Big pharma demand for adaptive trials growing, says DaVita

The partnership, described by DaVita as a “non-exclusive cooperative collaboration​” will see Ruckle designing trials across a variety of therapeutic areas for DaVita’s clients, with a focus on Phase I studies and subject safety.

‘Changing needs’ ​

“Dr Ruckle will also use his extensive experience in areas such as adaptive trial design, First Time in Man and biologics studies in a consultative fashion with pharma clients,​” spokeswoman Bianca Violante told Outsourcing-Pharma.com.

Clients increasingly want FTIM studies, tests on healthy humans, and patient population studies, said Violante. This research is more complicated and requires a hospital-based clinic and pharmacy facilities.

“These adaptive trial designs are becoming more popular as pharma companies increase their need to get early pharmacokinetic and safety data in a patient population,​” said the spokeswoman.

Ruckle’s “significant medical experience​” in these fields would help the company at a time when it faces the “changing needs of the clinical pharmacology market,​” she added.

Pacific Pharma Group will work on a clinical trial recently awarded to DCR, a “complex cardiovascular safety study in healthy normal volunteers​”, with a currently unnamed sponsor, and several other Phase I investigations, she added. ​

Clinic construction​                       

DaVita Clinical Research is owned by DaVita HealthCare Partners Inc., and carries out clinical trials for more than 150 clients. Its core focus is renal studies, but the company is diversifying to encompass diabetic and cardiovascular patients following a facilities expansion.

DaVita VP, Kevin Goudreau, said “We feel that Dr. Ruckle is a good fit for DaVita Clinical Research because of the nature of our clinical pharmacology offering.​

“We have grown our business to include two hospital-based phase I units, with 122 total beds, as well as all the pharmacometrics​ and medical writing services to support both routine and complex healthy normal volunteer and patient studies.​”

Ruckle said being able to use DCR’s resources would prove valuable to Pacific Pharma Group.

“State-of-the-art, hospital-based Phase I facilities offering access to both patient and healthy normal populations are of great interest to pharmaceutical researchers,​” he said.

“Through our relationship with DCR, Pacific Pharma Group will be able to offer clients access to these valuable services​.”

Ruckle’s work with DCR will be based at its facilities in Lakewood, Colorado, and Minneapolis.