Case Study

Clinical Study Program in Oncology

...A Global, Peri-Approval, Clinical Study Program in Oncology

Investigator initiated trials are used to widen prescriber experience of a drug around the time of launch. New products may elicit numerous and frequent requests to allow the use of the agent in regimens or settings that may or may not be part of the final approved label. Although these requests may be of interest to the sponsor company, they are often considered on an individual basis without reference to development strategy or regard to how this would fit into an overall peri-launch strategy including a publication plan.

Consequently, there is a need to capitalize on prescribers’ interest in a new drug and to channel this interest into a programme that will explore, in a controlled way, the utility of the drug in different therapeutic regimes and settings. Structured investigation should lead to a greater proportion of complete studies and successful publication or presentation of results.

Using this approach, potential supplementary indications may emerge to be part of the life-cycle management of the drug. This approach will also allow for a prospective planning of publications, avoid duplication and allow a broader spread of study designs. In addition, where endpoints are similar across studies, this approach allows for a consistent way in interpreting results thus allowing cross-study comparability and, in particular, standardization in safety reporting.

The Fulcrum Effect

The customer is a large, global, pharmaceutical company with an extensive network of affiliate companies. Phase IV studies are undertaken within the global development function, or more often by global marketing and/or affiliates. The customer had not previously attempted a coordinated, investigator-led programme of trials before and the in-house resources were already stretched to the point where a variety of external resources were necessary. Finally, the customer was in the process of gaining global regulatory approval and launching an important new product that it wished to support with a large, driven and structured programme of investigator-led clinical trials.
The objectives of the investigator-led, clinical trial programme were several-fold:

• Ensure at least one active investigator-originated clinical study in each major territory (country or major region within country) at time of launch
• Generate maximum visibility of company and product in front of future prescribers, especially critical hospital sites for commercial success
• Increase product “noise” and awareness
• Achieve a publication stream over two to three year period post-launch (providing international and local conference/symposia opportunities)
• Increase product knowledge (safety data and ‘hypothesis-generating’ efficacy data)

Together, Fulcrum and the customer defined those factors that would be critical to a successful outcome and against which Fulcrum's performance might be measured:

• Tools and processes to support the project both across departmental and geographic boundaries
• High impact through rapid response to investigator requests and targeting a minimum of 35 studies across the US, Europe and other territories.
• Consistent and high standards of quality to meet international regulatory, medical, ethical and corporate requirements
• Adequate manpower and operational infrastructure to ensure availability of medical, statistical, medical writing and data management expertise when required
• Strong branding to ensure that the product and customer are identified together

Fulcrum's Contribution to Success

Fulcrum provided central project management, co-ordination and communication, including:

• Drive and co-ordinate critical activities involving Fulcrum, internal (customer) and external (suppliers) resources
• Define and implement programme-specific processes (e.g. protocol and documentation design, writing and distribution, protocol/publication review and approval)
• Manage programme communication including set-up and use of a specific web-site and study tracking tools
• Coach marketing affiliates where necessary, in implementation of studies
• Set up a dedicated Data Management Group for data warehousing to provide consistent CRFs and statistical analysis
• Provide medical resources to a supplement those of the marketing company where necessary

The success of the project has meant that the number of studies has increased from 35 to 80 and now involves sites in 15 countries, including the clearing of a backlog of proposals pre-dating Fulcrum's involvement. Final (approved) protocols and CRFs (as necessary) have been delivered quickly (usually within 8 weeks of receipt of study request) to allow fast study start up and maintain the motivation of investigators.

Quality and consistency across studies has been ensured using specific processes such as agreed templates for documents and databases, defined and agreed study end-points and agreed statistical methodology. Fulcrum co-ordinated the management of, and input to, protocol preparation, study reports and draft publications including:

• Scientific review – both within and across studies (including clinical, pharmacokinetic, pharmacodynamic and other specialities as appropriate)
• Statistical review
• Review against drug development standards (GCP, in-house)
• Ensuring poolability and consistency of data
• Application of consistent approaches (including document formats and standards)
• Case record form production
• Adequate manpower and operational infrastructure

Fulcrum designed and delivered a project infrastructure using a virtual approach, supported by specific processes, tools and technology that could be expanded as necessary to meet demand. The virtual approach adopted by Fulcrum is based on the selection and management of appropriate outsourced resources including:

• Central data bases for study data
• Medical writing resources (several suppliers)
• Statistical and clinical experts (suppliers and academic experts)
• Monitors (where necessary)
• Specific individual study requirements (e.g. external laboratories)

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