Clinical Trial Technology Editorial

  1. Quintiles Chairman Reflects On 33 Years In Drug Development

    On December 31, 2015 Dennis Gillings will officially step down as the Executive Chairman of Quintiles. When Gillings began working with pharma companies in 1974, shortly after coming to the U.S. from England, he was a professor of biostatistics at the University of North Carolina at Chapel Hill. His career in pharma started when he received a call from Hoechst, which later became Aventis and, subsequently, Sanofi

  2. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For November 2015

    Below are my top three articles downloaded on Clinical Leader for the month of November 2015. In case you missed them, please take this opportunity to see what everyone else was learning about electronic health records, patient centricity, and planning for clinical success. 

  3. Risk-Based Monitoring: Understand It Before You Implement It

    Duncan Hall, CEO Triumph Research Intelligence (TRI) and Triumph Consultancy Services, is dedicated to helping CROs and pharma firms align their core business processes with the latest technologies. Obviously a lot of his time is currently spent helping clients navigate the difficulties of implementing a proper RBM (risk-based monitoring) plan. Installing the technology is not difficult, but making sure the solution you select properly aligns with your needs can be a challenge.  

  4. Why The Cloud Is Set To Ignite A Clinical Trial Revolution

    Clinical research is transforming from a paper-driven model into one that is almost wholly electronic. This goes well beyond the electronic transcribing of data. Wearables and smart phone technology now make it possible to electronically collect data directly from clinical research trial participants, skipping many manual and middle steps.

  5. Are We Moving From Strategic Partnerships Back To FSP Relationships?

    What changes can you expect to see in clinical trials going into 2016? George Betts, Senior Director of Medical and Regulatory Affairs for Ipsen Biopharmaceuticals, believes patient recruitment and technology will continue to be a focus for sponsors going forward. He also believes that the specialty CRO market place will continue to grow as many sponsors move away from strategic partnering and go back to FSP relationships with smaller, specialty CROs.

  6. Can Electronic Health Records Bring Down Drug Prices?

    Protocol development is a difficult task, even with the experts we have in pharma companies and clinics. One way of measuring the quality of those protocols is looking at the number of protocol amendments pharma companies generate. These are generally due to a protocol being too complex, or the criteria being too strict. Generally, the end result is not enough patients enrolled in the study on time. One solution to that problem might be the reuse of electronic health records (EHRs).

  7. Does Pharma Really Want Transparency In Clinical Trials?

    My recent article on transparency in clinical trials, featuring Dr. Brad Thompson, CEO of Oncolytics, solicited a good number of comments and emails from readers. While most readers agree that more transparency would be good for patients and the industry, there seems to be a lot of disagreement over how it can be achieved, and if it can actually be achieved at all. 

  8. WIB Profile: Embrace Change Management Or Expect To Fail

    Risk management is a concern for all pharma companies, and the increasing rate of adoption of new approaches, such as risk-based monitoring, will keep it a concern for years to come. Of course with any new approach comes the resistance to change from employees and managers who don’t trust the new approach, feel it will make their jobs more difficult, or even worse, eliminate their jobs altogether.

    Change management can be one of the most difficult tasks for pharma executives to oversee. Consultant Angie Maurer’s job is to help them manage it more effectively. “It seems to take executives and personnel in the pharma industry a long time to accept, adapt, and deal with change within their organizations,” she says. “Everyone knows the pharma industry tends to be rather conservative, and that is as true today as it has always been.”   

  9. Is Impacting Study Results?

    Could forcing companies to report their trial methods and outcome measures prior to conducting a study actually impact trial results? According to a study conducted by PLoS ONE, the launch of the government website does seem to have had an impact on trial results. In a sample of 55 trials testing treatments for heart disease, 57 percent of the studies conducted prior to 2000 reported positive results from the treatments. In studies that were conducted after 2000, the studies reporting a positive result fell to only 8 percent. The difference is shocking, and naturally led to many questioning the possible role of the website.

  10. Clinical Insights: Progress Being Made With Mobile Technologies

    In this second part of my interview with Zaher El-Assi, president of Merge Healthcare’s eClinical division, he discusses the status of mobile technologies and wearable devices in clinical studies and the promise they hold for transforming trials via their application to Big Data.