The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.
In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.
At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact.
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional qualification audit process? In this blog, we present Irving’s proposal for an innovative approach that could improve efficiency and allow sponsors to invest more time evaluating the operational and cultural aspects that have greater potential to ensure the success of a partnership
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.
A precise and thorough approach to planning is key for success in data management.
The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when to expect it.
The Society for Clinical Data Management (SCDM)‘s publication, Good Clinical Data Management Practices (GCDMP) (1), provides a complete chapter on Data Management Plans. (The GCDMP is available, even to non-members of the society, at their webpage). It is important to note that while DMPs are not regulated documents, they are in fact so commonly used across the industry they have become auditable, and therefore scrupulously close attention needs to paid to getting them right.
We outline 4 key points to bear in mind when creating or reviewing a Data Management plan.
Use a Standard Template for Consistency
To a great extent, the DMP can, and should be standardized across projects for a consistent approach. When using a centralized biometrics model, where data services( data management, statistics, statistical programming) are conducted by a single provider, the development of such standard documents can represent an efficiency in the study set up, and also reduce the oversight burden for the sponsor. Indeed, for any trial project, a robust Data Management Plan template provides a solid starting point. One of the important challenges facing industry professionals today is the increasing complexity of clinical trials, and as such, great care needs to be taken to ensure the DMP accurately documents what actions will be taken with the trial data. Having a highly experienced data management team working on your project, with a track record of implementing innovative and complex trial designs, therefore, becomes increasingly important in this environment.
Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may have different priorities and processes when working with external vendors to larger pharmaceutical organizations.
Vendor selection is a critical component of ensuring clinical trial success. A 2015 report (1) suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs. The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and functional groups within larger organizations. The RFP process is a critical part of vendor evaluation, involving significant effort from the sponsor and CRO to ensure that a well-constructed, accurate proposal is created which can deliver what the sponsor needs.
Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.
There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25 billion dollars worth of clinical development projects. That is over a quarter of the $98 billion dollars currently devoted to clinical drug development.
This naturally raises several questions: