Posts Tagged ‘clinical trials’



Technology Access Could Lower Barriers to Clinical Trial Acceptance

August 13th, 2013
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“Research is to see what everybody else has seen, and to think what nobody else has thought.” Nobel Laureate Albert Szent-Gyorgyi no doubt would be impressed with the modern pace of medical research, but possibly concerned that we need to think about clinical trials in ways nobody else has.
 
Only 3% of people with cancer enroll in a Phase I trial, but 72% of all Americans say they would gladly volunteer on the advice of their doctor. Social media and internet tools have tremendous potential for increasing volunteer enrollment in clinical trials, but many barriers still exist. The factors keeping potential trial volunteers away have been consistent over the years: unease with trial settings, randomization and placebos; lack of understanding or discomfort with the research process; fear of drug side effects and trial protocol rules/requirements; as well as lack of awareness, a perception that trials aren’t appropriate for serious disease, and hesitation among physicians to make recommendations. Read the rest of this entry »

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Clinical Trials Could Get More Participant “Likes” from Social Media

July 19th, 2013
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A few months ago, I discussed the development of a patient-centered clinical trial, in which participants could access their own health data and even help design more personalized clinical testing protocols. Much of this activity would happen online, which begs the next question: can the online patient-centered trial model be used to drive more people to volunteer for trials?
 
Recruiting enough participants has long been a significant challenge for clinical trial coordinators. Poor site selection and slow recruitment are the biggest reasons for clinical trial delays (which in turn, are the biggest reasons for slower drug approvals). As of 2010, it took 6.8 years on average to complete the clinical trials component of a drug’s development, out of 8.3 years to finish the entire cycle from IND to NDA. On average, recruitment delays add 4.6 months to the clinical trial process—on top of all the other factors that delay trials, this is one we can control.
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Patient-centered trials: Can they boost participation AND empower patients?

April 18th, 2013
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The traditional clinical trial (which, by the way, has been a “tradition” for only about 30 years) involves recruiting a number of people who are required to come to a site on a regular basis to participate. After the trial is over, the trial participant receives payment (sometimes) and not much else. Rarely, if ever, are results or data shared with participants.
 
This model is starting to show some cracks (particularly for U.S.-based trials), however, as recruitment becomes more challenging, and regulatory and liability issues require larger and more complex trial structures. But our era of the Internet, greater consumer power and a trajectory towards tailored, “precision” medicine could provide an answer: more personalized, patient-centered clinical trials. And the trials are more than just a lure for volunteers; they can change how medical research is conducted, all the way down to the results.
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For Clinical Trials, Digital is the Way to Go

March 25th, 2013
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Review any drug’s development history: Clearly, the execution of clinical trials makes up the lion’s share of the timeline. To further complicate matters and extend development timelines, as more drugs are being developed on a global basis, it’s more difficult to keep a clinical trial on target with multiple sites around the world, site qualification visits, and record keeping. In fact, 80% of today’s clinical trials fail to meet one or more milestones. Fortunately, digital technologies – increasingly being adopted by contract research organizations (CROs) and larger biopharmaceutical companies – may offer a way around the limitations of today’s paper-based practices.
 
Recently, Johnson & Johnson, Merck & Co. and Eli Lilly & Co. announced their plans to create a database of global clinical trial sites, which would streamline any participating trial’s significant paperwork requirements. The database would contain site and experimental infrastructure details, and good clinical practice GCP records. The partners will be presenting their progress at the Partnerships in Clinical Trials meeting in April.
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Negative Headlines, Scientific Vulnerability and the Future of Genetic Tests

July 19th, 2011
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Though the life sciences industry is making great progress with genetic tests and targeted therapies, a recent article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”) exposes disturbing and cautionary insights into the application of this technology. The article revealed that research on the application of complex genetic tests to match cancer patients to the best available therapy may not be as promising as it seems.
 
The article describes a situation that emerged just over a year ago that raised serious doubts about a test developed by researchers at Duke University. The test used gene expression signatures to characterize tumors and to identify those most likely to respond to different drugs.
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