Our Knowledge Is Your Gain

Recent scientific advances have both enlightened and complicated oncology clinical research. Key among them is the heterogeneity of tumors at the same primary site. The ensuing necessity for companion diagnostics to identify which patients will benefit from a targeted therapy and for rapid identification of molecules that can sidestep acquired resistance, plus progress in immunologic- and vaccine-based treatments, have increased the complexity of drug development. At Worldwide Clinical Trials, our core oncology expertise means your trial starts from a favorable, advanced position. Our commitment to your study objectives and our ability to proactively identify and overcome operational challenges mitigate your risk.

Worldwide Is Your Translational Research Partner:

How does Worldwide differ from other contract research organizations (CROs) you may be considering? You want to bridge the gap between basic research and the production of agents that benefit patients. Worldwide offers experience in:

  • Implementing traditional and accelerated dose escalation designs and sequential trial designs that deliver innovation and efficiencies in phase I and phase I/II studies
  • Facilitating gene-expression profiling in exploratory studies designed to identify patients for whom molecularly targeted therapies may be efficacious
  • Producing adaptive study designs that permit modification of a trial’s course based on accumulating results, potentially allowing much smaller and more focused oncology trials1
  • Working with targeted therapies featuring innovative biological properties
  • Executing complex, multi-part designs in later-phase trials

Additionally, we can collaborate on “basket studies,” which enroll patients with a particular mutation regardless of their cancer type.2

Directing the Approach:

Whether your new targeted therapy or immunotherapy is first tested in volunteers or in cancer patients, Worldwide can lead from the start of your program through preparation and submission of core documentation to regulators. For example, we strongly advocate scheduling pre-Investigational New Drug (IND) meetings with the FDA (or obtaining scientific advice from the European Medicines Agency) to test the response to your drug-development strategy. Early interaction is particularly desirable when the proposed clinical development program incorporates innovative trial methodology or evaluates a compound considered first-in-class for a given tumor. Additionally, Worldwide is establishing master confidential disclosure agreements with premier oncology phase-I units in the US, Europe, and Singapore that offer access to virtually all types of cancer patients. The US unit enrolls approximately 1000 oncology patients in phase I trials every year. Tumor tissue at this location is minimally screened against a panel of 50 mutations/markers, with the capability of testing >400, depending on drug target. All of the units offer assessment of your inclusion and exclusion criteria, for alignment with the available patient population and likelihood of efficient enrollment.

Worldwide can advise on the nuances in combined phase I/II study conduct (ie, determination of maximum tolerated dose [MTD] or biologically effective dose [BED], followed by population expansion for safety assessment and, potentially, signals of efficacy). Combining phases can minimize risks to patients and allow faster development. In our experience, use of 3–4 sites is ideal for MTD/BED determination. We then rapidly recruit to efficiently transition from phase I to phase II, and in the process shift the focus of clinical evaluation to patients with a single tumor type contingent upon emerging efficacy and safety signals.

Driving Geographic Success:

As oncology drug development has gathered pace and more new molecules fill the research pipeline, competition for investigators and patients has intensified, impacting timelines and inflating trial costs. Worldwide clients benefit from our operational capabilities in emerging regions such as the Middle East and North Africa, where competition is lower and patient access is less encumbered. Our capabilities also fully extend to regions such as the Asia-Pacific, Russian Federation and Central/Eastern Europe where the centralized healthcare system promotes efficiencies in study execution by establishing large referral networks for recognized centers of excellence.

We understand that in-depth knowledge of local standards of care and regional variations in oncology practice can materially impact a site’s ability to actively enroll in a proposed program. Our extensive experience with local cultural, medical, and regulatory environments translates into reliable intelligence about territories to access as well as those to avoid, which results in the delivery of valuable data vital to successful oncology clinical research.

Delivering Experience:

Since 2008, Worldwide has conducted more than 80 oncology trials under using advanced project management, site management and monitoring and other services as well.

Worldwide has orchestrated phase I–IV interventional and observational studies in solid tumors, hematologic malignancies, and supportive care. Our oncology team is supported by a global network of experienced clinical sites with detailed knowledge of oncology studies. Partner with us for strategic therapy development.

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For example, see Ivanova A, Murphy M. An adaptive first-in-man dose escalation study of NGX267: Statistical, clinical, and operational considerations. J Biopharm Stat. 2009; 19: 247-255.
Various studies are underway to test the efficacy of this approach, including the National Cancer Institute’s Molecular Analysis for Therapy Choice (MATCH) Program, in which approximately 1000 patients will be assigned to phase II trials (each N=30) and treated with 1 of 20−25 drugs that target the genetic abnormalities being tested for in this study. Patients whose cancers progress during the first assigned treatment may be able to join another MATCH trial arm if they have a second actionable molecular target in their tumors. The success of the basket trial design depends on collaboration among pharmaceutical companies. In preliminary comments, the FDA has indicated it could approve drugs with basket-study data alone.