Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential
Dr. Jeffrey Spaeder, Chief Medical and Scientific Officer of Quintiles, told Outsourcing-Pharma.com that access to real-world patient data -- either through partnerships with companies like the electronic health records (EHR) provider AllScripts or national health providers in foreign countries with universal EHRs, like Scotland -- “is an important complement to the trials we do now and can accelerate approval of drugs because it’s an efficient way of investigating certain outcomes.”
Other CROs, such as Icon, have recently set up partnerships with EHR providers to delve more into late stage research data.
Unlike data collected in patient records and reported by patients directly, prospective randomized clinical trials provide data are “dictated to the letter by the protocol [with] no deviation, whereas real world data” provide more heterogeneity, Dr. Spaeder said. He added that it’s important to link together the real world data with the trial data for a more complete overview.
Dr. Spaeder used the examples of cardiovascular and HIV drugs as two therapeutic areas in which scientists are now pulling drug development lessons. In cardiovascular clinical trials, questions were answered sequentially and through small incremental steps, he said. HIV and AIDS trials were boosted by lessons from the cardiovascular community as well as the use of surrogate endpoints to accelerate clinical development.
Biomarkers
The use of biomarkers to stratify patients and “get early reads and outcomes” on a trial is another important factor moving forward in the clinical trials space, Dr. Spaeder said.
“We’ve been a little disappointed that some biomarkers have not had the correlation with the outcomes we would’ve liked, but we needed them for earlier assessments of efficacy and safety and to make go and no go decisions” on whether to proceed with a trial, he noted.
Developments in autoimmune, inflammatory and oncology fields have all benefited from more patient stratification. “Now we have a better understanding of the drivers of a disease,” he said, noting that researchers are “better at stratifying patients, and now increasingly studying patients with significant unmet need.”
Experience as a Driver
Speaking on Quintiles’ recent five-year development deal with Merck Serono, Dr. Spaeder said that the company’s experience running clinical trials is what sets it apart from competitors.
“Quintiles can better balance research needs because we can work with multiple customers,” he said.
“We have a lot of capabilities on a person by person level that are very similar to what pharma companies” offer, he said, noting that increasingly CROs and sponsors are working together “as colleagues rather than as service providers.”
