Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 Purple DNA Strandimmuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times article: A Cancer Conundrum: Too Many Drug Trials, Too Few Patients. Another piece of the puzzle is clinical trial design, which can be especially elaborate when testing combination treatments in IO. Exacerbating these issues, IO trials are an increasingly competitive race to market. There is great value assigned to reducing development times and being the first drug approved within a class or for a specific indication.

This blog article discusses the current state of immuno-oncology studies, strategies for enhancing patient recruitment, the role of companion diagnostics and solutions for dealing with the complexity of IO combination studies. Continue reading

Leveraging Real-World Patient Data to Support Recruitment in Diabetic Kidney Disease Studies

Practicing physicians frequently obtain laboratory assessments of kidney function in their routine management of patients with diabetes. Two tests that are commonly performed are the estimated glomerular filtration rate (eGFR) and the urinary albumin toDiabetic Kidney Disease Studies creatinine ratio (ACR). Results of these tests are often used to determine patient eligibility for clinical trials of drugs to treat patients with diabetic kidney disease (DKD).

One challenge that drug developers and clinical trialists face is in choosing eGFR and ACR criteria that support the aims of the clinical study—without hindering recruitment.

To address this issue, researchers at Covance and LabCorp queried a LabCorp database of 329,841 diabetic patients to analyze real-world data. They wanted to understand the distribution of eGFR and ACR values among diabetic patients in the United States and assess how these laboratory parameters predicted renal disease progression.

Continue reading

Maximize Phase I Study Timelines through Innovative Clinical Trial Design

karen-cEarly clinical research continues to be a high stakes industry requiring increasingly complex studies, procedures, and protocol designs all of which take longer to complete, which in turn drives up cost. The introduction of combined protocol designs—also called umbrella protocols—is gaining popularity among drug developers as a way to bring the first subject visit for the all-important proof-of-concept study forward by months, as well as saving significant cost.

Continue reading