Pharmaceutical and medical device companies now place more of their vital research & development capabilities into the hands of contract research organizations (CROs). In doing so they take the risk that such CROs can deliver the required information on time and to the required standard. In many cases, CROs function as strategic partners with industry sponsors, providing a wealth of expertise while helping to reduce costs and accelerate product development.
Regardless of your study type, goals or expected outcomes, when it comes to preclinical protocols, careful and informed decisions drive success. Companies are well advised to seek out seasoned experts in the field who can share insights into preclinical development efforts, including in study design, protocol development, animal models, screening and sourcing, delivering and dosing, quality control and regulatory compliance.
With decades of experience in preclinical study design and management, the preclinical CRO of Wake Forest Innovations, the industry-engagement arm of Wake Forest Baptists Medical Center, helps our clients get the data they require to make informed decisions about the development of their candidate medical device or drug. Below we have outlined seven critical steps that can help your preclinical study succeed.
Seven Steps for a Successful Preclinical Study
1. Write a strong protocol
As companies transition from basic research to product development, it is imperative that preclinical work be driven by a strong protocol. Preclinical studies require myriad decisions, including: appropriate animal model, sample size, randomization and bias, reproducibility, documentation and regulatory compliance. With a clear study objective, the protocol has a higher chance of producing valid results.
2. Conduct an exhaustive literature review
Before developing a protocol, researchers should familiarize themselves with prior studies carried out in their area of interest. This literature search should be done exhaustively. Preclinical research methods are evolving rapidly and the most successful studies build upon a foundation of extensive prior research in the field.
3. Select the right animal model
It is critical for companies conducting preclinical studies to select animal models that will generate valid and predictive results. Numerous studies have shown that phylogenetic similarity does not necessarily predict similar response between animal models and humans. Therefore, it is critical to carefully select the most appropriate species, sex, age, size, life span, etc. as all of these decisions impact study outcomes.
4. Screen animal models for targeted disease and biomarkers
A first-rate CRO will be able to screen and source animal models who are positive for virtually any disease process, including breast cancer, uterine cancer, diabetes and heart disease. A significant portion of ‘rescue work’ by CROs unfortunately comes from scenarios where companies were unable to either induce the disease or target biomarkers for the disease.
5. Ensure consistent sourcing of animals
Once researchers have selected a particular species, it often is important to ensure that the animal models being used in a given study all come from the same geographical region. For example, nonhuman primates (NHPs) of Chinese origin may be quite different in physiologic responses than NHPs of Indonesian origin, or of Vietnamese origin, and so forth. In such cases, once a country of origin has been established, it is important to continue sourcing from the same region to account for species variability.
6. Provide proper nutrition
When testing a therapeutic, the animal model must be fed a diet that mirrors the diet of the patient population. Moreover, the model must be susceptible to the same dietary-induced effects seen in humans. Otherwise, researchers may generate false negatives or false positives, squandering time and resources.
7. Use the proper technique
Researchers must use proper handling and surgical techniques. For example, a device implanted without proper attention to pre-operative preparation, post-operative care, wound healing, bacterial contamination, tissue damage and trauma, can appear histologically to be non-biocompatible. Similarly, issues of dosing, metabolism, delivery of therapeutics, social environment and animal husbandry can affect outcomes and must be managed with meticulous care.
At Wake Forest Innovations we work with pharmaceutical and medical device companies worldwide to design and manage studies based on the seven steps listed above.
Our client partners tap into our comprehensive experience with preclinical bench testing of pharmaceuticals and medical devices in all phases of development. A nationally recognized research facility, we have the nation’s largest cohort of veterinarians working with animal models on diseases of human relevance.
Contact us for more information about our services or to schedule an exploratory meeting.