CPT Testimonials and Value Stories

1. CPT Testimonials and Value Stories December 2017

2. Driving consistency and optimizing process • “Our Company went through several mergers and acquisitions. As a result, we had multiple protocol templates and lack of consistency. Harmonizing around the CPT was an opportunity to streamline the protocol process. Having senior management support, with a mandate for implementation, gave us the framework to move away from multiple legacy templates to our Company’s version of the CPT. We are working toward a single template to incorporate all studies, including Clinical Pharmacology and Device. Currently, we are adding selected instructional and common text to the TC CPT, specific for our products and processes. We have been able to incorporate these without change to the basic backbone of the TC CPT. Our goal is to launch a single version of the CPT for all studies in our company, by year end.” • “We started an internal initiative to create a more streamlined protocol development process. Adopting the TransCelerate harmonized Common Protocol Template will ensure we have consistent and streamlined protocols.” • “By adopting the Common Protocol Template streamlined structure and optimizing our protocol process we are improving our timelines and making life easier on those who write, input, review, approve, and implement our protocols.”

3. Driving consistency and optimizing process • “The Common Protocol Template keeps science front and center. It harmonizes headings and text, while moving more rote components to appendices. It makes protocol development and implementation easier on internal teams, Health Authorities, sites, and patients.” • “Some ideas have started to take hold, e.g., Participant instead of subject or patient, shorter synopses, selective use of liver criteria, keeping contents of sections strictly on target, and no excess or repetitive wording.” • “The technology-enabled version has led to content re-use.” • “Having the Common Protocol Template will reduce re-work in house, lead to harmonization across disease programs, and facilitate protocol writing for less-experienced authors.”

4. Author and Sponsor Reviewer reaction • “In 2016, we launched the implementation of the Common Protocol Template (CPT) with no change in the Table of Contents, and with minimal adjustments in the CPT sections and libraries to meet internal requirements; early adoption by end users started in the middle of 2017 and has been progressing smoothly: To date, their feedback is encouraging with no major roadblocks. Continuous support from major stakeholders has been instrumental to this progress, the benefits outweigh the initial resource and time investment. We strongly encourage others to launch and implement the initiative.” • “As a PRC member, I was reviewing a protocol from a partner company who has adopted the CPT. It made it much easier to review knowing exactly where to go for each piece of information.” • “Our organization had different clinical groups all vying to develop protocols their own way. We have begun using the CPT with some customization on a company-level (not by group). As compounds progress, we plan to continue using CPT, and all groups know it. This has calmed down everyone and resistance is starting to melt.”

5. Investigator focus and Health Authority reaction • “Our teams appreciate the investigator-focused changes in the protocol. We anticipate further savings in terms of site training and ethics committee review time as the Common Protocol Template becomes an industry standard.” • “Our  company has external collaborations and the CPT has been used in two Phase IIa clinical studies to assess safety and efficacy in adults: (1) A randomized, parallel arm, placebo-controlled, double-blind study (2) A randomized, double dummy, parallel arm, placebo & active controlled, double-blind -Health Authorities (MHRA/Poland/Hungary/FDA) had no issues (no comments on the structure) and there have been no issues to date with local Ethics Committees.” • “The potential short- and long-term benefits of having sites start up faster and faster ethics committee and health authority approvals helped us convince our development teams to pilot the Common Protocol Template.”

6. Use by smaller Sponsor organizations • “An integrated solution from protocol to clinical study report (and the pathway to get there) will resonate well with small biopharma companies, who are looking for the benefits of automation and efficiency, but cannot afford a trial and error approach.”

7. Leadership support for implementation • “At my company, the ground swell of activity for the implementation the TransCelerate CPT started when two Senior Management Leaders approved the plan to adopt the structure of the TransCelerate CPT.  There was, and continues to be, a strong focus to adopt the TransCelerate Initiatives whenever possible.  With that Sr. Leader support and directive to “GO DO THIS” to adopt the structure of the CPT, the discussions that I had with the functional groups was embraced, resulting in engaged and focused input from the Subject Matter Experts on their review of the CPT.  The support of these 2 Senior Leaders lending their endorsement of this internal workstream, was essential to the successful implementation and adoption of the TransCelerate CPT structure. My advice is to gain the endorsement of a senior leader, or two, to support your efforts as the ‘champion’ who is working on the implementation of the CPT at your company.”

8. Planning and use of tools for implementation • “To implement the Common Protocol Template at your company: • Understand your internal protocol landscape: processes, functions involved, show-stopper considerations, internal pain-points, and resource demands. • Take time to plan. Engage experts and get early involvement for the best feedback on process and template changes. • Invest time and resources. Create a strong awareness campaign for management, staff, and teams.” • “Use the mapping tool to ensure that the Common Protocol template (CPT) aligns with your company’s end to end processes. The tool allows you to see if anything is missing from the CPT that your company has in its own template.”

9. The journey at one Sponsor organization • “At our company, we were intrigued with the technology behind the tech-enabled version of the CPT as the smart technology offered opportunities for future developments.  When we sought broad cross-functional review of the CPT, we were sure to provide background on TransCelerate and the guiding principles behind the CPT, which smoothed the path by providing the ‘why’ for considering the CPT.  Alignment on the overall structure was obtained fairly easily once we assured the functions that all required content was in the template, but often presented in sections different than our earlier template.  CPT content was found to be much more streamlined than our previous template; we carefully assessed every section and for the majority of sections retained CPT language.  Negotiations were required to align content in several sections; these discussions were limited to areas where the CPT had perhaps not yet fully developed (e.g., statistical considerations, contraception).  In those areas, we created a hybrid of CPT and sponsor text to meet the needs of our trials, however soon to be released versions of the CPT have addressed or will be addressing these areas.  We struggled a bit with the distribution of new releases of CPT and the add-ins.  We attempted to push out the new add-ins from our software center, but after repeated failures (due primarily to our internal systems), we now provide updates on a dedicated SharePoint site and distribute a memo to inform them that a new version is available and to please uninstall the older version and install the new version.  Also, while we were assessing CPT content for the first time, we noticed an initial fear of adoption of the tech-enabled version.  We developed a training plan in which we provided instructor-led trainings, video instruction, and user guides.  We found that as super users, the protocol writers had great success giving a 15-minute mini-training at their kick-off meetings if a team had not yet encountered the CPT.  We did have to hand hold a bit at the beginning and assist with add-in installation, viewing instructional text, etc. in the beginning, but the CPT was implemented almost a year ago and we’ve received very positive feedback from teams.  We have submitted more than 20 protocols globally with no health authority rejections based on the template. ”

10. Thank you