By Karen Ivester, inSeption Group
Autologous cell therapy preclinical and clinical protocol designs differ greatly from other types of pharmaceutical products. Sponsors with little knowledge or experience of the Investigational New Drug (IND) process may initially not realize the complexity of designing these protocols. Driven by competition for both market share and patient populations, an organization’s desire for speed can override its rigor in ensuring protocol designs are feasible.
Autologous cell therapy clinical trial protocol designs benefit greatly from multifunctional, multi-departmental stakeholders’ input and feedback. Sponsors who can tap key opinion leaders to selectively vet and assess protocol elements will help ensure fewer protocol amendments, an IND submission that supports the proposed trial, and even fewer clinical holds.
But autologous cell therapy clinical trial protocol design is not a one-off task; it is a continuous process. As more stakeholders are engaged, new drafts of the protocol are rolled out.