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International Clinical Trials

From Evolution to Revolution

 

The use of standardised clinical trial performance metrics is achieving quality improvement and mitigating risk in product development in an effort to align with changing initiatives supported by governing agencies such as the FDA and EMA. Traditional business intelligence reporting typically relies on lagging information with changes occurring in an evolutionary fashion; which includes maintaining process optimisation and mastering the basics. The MCC membership has been working collaboratively to take a different, more revolutionary approach to business intelligence. Their efforts have focused on developing innovative changes that are based on leading information and business analytics. This renaissance is being accomplished through business process reengineering (BPR) – the rethinking and redesign of how an organisation uses its existing resources (1).

BPR is more than just minor improvisations that businesses make for organisational and operational gains. BPR seeks to help organisations to fundamentally rethink how they do their work in order to improve customer service, dramatically cut operational costs, and become world-class competitors. A key catalyst for reengineering has been the continuous development and deployment of sophisticated information systems and networks. Leading organisations are becoming bolder in using this new technology to create innovative business processes, rather than merely refining current ways of doing work. It is in this area that the MCC membership has devoted significant time and resources to change the current paradigm of conducting and managing clinical trial operations.

The MCC membership, through the activities of its Steering Committees and various Work Groups, has undertaken a global re-examination of the clinical trial development process. The Work Groups went through a rigorous exercise of deconstructing the clinical trial process into specific activities and measurements to identify improvement opportunities across the development model; resulting in an effective proccess map by which to guide the development of standardised performance metrics. The current MCC process maps, with their stepwise standardised performance metrics, companion metrics and quality-focused scoring tools, are ushering in a revolutionary path for clinical trial development and implementation. This reengineering approach is intended to help member companies identify, analyse and redesign core business processes, with the aim of achieving dramatic improvements in critical performance measures, such as efficiency, quality and speed.

New Partnership

In 2009, the MCC Board of Directors decided to further the goal of achieving the reengineering of the clinical trial development process by embarking on the collaborative development of a member-supported blinded benchmarking database. After an extensive due diligence and discovery period, the MCC’s senior leadership selected IBM and its Life Sciences Cloud as the valued partner for developing this benchmarking database platform. The global intent of the blinded MCC Benchmarking Database initiative is to:

  • Develop a blinded member database, utilising IBM’s Life Sciences Cloud platform
  • Provide robust, near-real-time reporting tools to enable internal and external (blinded) comparisons
  • Create the ability to perform predictive analytics necessary for identifying performance drivers
  • Offer training for implementation and utilisation of metrics to optimise business processes

The MCC and IBM partnership effort provides an opportunity for the two organisations (which have parallel visions and missions) to combine complementary capabilities in support of the MCC’s desire to improve the design and implementation of clinical trials. The blinded MCC Benchmarking Database is a key component of IBM’s Life Sciences Cloud services to support clinical trials from ‘first in human’ through regulatory approval and post-marketing support. The MCC initiative will leverage IBM’s existing capabilities to establish and extend foundational reporting capability to provide predictive analytics in the near future.

Currently, the MCC leadership is working with several of its member organisations to participate in the initial pilot programme, which will focus on developing the working requirements of the blinded database, data gathering requirements and initial reporting capabilities. We anticipate that up to 10 member companies will participate in this first phase, which we expect to begin no later than Q3, 2012 and run through the end of Q1, 2013. 

A Changing Regulatory Environment

Quality risk management is a process for identifying quality-related issues associated with a product’s development, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the control. An effective quality risk management programme helps to ensure the highest quality of drug product developed for patients. For the past several years, multiple global regulatory authorities (for example the FDA, EMA and MHRA) have focused on aspects of quality risk management, and have recently issued guidance documents in support of their efforts (2-4). The overall consensus is that:

● Quality should be ‘built into’ the design and execution of studies

● Quality cannot be achieved by oversight or monitoring alone

● Everyone plays a key role in ensuring quality is achieved

This direction is in line with the FDA lead Clinical Trials Transformation Initiative’s (CTTI) Quality by Design approach, which emphasises building quality into a process during development, rather than attempting to manage quality into a process retrospectively (5).

Using Metrics to Succeed in a Dynamic World

In parallel with the efforts of the global regulatory agencies, since 2007 the MCC membership has focused attention on developing and implementing standardised clinical trial performance metrics throughout the clinical trial process. Some of these metrics are used as key indicators for performance, quality and risk within organisations and across partnerships. To drive quality throughout the design and execution process, the MCC needed to determine how best to define quality. The MCC’s Process Improvement/Quality Management Work Group elected to adopt the ISO 9000 definition of quality, which asserts that “the quality of something can be determined by comparing a set of inherent characteristics with a set of requirements” (6). Following this definition, the Work Group drafted a set of requirements against which their organisations could compare study design and characteristics, to establish whether they are meeting quality guidelines. The ISO 9000 definition also notes that “quality is, therefore, a question of degree.” Based upon this definition, the membership has developed and is piloting MCC Quality Scoring Tools, which provide the underlying support for an effective quality management approach for both portfolio and study-level management. The ultimate goal of the MCC Quality Scoring Tools is to establish a reasonable threshold with which to monitor, evaluate and measure protocol development, site selection and study conduct to support attainment of quality goals. The Work Group felt that the act of measuring should appropriately modify behaviour by providing positive reinforcement for aligning with quality requirements. Scores derived from these tools highlight protocols and sites at risk for poor performance; allowing sponsors and CROs an opportunity to proactively manage and/or mitigate potential risks throughout the course of the study by addressing areas identified as concerns.

It is important to note that the focus should not be on simply developing benchmarking scores, but rather using the tools and standardised performance metrics to assist in rational discussions amongst teams developing protocols, selecting sites and/or evaluating performance at study start-up and through study conduct. This approach provides a proactive and effective means to help ensure that quality is designed into a protocol, as well as its implementation.

References

  1. Business Process Reengineering Guide, Version 3, GAO, May 1997, available at www.gao.gov/special.pubs/bprag/bprag.pdf, accessed on 26 March, 2012
  2. Reflection Paper on Risk Based Quality Management in Clinical Trials, available at www.ema.europa.eu/docs/en_GB/document_library/ Scientifi c_guideline/2011/08/WC500110059.pdf, accessed on 26 March, 2012
  3. Guidance for Industry Oversight of Clinical Investigations – A Risk- Based Approach to Monitoring, available at www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM269919.pdf accessed on 26 March, 2012
  4. Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products, available at www.mhra.gov.uk/ home/groups/l-ctu/documents/websiteresources/con111784.pdf, accessed on 26 March, 2012
  5. Clinical Trials Transformation Initiative, available at https:// www.ctti-clinicaltrials.org, accessed on 26 March, 2012
  6. ISO 9000 Quality Definition, available at http://www.praxiom.com/ iso-defi nition.htm, accessed on 26 March, 2012

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Guy A Mascaro is President of the Metrics Champion Consortium (MCC) and oversees all administrative and marketing functions of the organisation. He has over 20 years of experience in healthcare and pharmaceutical management, marketing and product development with companies such as Johnson & Johnson and Eli Lilly & Company. He served as the principle facilitator and consultant on the development of the Laboratory Performance Metrics initiative and founded, with the support and guidance of several sponsor organisations, the MCC as a non-profi t organisation dedicated to the development and support of performance metrics within the biotechnology, pharmaceutical and medical device industries, with the intent of jointly encouraging performance improvement, quality, effectiveness, efficiency and appropriate levels of control. Guy is also the founder and President of ExaroMed, Inc, a medical communications and consulting company.

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