Case Report: Protocol Amendment – Large Oncology Platform Study for a Top 10 Pharma Company
Client
- Top 10 pharma company, Global Clinical Development team
Challenge
- Author and project manage a protocol amendment for a large oncology platform study (eight modular protocols and one core protocol), and author two new modular protocols for the study.
- Coordinate feedback from more than 60 key stakeholders across Europe, the United States, and Japan for the numerous study drugs included in the study.
- Work to client SOPs and policies, and within their document management system, to manage authoring, review, and version control.
Approach
- At the outset of the project, we were provided with a protocol comments tracker; we also liaised with the operations lead to work out which updated external source documents were relevant to the protocol amendment (i.e., Investigator Brochures, protocol templates, and updated risk–benefit and safety information).
- For the new modular protocols, we were told of the planned combination treatments and received relevant source documents (as above).
- A kick-off meeting was held with the client’s team to discuss the key updates, ways of working, and the plan for the two new modular protocols.
- We created a tracker of the updates required to each modular and core protocol, including anticipated dates for delivery of source documents that were not immediately available.
- For the new modular protocols, which included combination treatments, we worked with a lead clinician to determine the entry criteria, potential overlapping toxicities, the toxicity management guidelines, and the schedules of assessments, considering core approaches and study drug-specific requirements.
- The new modular protocols also had to be introduced into the core protocol, and any relevant updates rolled out across all modular protocols.
- During the project, weekly status calls were held with the Clinical Operations Lead, where progress and pinch points were discussed, and to stay organised our internal tracker was consistently updated.
- Alchemy worked to client SOPs and within the client’s document management system to gather feedback on each draft, and liaised with the large number of reviewers to resolve comments.
- At the end of each review round, we ensured updates made by the team were consistently rolled out across all relevant documents.
- Once all review rounds were complete and approvals received, the documents were finalised. We created red-lined and clean versions of the final documents and issued these for publishing and sign-off.
Result
- We produced high quality, internally consistent documents, with very few findings during quality control review.
- The client asked us to author subsequent amendments for the programme, and we are also currently authoring the clinical study reports for each module as they complete.
- At the end of the first protocol amendment, we suggested process improvements to ensure subsequent amendments ran smoothly.
- To successfully deliver this project, our team demonstrated impeccable organisation, agility, knowledge, and communication.
I want to THANK YOU for all your support and effort on this task. We would not have achieved our milestone without having you on this project as a team member. Your skills and smartness have certainly made my/our work life easier. On a personal note, I really appreciate you initiating emails and following up on items on my behalf.
