Durham, NC: November 19, 2012
Durham, North Carolina—November 14, 2012. Health Decisions, Inc., the clinical research organization setting the standard for efficiency in clinical trials, today announced the launch of a personalized medicine initiative.
“Traditional clinical development methods are too costly for blockbuster drugs that target millions of patients, let alone the much smaller population for a treatment suitable only for people with a particular set of genes,” stated Health Decisions’ CEO Michael Rosenberg, MD, MPH. “Our personalized medicine initiative is focused on more efficient approaches that can address the challenging economics of drugs for smaller populations.”
As an example, Rosenberg cited an innovative pilot study that Health Decisions is conducting to accelerate development of a treatment of a respiratory indication. The study is based on so-called “N-of-1” methodology.
“N-of-1 studies provide an efficient alternative to conventional early-phase studies and enable pharma and biotech companies to acquire knowledge about novel medicines faster and at lower cost,” Dr. Rosenberg said. “Rather than treating all patients in one dosing cohort or treatment arm the same way, these studies apply lessons from the treatment of each individual patient to treatment of each subsequent patient. The result is continuous learning that dramatically shortens time required to evaluate a drug.”
“Conducting an N-of-1 pilot study requires immediate, actionable data, something few companies can provide,” Dr. Rosenberg said. Our data capture technology allows us to receive data from the field almost immediately. “The Health Decisions SmartPen™ allows staff at investigational sites to enter data by hand as they interact with subjects. Capturing data in electronic form in the first place rather than transcribing from paper provides a leap in efficiency. Because we are capturing electronic data as source data, we don’t need to send a clinical monitor out to the site to compare electronic data with a paper source document. The sponsor gets more accurate data, gets it faster and benefits from lower monitoring costs as well.”
Dr. Rosenberg said achieving greater efficiency in clinical development also requires innovative techniques for site monitoring. “We can do a lot of site monitoring remotely,” Dr. Rosenberg stated.
By applying adaptive monitoring techniques, we can ensure data quality in a much more cost-effective way.” Adaptive monitoring adjusts monitoring activities based on predetermined Acceptable Quality Levels (AQLs) for each type of data. “We track actual data quality vs. AQLs and provide more intensive monitoring if we need to bring quality up. For some types of noncritical data, we can also monitor less intensively if data quality exceeds targets. This can provide big savings in both time and cost.”
“The ability to execute N-of-1 trials and perform remote monitoring and adaptive monitoring are a few examples of how operational and technological excellence enables us to reduce costs and timelines and make personalized medicines economically viable,” Dr. Rosenberg said.
About Health Decisions
Health Decisions (www.healthdec.com), a global clinical research organization (CRO), leads the industry in trial efficiency. Through integrated technology and agile clinical development methods that apply adaptive principles to both trial design and operations, Health Decisions provides sponsors unprecedented transparency and control and produces results 10-40 percent faster than traditional approaches.
Health Decisions is headquartered in Durham, NC, with over twenty years of drug development experience in setting new standards of speed and accuracy for pharmaceutical, biotech and medical device companies in Phase I-IV trials across all major therapy areas. For more information, please visit the company’s website atwww.healthdec.com.