmaceutical and biopharmaceutical companies by reducing both direct and indirect costs, boosting efficiency and speeding up the time to market of new products (Fig. 1).
Design of clinical trials is an important aspect of this work
and here Pharmaceutical Product Development (PPD) has acquired RCT Logic’s exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison design (SPCD).
Clinical trials SPCD is an alternative method for conducting well-controlled clinical trials that substantially decreases the impact on trial outcomes of any placebo effect and will enable PPD’s clients to significantly reduce the time and cost of conducting their clinical trials.
Tis methodology, which PPD is branding as Trimentum, has been particularly effective in studying major depressive disorder (MDD), but is applicable to clinical trials in many disease areas where outcomes can be
impacted by placebo effects. A total of 22 SPCD trials are completed, ongoing or planned. Tese include Phase II and III trials by corporate sponsors that are licensees of RCT Logic, as well as trials with funding from the US National Institutes of Health (NIH) and charitable organisations.
Placebo effect Te SPCD method greatly lessens the impact of the placebo effect in trials by incorporating two sequential placebo- controlled stages into the process, the second of which includes a re-randomisation of placebo non-responders from the first.
Trials in psychiatric indications are particularly vulnerable to placebo effects due to the subjective nature of the assessments because some of the responses may relate to actual improvement in the patient’s condition while others may relate to expectancy, trial design or implementation flaws.
Due to its basic structure, SPCD reduces the number of patients
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