Rho Offers Tips for Cellular Therapy Studies
CHAPEL HILL, NC - Jul 17, 2018 - For Immediate Release
Rho Offers Tips for Cellular Therapy Studies
CRO shares challenges for cellular therapy in clinical trials
Chapel Hill, NC ̶ July 16, 2018 Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, offers tips on overcoming the challenges associated with cellular therapy clinical trials.
Successful cell therapy can result in more targeted, more effective treatments, and we are conducting several studies using cellular therapy to treat diseases ranging from systemic lupus erythematosus to organ transplantation, said Heather Kopetskie, MS, senior biostatistician at Rho. Our work with cellular therapy has uncovered some unique challenges, and we are working with sponsors to share our expertise in overcoming these issues.
Cell therapy is a form of treatment that uses different types of cells, such as stem cells or regulatory T cells from a patient or donor. These cells are typically reprogrammed to carry out a new function to aid in the treatment of a disease. The ability of cells to carry out more complex functions as compared to drugs can result in a more targeted and effective treatment, which is increasing the popularity of these
therapies.
In many disease areas, however, cell therapy is still a new concept, and new challenges are presented with each study. Tips for overcoming these challenges include:
1. Consider the unique logistics involved with cellular therapies, which require highly specialized laboratories to manufacture investigational product. Centralized manufacturers are commonly utilized, so its important to keep logistics such as packaging, temperature storage, and shipping days in mind when using multiple study sites. For example, clear communication can ensure that extracted cells will not arrive at the manufacturer on a Saturday or Sunday when lab personnel may not be available to immediately process cells.
2. Protocols must always be precise, but the complexity of cellular therapy demands even more precision. For example, the criteria for subject accrual should be clearly outlined. Is it the number of subjects that receive a minimum number of cells or subjects that receive any cells? Detailing scenarios around potential shortages of cellular products in the protocol can help mitigate issues.
3. Timing is key to any clinical trial, but there are unique concerns when it comes to timing for cellular therapy trials. The creation of enough cellular product must be confirmed at multiple stages to ensure the trial stays on schedule, which can be a challenge when drugs are administered in addition to the cellular material or subjects are re-evaluated for eligibility throughout the trial. Planning ahead and building in sufficient time for these timing concerns can help avoid costly scheduling changes later on.
Keeping these considerations in mind early will help study teams design a very robust protocol that addresses these issues, which in turn will help cellular therapy studies run more smoothly.
To learn more, 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 34 years, Rho has been a trusted partner to some of the industrys 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.
