Revisiting Partnerships 2010:MCC Clinical Trial Performance Metrics – an industry-Wide Effort

Partnerships in Clinical Trials is taking place this March 30-April 1, 201a in Phoenix, Arizona. Every Friday leading up to the 20th anniversary of the event, we'll be recapping one session from Partnerships in Clinical Trials.

MCC Clinical Trial Performance Metrics – an industry-Wide Effort to Develop and Implement Standardized Performance Metrics

Workshop Presenters:
Cory Gutterman, Assoc Dir, Outsourcing Global Pharma R&D, Abbott Laboratories
Jennifer Holmes, Sourcing Relationship Manager, Global Medical R&D, Eli Lilly & Co.
Mike Minor, VP, Proposals and Business Information, ICON Clinical Research
Guy Mascaro, President, Metrics Champion Consortium

Part I: An Overview of the Metrics Champion Consortium (MCC) Clinical Trial Performance Metrics Initiative

Biotech, Pharma, and Service Providers started this initiative in 2007 in response to growing internal demands for standardized performance metrics around outsourced services, particularly central laboratory metrics. Since inception the initiative has expanded to include metrics for imaging and clinical trials. The beta version of the tool was provided last year during Partnerships 2009, distributed for trial implementation and feedback from participating members.

The metrics themselves are designed to address Clinical Operations, Business Operations, Drug Supply, and Regulatory Compliance. Metrics must be high level and actionable, either leading or lagging as indicators, and benefit both the sponsor and the service provider. There are four types or categories of metrics utilized. These comprise and measure (1) cycle time or time to complete a given task, (2) timeliness or ‘on-time’ measurements, (3) quality, and (4) efficiency or cost. Over 40 metrics exist currently and as processes evolve within the industry it is anticipated that metrics will continue to be developed as appropriate.

One example would be within Clinical Operations where metrics were designed to address the study start-up process. It was felt that ‘study start-up’ being of primary importance to study outcome deserves significant attention. Within ‘start-up’ weighted tools are implemented to review regulatory compliance, dosage formulation and administration, screening, and protocol specific issues including CRF review. Amongst teams that have implemented the beta version of these metrics during the past year the reported study outcomes and tool assessments have been positive.

Ultimately a blinded database, built using a Global Clinical Spotfire Tool Set, is intended to allow sponsors and service providers’ access to the pooled data. For instance, one could query start up times for various world regions, or how many sites in the region have participated in oncology studies, etc. It is possible that service providers would be able access their individual company data to review internal performance across the various metrics. The MCC – CMR International Alliance Partnership board of directors, steering committee, and members are discussing maintaining appropriate confidentiality within a model allowing ‘value-added’ and actionable data analysis.

Part II: Breakout Sessions identified challenges, internal stakeholders, and benefits to implanting metrics within the organization. Some of the issues raised are listed below.

Challenges
-Are the number of metrics, 40, too many? Should a core set be developed?
-Can the business value be defined?
-What is the potential for loss of competitive advantage?
-Is there sufficient time and resource within the organizations participating?
-Are goals appropriately aligned between procurement and operations to allow effective utilization?

Stakeholders

There are corporate, regional, and local stakeholders that need to buy in to the process.

Requires an executive level champion.

Benefits
-Start-up efficiency
- Identification of gaps and issues
- Focused oversight
- Drives sponsor/service provider discussion

Part III Incorporating Performance Metrics in CRO Contracts

The premise to Part III is that the requirement for collection of metrics and the definition of those should be incorporated into the contract, presumably a Master Services Agreement (MSA) helping drive not only operational excellence but feeding back to business excellence and improved risk assessment for both sponsor and CRO. Imperative is the application of standardized metrics to both internal and external process applicable to both sponsor and service provider in order to drive constructive dialogue and performance improvement.

Specific examples are provided in two case studies available in the workshop slide deck. Interestingly, specific agreement on metrics for both sponsor and CRO resulted in improved rejection rates within the CRO whereas the sponsor was unable to achieve the same success on return deliverables. This led to more work for the CRO and improved costs and efficiency for the sponsor.


Posted By: ronald norton