Oncology
Clinical Trials

Innovative and Technology Supported Clinical Trials

Innovative Approaches to Transforming Oncology Research: Every Clinical Trial Counts

With cancer being second most likely cause of death (after cardiac-related diseases), the focus on developing new oncotherapeutics is immense. However, the traditional drug development pathways in cancer therapeutics have been too slow and have the lowest clinical trial success rate of all major diseases. The answer to this critical problem lies in efficient innovative trials wherein multiple scientific hypothesis can be tested under the ambit of one protocol, called “master protocols”. They not only increase the success rate but also recognize failure faster and at lower cost, to allow the resources and efforts to be directed in an optimized way.

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The traditional approach to clinical development follows a fixed straight-line path and tests a specific scientific assumption throughout the study. Whereas the innovative designs are dynamic in nature and allows to update the study protocol based on the data generated
Sowmya Kaur
Sowmya Kaur Executive vice president, Navitas Life Sciences

The regulatory agencies also have been instrumental in encouraging and promoting innovations in clinical trial designs in oncology.

US FDA on Master Protocols in Oncology (2022)

“The potential advantage of a master protocol is flexibility and efficiency in drug development, consistent with FDA’s goal of helping to make safe and effective drugs and drug combination treatments available to the public. A master protocol provides an opportunity to incorporate efficient approaches, such as a shared control arm and/or the use of centralized data capture systems to enhance efficiency. However, a master protocol can also create challenges in the conduct and analysis of the trial that, if not properly addressed, can increase risk to human subjects or delay the development of the drug”.

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While master protocols can speed up the development route to marketing authorization, they can be challenging to design, conduct and interpret. This necessitates a strategic partnership with a global CRO known for rich clinical, operational, and regulatory expertise in oncology trials.

Gain from Navitas Life Sciences’ Vast Experience in Oncology Trials

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Navitas have supported over 100+ oncology studies with some of the largest global players in the therapeutic area. The experience ranges from First in Human (FIH) dose escalation, dose expansion, confirmatory efficacy to post marketing trials.

Almost all types of solid tumors and hematological indications have been a part of these trials, with investigational agents ranging from traditional chemotherapy to immunotherapy (check point inhibitors, monoclonal antibodies, immunomodulators, cancer vaccines), hormone therapies, and targeted therapies.

Extensive experience in conducting and managing oncology clinical trials across trial types, design, and drug indications has provided the ability to roll out successful road maps for efficient clinical trials.

Navitas Life Sciences

is named as a Major Contender
in Everest Group’s

Clinical Development Platforms Products
PEAK Matrix® Assessment 2022

Wide Ranging Depth of Expertise in Managing End-to-End Oncology Clinical Trials

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*Studies
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Managed sites
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Managed patients

Regional and Local Studies

*: Includes studies with Stand Alone services, FSP models as well as End to End Support services

Multiple Cancer Types Studied

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Global CRO with Rich Experience and Expertise

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Niche Proficiency of Navitas Life Sciences in Successfully Delivering Complex Cancer Trials based on Innovative Designs

Navitas Life Sciences has successfully executed studies involving complex designs, like model-based dose escalation and master protocols. The requirements of these designs are precise, with very narrow room for error. Navitas Life Sciences brings to you experience and capabilities of:

  • Dose escalation studies with both rule-based (traditional 3+3, accelerated titration) and model-based designs (modified continual reassessment method (CRM), time-to-event CRM)
  • Conducting studies based on master protocols (umbrella, basket and platform trials)
  • Differential approach to trials with registrational intent versus exploratory trials designed to assess surrogate markers of benefit
  • Handling multiple protocol amendments inherent to complex innovative designs.
  • Providing sharp statistical support required for the additional complexity in CID, e.g., several potential sources of bias, interim analysis and consequent design modifications, stopping early based on futility analysis, Bayesian statistics etc.
  • Providing medical support with in-depth understanding of targeted therapies, precise eligibility based on biomarkers, specific genetic aberrations, specific radiological assessments (RECIST, irRECIST, RANO for neuro-oncology), toxicity assessment (DLTs, MTD, CTCAE grading etc.)
  • Artificial Intelligence support to through inhouse AI/ML technology platform, OneClinical Analytics.
  • Selecting dedicated investigators and sites which can comply with increased trial complexity including numerous sample collections, more intensive patient monitoring, complex drug administration, and multiple protocol amendments. We do robust feasibility to ensure that sites truly understand the specific target patient profile, for e.g. specific genetic mutations.
  • Making Country selection is based on the clinical trial phase, indication, incidence rate, standards of care, regulatory environment, and protocol complexities
Our experience in submitting CID protocols in oncology for dose escalation to US FDA have been extremely encouraging. These are readily accepted by FDA, and the agency also provides very scientific inputs. The Pre-Investigational New Drug Application (Pre-IND) meeting can be very beneficial to develop a robust design. The world is ready to embrace the change
Atul Gupta
Atul Gupta Vice President,
Medical and Scientific Affairs,
Navitas Life Sciences

Innovative Trial Designs

Get expert insights from Sowmya Kaur, Head, APAC, Navitas Clinical Research, and Global Client Solutions, Navitas Life Sciences together with Dr. Atul Gupta, Vice President Medical & Scientific Affairs, Navitas Life Sciences, from their article, Innovative Trial Designs, published in issue 43 of Pharma Focus Asia.
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Full Service Clinical Trial Support for a First-in-Human Phase I Dose Escalation Oncology Study

Learn how we worked seamlessly with a US based company to deliver efficient and effective full-service clinical trial support for this complex study.

Successfully managing Ongoing and new Oncology studies throughout the COVID-19 Pandemic

Find out how we maintained business continuity, for existing Oncology studies, and initiated new studies with the correct infrastructure, logistics, and digitalization throughout the pandemic.
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Enabling Cancer Clinical Trials with AI/ML technology platform: OneClinical Analytics

Our sought-after AI/ML technology platform, OneClinical Analytics, delivers trial oversight, analytics, and insights, enhancing your clinical trials with insight driven decision making. OneClinical provides near real time data during the trial, which can be used to take proactive corrective action, resolving critical issues at the onset. This will help in intelligent deployment of resources which can save your time and your money.

Regulatory Compliance and Data Privacy Ensured

Designed for, and delivered via, cloud, and in compliance with regulatory and data privacy requirements, our analytics platform enables end to end clinical trial oversight and data analytics services. Proven across a variety of global trials, the platform offers short setup time with low fixed costs, and provides global accessibility with near real-time data analytics and visualizations.

Upto 50% time saved in mapping highly complex studies50%
60% improvement in cycle time to develop initial Interface for data warehouse and 30% cost reduction60%
33% reduction in field monitoring costs through Triggers, Reduced SDV33%
50% reduction in clinical monitoring costs50%
30% reduction in cycle time through process optimization and new technologies (AI, automation, digital)30%

Intelligent and Unified Data Analytics and Aggregation for 5 Clinical Trials, from 3 CROs, and 3 EDC Platforms using OneClinical Analytics

Gain insights about our support for a US-based biopharmaceutical company to unify data analytics and aggregation utilizing OneClinical Analytics to power intelligent study oversight and medical monitoring.