Datatrial Meets the Challenges of Early-Phase Oncology Clinical Trials

At Datatrial, we understand the complexities of your oncology clinical research. We know your clinical trials present unique challenges best met by a boutique clinical data organization with broad oncology experience. That’s why we feel our proven expertise in deploying and managing early-phase oncology trials around the globe will benefit you.

Since we serve as a virtual extension of your team, we understand your specific needs, which allows us to deliver the site support, service excellence and value that best fit your oncology study. And because our collaborative approach has helped us create trusted partnerships, we can identify and implement the best-of-breed solutions that make the most sense for your program.

Our study delivery experts go beyond the technical to meet your clinical needs. Our global teams are expert in designing and deploying oncology studies in our EDC software, nowEDC™ as well as Oracle Clinical. We design your eCRFs or paper CRFs with a very clear understanding of the end users’ requirements as well as the analysis and reporting expectations.

Our teams are experienced in handling the special considerations of oncology trials, including:

• Early Phase: In the majority of Phase I/IIa trials, a significant element of the trial outcomes revolve around dose level. Where patients are entered in cohorts, review of data for safety (dose-limiting toxicities) is essential. Using our simple and well-designed EDC tool with built-in reporting technology expedites the collection of the safety data and enables the safety review committee and dose escalation team to review the data quickly and efficiently. 
• Treatment Schedule: Many oncology trials use standard treatment scheduling within the trial design. This approach requires careful planning within the EDC system to enable easy navigation between cycles of treatment and the ability to collect unscheduled assessments.
• Compassionate Use: If the study drug is showing signs of stabilizing or improving a patient’s outcome, a protocol can often allow compassionate use. During this period, it may be necessary to collect key safety data and disease progression information. This data collection can be easily accommodated within the EDC tool and is included as an expectation at the eCRF design stage.
• Sites: Oncology trials need scalable, flexible systems that can be quickly deployed and supported at a handful or at hundreds of sites across the globe. There is always the option to use paper CRFs to collect data if an oncology site does not have the facility to manage EDC. At sites where recruitment is slow and the site staff is not using the system as much as expected, we can provide support through the Help Desk or via Web-based refresher training. Ideally, we train the CRAs to then support the sites.

The ability to handle these unique considerations makes all the difference in a therapeutic field where only 5 percent of drugs are approved by the FDA and seven out of 10 studies are cancelled in Phase II. And since oncology studies inherently involve very sick patients and complex medications, our built-in flexibility and collaborative approach provides us with the ability to make key in-study changes while maintaining safety, efficacy and validity.

So if you’re looking for an oncology partner that can help reduce stress while delivering results, let Datatrial help you bridge that gap. Contact us to let us know how we can best team with you on your next oncology study.