dijous, 13 d’agost del 2015

Gathering Background for Effective Preclinical Study Design

Surpass BlogBy Mark Cunningham, PhD, Surpass, Inc.

Preclinical in vivo research is valuable and often necessary in the evaluation and development of therapeutic products (drugs, medical devices, biologics, and combination products). It is very important that a preclinical study is properly designed, conducted, analyzed, interpreted, and reported to ensure the work provides scientifically valid information to support product evaluation and development, and that the research is conducted according to defined regulations (USDA, IACUC, FDA, etc.). Surpass has compiled a white paper outlining key steps to generating a well-designed preclinical study and issues blog posts on preclinical research with helpful hints for conducting certain types of studies.

In this post, the process of gathering background information to optimize preclinical study design will be discussed. Background information is not only required for in-house projects and studies but is absolutely needed by preclinical contract research organizations (CRO’s) for putting together an appropriate and accurate study budget, timeline, study design, study protocol, and IACUC submission.

Define the Goals of Your Study

Good study design begins with a clear and thorough understanding of why an in vivo preclinical study is to be conducted, or what is the intended purpose or objective of the proposed study. A good understanding of the purpose or objective of the study will direct much of the specific background information that should be gathered. Examples include objectives related to ongoing research and development programs, a well-defined regulatory submission, an external grant or contract opportunity, to establish a proof of principle concept, definitive safety or toxicology assessment, confirm data generated in another lab (or previously published data), or to generate data to increase the value of a product intended for partnering.

 

Know Your Test Article

It is important to know of any data that has already been generated with the product (test article), any changes that have been made or are intended to be made in the product since the generation of the previous data, the intended therapeutic target(s), the proposed mechanism of action of the product, the clinical setting in which the product will be used, and the desired effect of the product in the target population.

 

Understand the Competitive Landscape and Regulatory Pathway

A list of current products targeting the same therapeutic indication that are approved or that are in development by other companies is extremely valuable, both within and outside of the US. This information is useful prior to conducting literature searches to broaden the search and to help identify the preclinical study designs, in vivo models, study endpoints, and results that were obtained with these other products. Knowing the proposed regulatory classification and pathway for approval of the product may be helpful for the identification of any guidance documents that may be available.

 

Have a Clearly Defined Timeline

A clear understanding of expected or desired timelines associated with the proposed study is another source of information to be aware of. Timelines include when you need to have study budgets, contracts, protocols, and reports completed. When do you want to begin and end the in-life portion of a study? Timelines are also associated with the availability and procurement of critical study supplies and equipment; and key study personnel and consultant availability.

By preparing oneself and gathering all the relevant background information in advance, you are setting your study up for success.

About the Author: Mark Cunningham, PhD, is Chief Scientific Officer at Surpass, Inc., a preclinical contract research organization with labs in the Silicon Valley and Greater Twin Cities. Mark has more than 25 years of experience in translational research and preclinical testing of medical devices, pharmaceuticals, and biologics. Dr. Cunningham’s Bio

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post Gathering Background for Effective Preclinical Study Design appeared first on MassDevice.



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