Featured Trial Design Editorial

  1. Lilly Expects Patient Centricity, Adaptive Trials, And New Technologies To Deliver In 2016

    As the VP of Portfolio Management at Eli Lilly and Company, Anne White spends a good deal of time staying close to clinical trials, patients, and the latest trends affecting them. In her 24 years in pharma, most of them at Lilly, she has served as VP of Oncology Development Operations and Senior Director of Global Strategic Planning and Patient Tailoring. In this Q&A article, White shares her thoughts on pharma becoming more patient-centric and the increasing move towards more adaptive trials.

  2. 2016 Trends: Patient Advocacy, Partnering, And New Technologies Lead The Way

    James Gillespie, CEO of the Center for Healthcare Innovation, believes we are entering a golden era of healthcare, including clinical trials. “There is so much change afoot that this will truly be an exciting time in the U.S. healthcare system,” he says. “But with that change we’ll also see a number of challenges the industry will need to overcome.” In this Q&A article, Gillespie discusses how patient advocacy efforts, new technologies, and partnering models will help shape the future of clinical trials.

  3. WIB Profile: Will Partnering Models Continue To Evolve In 2016?

    I recently spoke to Reichuber about clinical trends we might expect to see in 2016. She feels the industry continues to undergo change in regard to partnering agreements. But are strategic partnerships going away or just evolving? And in what areas do small pharma and biotech firms really need the most help? In this Q&A article, the co-founder and principal of Altani Associates shares her thoughts.

  4. Are Patient Surveys The Missing Link To Successful Recruitment & Retention?

    While patient recruitment and retention have been an issue in the delay and expense of clinical trials for decades, patient centricity has at least temporarily moved to the forefront in the clinical space. Although often discussed as two separate issues, there is no question the two are intertwined. Integrating the patient voice in the protocol design process will certainly lead to better recruitment outcomes and patients who are more willing and able to adhere with a study for its duration.

  5. 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.  

  6. Good Planning And Enrollment Lead To Clinical Success

    When preparing for a clinical trial, many factors can affect the success of your effort. Roger Mills, MD believes two of the biggest factors are proper planning and recruitment. Mills recently retired from the pharmaceutical industry, but before doing so had a long and successful tenure in the industry. His final position was as a clinical lead for Janssen R&D where he was responsible for study activities.

  7. Building A Culture Of Patient Centricity At Sanofi

    Dr. Anne Beal has been involved in the medical community her entire career. After earning a BA in biology, an MD in medicine, and a masters degree in public health, she began her medical career as an attending physician. After spending time working for Harvard Medical School, The Commonwealth Fund, and The Aetna Foundation, she was tapped to be the Deputy Executive Director and COO and Chief Officer for Engagement at the Patient Centered Outcomes Research Institute (PCORI). In April 2014, she was asked to join Sanofi as its Chief Patient Officer. The past year-and-a-half has been a whirlwind of activity for her, defining the meaning of patient centricity and how it applies to pharma, while developing a culture of patient engagement within Sanofi. In this Q&A article, Beal discusses Sanofi’s vision for patient centricity, and getting individuals more engaged with the trial planning process.  

  8. Make QbD A Part Of Your Clinical Trial Process

    The letters QbD (Quality by Design) come up quite often in the pharmaceutical industry. On the manufacturing side of the house, it is an acronym that quality managers live by, for good reason. One quality misstep can mean FDA Warning Letters, supply disruptions, and medicine shortages. If a poor quality product makes its way into the distribution channels, it can also impact the lives of patients. But on the clinical research side of the house, it’s a term you don’t hear too often, even though these studies have a significant impact on patient lives. Coleen Glessner would like to change that mindset.

  9. Clinical Insights: “RBM Is The Biggest Game Changer Since EDC”

    Will risk-based monitoring be the hottest trend to hit clinical trials in years? Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals thinks it will be. “I believe RBM will be the biggest game changer to hit clinical operations since EDC (electronic data capture),” he says. It’s potential to increase quality and lower the time and cost of conducting clinical trials has only just begun to be explored. Think about it, why should we employ a traditional one size fits all monitoring approach when we know that there are good sites and bad sites and that only a small fraction of the total data is changed via source data verification? Resources should be focused on improving the data quality at the problem sites and we now have RBM platforms that are built to identify issues early so we can nip problems in the bud and correct bad habits.”

  10. Lessons Learned From A Venture Into Risk-Based Monitoring

    Last year Trevena decided to undertake its first study incorporating risk-based monitoring (RBM). According to Ruth Ann Subach, director of clinical operations for Trevena, the approach was sexy and trendy and seemed to be what everyone was talking about. But having never done it before, she had a lot to learn. In this article, Subach takes you through the CRO selection process, documents she used throughout the trial, the decision-making process, lessons learned from the study, and the cost savings experienced by her company. Would she do it again? “Absolutely,” says Subach.