Chapel Hill, NC ? April 29, 2015 ? Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, helps customers understand special protocol assessments (SPA) in a new white paper. Titled, “To SPA or Not to SPA: That is the Question,” Rho experts expound on the Food and Drug Administration’s (FDA’s) “Guidance for Industry: Special Protocol Assessment,” providing strategic recommendations for effective use of SPAs in product development, specific to phase 3 clinical protocols.
“SPA guidance has been developed over the course of more than 10 years to encourage product sponsors to interact with the FDA prior to initiating phase 3 programs,” said David Shoemaker, Senior Vice President of Research and Development at Rho. “Through the years, we’ve heard as many stories of SPA interactions dragging on way too long as we’ve heard about these interactions facilitating drug development. The guidance in the new white paper will help pharmaceutical companies determine the most effective and efficient way of using SPAs.”
The lack of success in utilizing SPAs are typically driven by several factors, including failure to provide FDA with an adequate scientific and regulatory clinical protocol and statistical analysis plan; failure to provide clear and concise questions regarding the clinical protocol; and failure to negotiate with FDA on a scientific and regulatory basis regarding the clinical protocol design.
Solutions to Avoid SPA Failure Include:
1. Define success for the primary objective clearly and quantifiably. Clinically, scientifically, statistically and regulatorily identifying the appropriate clinical endpoint, and ensure sufficient due diligence is performed before approaching FDA.
2. Do not underestimate the importance of the questions – provide concise questions to help make the most out of this opportunity to interact with FDA.
3. Submit SPAs with an open mind to feedback.
The white paper goes on to provide recommendations for optimal use of SPAs, as well as appropriate alternatives to consider when SPA is not a fit.
To learn more about Rho, or to read the full white paper, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 31 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.
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“SPA guidance has been developed over the course of more than 10 years to encourage product sponsors to interact with the FDA prior to initiating phase 3 programs,” said David Shoemaker, Senior Vice President of Research and Development at Rho. “Through the years, we’ve heard as many stories of SPA interactions dragging on way too long as we’ve heard about these interactions facilitating drug development. The guidance in the new white paper will help pharmaceutical companies determine the most effective and efficient way of using SPAs.”
The lack of success in utilizing SPAs are typically driven by several factors, including failure to provide FDA with an adequate scientific and regulatory clinical protocol and statistical analysis plan; failure to provide clear and concise questions regarding the clinical protocol; and failure to negotiate with FDA on a scientific and regulatory basis regarding the clinical protocol design.
Solutions to Avoid SPA Failure Include:
1. Define success for the primary objective clearly and quantifiably. Clinically, scientifically, statistically and regulatorily identifying the appropriate clinical endpoint, and ensure sufficient due diligence is performed before approaching FDA.
2. Do not underestimate the importance of the questions – provide concise questions to help make the most out of this opportunity to interact with FDA.
3. Submit SPAs with an open mind to feedback.
The white paper goes on to provide recommendations for optimal use of SPAs, as well as appropriate alternatives to consider when SPA is not a fit.
To learn more about Rho, or to read the full white paper, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 31 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.
Help employers find you! Check out all the jobs and post your resume.
