At the core of innovation and development in the biomedical field is the clinical trial. In order to realise new ideas and bring new products to the markets for public consumption stringent clinical testing must be performed to establish both the safety and efficacy of the nascent product.
But each new concept and innovation is by definition unique which means that every product requires a specific clinical trial design be applied to it. Using customized assays means clinical trials are developed with the particular properties of the product being tested taken into consideration. The more tailored to the questions being addressed that the assays are the more accurate and relevant the data obtained for it is.
With so many variables in play, the clinical trial can easily be formulated without taking one or more of the specific products complexities into account. Such an incomplete trial design can jeopardise the ability of the study to demonstrate the safety and effectiveness of a drug or product.
With the correct application of assay such pitfalls can be avoided particularly in light of adhering to legislation and regulatory requirements.
Across the globe governments apply strict regulation to the production, sale and distribution of pharmaceutical drugs and products. This legislation requires drugs be put to rigorous testing before they can be sold to the public. Quality assays for clinical trials can ensure that the testing applied to the product is comprehensive and accounts for all legislative stipulations as well as any possible future regulatory compliance.
Not only does the final assay need to ensure that the product meets regulatory requirements but also that as much relevant information as possible is obtained about the new drug.. Small biotech companies that are dependent on a single or few products are particularly vulnerable as one inconclusive trial can undermine their entire business.
Clearly, assays development is not an area in which to try to make savings. Ensuring that the study is developed to the highest possible standards and is as comprehensive as possible will result in a return on investment in more than simply financial terms. This the critical point in the development of a product where the future success of the product is determined.