ASH Clinical News ACN_4.4_FULL_ISSUE_DIGITAL | Page 56

Contract Research Organizations for clinical trials must be clear and predict- able,” the authors noted. “There also must be even more cooperation, collaboration, and communication among regulatory bodies, research sponsors, and CROs.” 1 Mr. Feldman pointed to TransCelerate BioPharma, a non-profit organization formed by pharmaceutical industry members, as a leader in this effort. Since 2012, its mission has been “to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.” 8 In 2015, TransCelerate released its first Common Protocol Template (CPT), a guideline for designing “harmonious” clinical trial protocols. “Having a CPT will ease protocol interpretation and review by sites, IRBs, and regulators,” Dalvir Gill, PhD, TransCelerate chief executive officer explained. 9 “Protocols have become increas- ingly complex and difficult to navigate, with sponsors providing protocols in their own structure. Sites spend time deconstructing and interpreting protocols when that time would be better spent with patients.” The latest update to the CPT, issued in December 2017, aligns with the NIH-FDA Joint Leadership Council’s protocol tem- plate, originally designed for NIH-funded studies. “Following a harmonized template will also e