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Published on: January 22, 2013
RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting
Angela Meade1, Bhavna Oza1, Eleni Frangou1
1MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Abstract:
The development of therapeutics in oncology is a highly active research area for the pharmaceutical and biotechnology industries, but also has a strong academic base. Many new agents have been developed in recent years, most with specific biological targets. This has mandated the need to look at different ways to streamline the evaluation of new agents. One solution has been the development of adaptive trial designs that allow the evaluation of multiple agents, concentrating on the most promising agents while screening out those which are unlikely to benefit patients. Another way forward has been the growth of partnerships between academia and industry with the shared goal of designing and conducting high quality clinical trials which answer important clinical questions as efficiently as possible. The RAMPART trial (NCT03288532) brings together both of these processes in an attempt to improve outcomes for patients with locally advanced renal cell carcinoma (RCC), where no globally acceptable adjuvant strategy after nephrectomy currently exist. RAMPART is led by the MRC CTU at University College London (UCL), in collaboration with other international academic groups and industry. We aim to facilitate the use of data from RAMPART, (dependent on outcomes), for a future regulatory submission that will extend the license of the agents being investigated. We share our experience in order to lay the foundations for an effective trial design and conduct framework and to guide others who may be considering similar collaborations. Trial Registration: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39. CTA #: 20363/0380/001-0001. MREC #: 17/LO/1875. ClinicalTrials.gov Identifier: NCT03288532 RAMPART grant number: MC_UU_12023/25. . RAMPART Protocol version 5.0.
Insights
The RAMPART trial uses adaptive designs and academic-industry partnerships to evaluate new oncology therapeutics for advanced renal cell carcinoma (RCC). This approach aims to efficiently identify promising treatments and improve patient outcomes in an area lacking standard adjuvant strategies.
Area of Science:
- Oncology drug development
- Clinical trial methodology
- Renal cell carcinoma research
Background:
- Oncology therapeutics development is a dynamic field requiring efficient evaluation methods.
- Adaptive trial designs and academic-industry collaborations are emerging solutions.
- Locally advanced renal cell carcinoma (RCC) lacks a universally accepted adjuvant strategy post-nephrectomy.
Purpose of the Study:
- To improve outcomes for patients with locally advanced RCC.
- To evaluate novel therapeutics using adaptive trial designs.
- To foster academic-industry partnerships for efficient clinical trial conduct.
Main Methods:
- The RAMPART trial (NCT03288532) employs adaptive trial designs.
- It involves collaborations between academic institutions (led by MRC CTU at UCL) and international groups, including industry.
- The trial aims to facilitate future regulatory submissions for investigated agents.
Main Results:
- The RAMPART trial is designed to streamline the evaluation of multiple oncology agents.
- It focuses on identifying promising treatments while efficiently screening out less effective ones.
- The study aims to establish a framework for effective trial design and conduct.
Conclusions:
- The RAMPART trial exemplifies a combined approach of adaptive design and strategic partnerships.
- This model seeks to enhance the efficiency of clinical trials for oncology therapeutics.
- The experience aims to guide future collaborations in developing and testing new cancer treatments.
