From Preferred Provider to Strategic Partner
When a pharmaceutical company recently needed to conduct two full-service studies as part of their large oncology program, INC Research’s global site relationships, therapeutic know-how and regulatory expertise made us an ideal partner. In fact, the customer was so pleased with our execution, that shortly after awarding us the studies INC Research was selected as a preferred provider and expanded our remit to include five prostate cancer studies, involving around 800 patients across 165 sites in 14 countries.
As our relationship matured from preferred provider to strategic partner, training was provided to project management personnel within INC Research and the customer’s organization to harmonize communication, preferences and expectations and ensure that everyone was working toward the same goals. In addition, steering and governance committees were established to guide the teams. Through this relationship, we have been able to deliver a number of value-added benefits for this customer, including task and time efficiencies, faster study start-up procedures and consistent project staffing with whole project teams rolling from one project to the next bringing significant cost savings.
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Turning Around a Large Combination Study
INC Research delivered the largest trial ever conducted of combination therapies for the treatment of oncology patients with severe chemotherapy-induced nausea and vomiting. The trial, for a privately owned European healthcare company, comprised five multinational full-service Phase III studies. The goal was to recruit more than 2,800 patients at more than 350 sites worldwide, but it was a complex undertaking and site recruitment initially was slow.
INC Research’s solution was to provide executive oversight and enhanced project leadership to ensure all expectations were met or exceeded. We used our experience to speed site and patient recruitment by adding regions and countries rich in qualified investigative sites and patient populations that met the study criteria (e.g., Mexico and Russia). Additionally, our Regulatory Affairs group provided support in the assembly and filing of the New Drug Application (NDA) in the United States. The New Chemical Entity (NCE) gained FDA approval in 297 days, the fastest out of 12 products undergoing a standard review procedure in that year − a true measure of our ability to turn around a slow study start up.
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Prostate Cancer Study
In a prostate cancer study, INC Research’s Oncology team was able to complete recruitment of 140 patients within 3 months versus 5 months. Through proactive project management and the use of a variety of creative recruitment strategies during the ProgramAccelerate phase of our Trusted Process, our project team shaved two months off the recruitment timeline, despite two protocol amendments and over one-third of the sites used being academic in nature.
Although most oncology/hematology Phase I trials share the same challenges and follow familiar designs, the conduct of each and every study may bear pitfalls, complex issues, first-in-man curiosity, and/or relatively new targets. These all require intensive yet clear communication and careful consideration for all stakeholders (sponsor, investigators). At INC Research, setting clear expectations, managing teams and partners, and the use of real-time data are all ingredients of our data-driven operational mindset. With our extensive global reach, we can deliver the services clients need, even at the Phase I stage, regardless of sponsor and investigational site locations.
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Innovation in Phase I Studies
INC Research was asked to deliver a full-service Phase I study to determine the maximum tolerated dose of a biological compound for solid tumors, including renal cell cancer. The compound under investigation was a variant of one already on the market, which had significant toxicity. The new compound had been designed specifically to target tumors more efficiently, thus improving the safety profile.
INC Research utilized two sites to deliver this study, including a dedicated unit at the European Centre for Oncology in Milan. We appointed a local Project Manager and Lead Monitor in Milan to ensure effective communication among all key contacts during the year-long study, which included medical monitoring, project management, data management, statistical analysis and medical writing. One of our investigators for the study, a radiologist, was keen to use Positron Emission Tomography (PET) scanning for assessments, an unusual request for a Phase I study. We were able to obtain a protocol amendment on PET scanning as this was not yet established by the regulatory authorities.
The result? We completed our recruitment objective of the target 22 patients and delivered the study on time.
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Phase IIIb Global Study
INC Research performed project management and data management services for a Phase IIIb study conducted in 52 countries, with study sites recruiting 8,000 patients. The challenge in this study was to blend client-driven clinical monitoring with INC Research services, thus operating as service provider for client’s headquarters, as well as the dedicated liaison for all 40 involved international affiliates and partners.
INC Research successfully maintained relationships with all stakeholders in a “lean-and-mean” Phase IIIb operational setting. Notably, during conduct of this study and its QualityFinish, the accrued data has served scientific needs while also increasing marketing information both from the client’s headquarters’ point of view and from a local affiliate perspective.
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Phase II Hematology Study
A Phase II study that initially started as a pilot AML/MDS study with a few dozen patients, evolved from a 2nd tier supportive study into a pivotal Phase II study. Through the ProgramAccelerate phase of our Trusted Process, we recruited over 160 patients across sites in North America and Europe. INC Research was flexible to the client’s needs and provided proactive study management that helped drive study evolution while providing the continuous study updates required by the client.
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Case Studies
Oncology: From Preferred Provider to Strategic Partner
Oncology: Turning Around a Large Combination Study
Oncology: Prostate Cancer Study
Oncology: Innovation in Phase I Studies
Oncology: Phase IIIb Global Study
Oncology: Phase II Hematology Study
Leadership
Alistair Macdonald
General Manager & EVP, Oncology
Nicholas Kenny, PhD
Executive Vice President, Oncology
Chris Smyth, PhD, MBA
Senior Vice President, Oncology
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