Scientific leadership, on-site project management, centralised contracting and protocol quality-assurance are some of the tools that could help significantly to accelerate start-up, enrolment and overall timelines for clinical trials in the traditionally challenging field of oncology.
Compelling improvements in study metrics were highlighted by the Multiple Myeloma Research Consortium (MMRC), US-based affiliate of the Multiple Myeloma Research Foundation (MMRF), in a retrospective review of 25 multiple-myeloma trials conducted with MMRC project management resources between May 2006 to July 2011.
The data were presented at the recent annual meeting of the American Society of Hematology in San Diego, US. As the MMRC noted, cancer trials are “notoriously difficult to enrol and complete in a timely manner”.
Industry standards show that fewer than 5% of patients take part in oncology studies, which can take as long as two years to design, approve and activate.
The MMRC metrics included comparisons between a set of baseline trials (June 2006 - September 2008) and recent trials (September 2008 - July 2011) run through the Consortium. The more recent studies were based on the model established by the MMRC and the MMRF to accelerate drug development in the field.
Key findings were that:
• The more recent trials opened 28% faster than the baseline trials, which opened within timespans consistent with industry standards (131 calendar days for recent trials versus 181 calendar days for baseline trials).
• All MMRC trials opened 20% faster when all participating Consortium centres were compared for any MMRC trial (189 days for recent trials, 236 calendar days for baseline trials).
• MMRC trials enrolled 10% more patients than their pre-study enrolment commitment, with 89% of trials meeting that commitment.
• MMRC trials recruited patients 10% faster than the baseline trials, with 67% of studies meeting their pre-study enrolment commitment 34%, or 4.5 months, sooner than the baseline enrollment timeline.
The Consortium said it achieved these improvements through a number of targeted programmes implemented at its 16 member institutions and through direct collaboration with industry trial sponsors.
• Scientific leadership. An established team with “decades” of experience in drug discovery and development, along with a network of leading myeloma experts, are used to develop a strong portfolio of trials with promising therapies.
• The MMRC Project Management Network. This system is designed to improve on-site project-management and to expedite the study protocol, budget and institutional review-board approval processes.
• Centralised contracting. This involves working centrally to co-ordinate with legal teams across multiple institutions and setting up multi-party contract agreements to accelerate the clinical-trial contract approval process.
• Protocol quality assurance. Proposed multiple myeloma study protocols are reviewed with industry sponsors before they are sent on to the US Food and Drug Administration and, eventually, the MMRC.
• MMRC investigator-sponsored trial platform. This enables MMRC investigators to conduct multicentre studies of the same quality as company-sponsored trials, the Consortium says.“We are working to break down the barriers that prevent timely completion of clinical trials in ways which we believe can serve as a model far beyond multiple myeloma,” commented Kathy Giusti, founder and chief executive officer of both the MMRF and the MMRC.