Articles By Ed Miseta

51. Report Reflects Huge Growth of Clinical Trials In China 12/14/2021

    China has been a hot topic in the clinical space for several years, and companies locating clinical trials in the APAC region is now a trending topic in the life sciences. A new report from Global Data shows the degree to which China has been attracting studies.

52. DiMe Reports Significant Growth In Digital Endpoints 12/9/2021

    In October 2019, the Digital Medicine Society (DiMe) launched its crowdsource library of digital endpoints. The library is an open resource that anyone can access. When it launched the library had 34 unique endpoints from 12 sponsor companies. The library has seen significant growth since then. By September 2021 it had 225 unique endpoints from 69 sponsor companies.

53. The State of Real-World Data – And Where We Go From Here 12/7/2021

    There are many questions that a lot of clinical executives have about real-world data (RWD) and real-world evidence. There are questions about the quality and completeness of the data, the new digital apps generating data, patient privacy, its use in synthetic control arms, and the impact it might have on the patient diversity problem.

54. One Year In, DTRA Meets Goals & Looks To The Future 12/1/2021

    In November 2021, the Decentralized Trial & Research Alliance (DTRA) held its annual meeting in Boston. The DTRA was formed in 2020 with more than 70 founding members from pharma companies and their technology and service partners. I took this opportunity to speak with Craig Lipset, DTRA’s co-chair, about the progress the organization has made and its vision for the future.

55. Why Every Biotech Needs Qualified Drug Hunters 11/29/2021

    Christopher Kirk, co-founder, president, and CSO of Kezar Life Sciences, believes every biotech needs a good drug hunter. “This is an industry that is rife with failure,” says Kirk. “Every failure will cost companies a lot of time and money. Every company needs their scientists focused on meaningful drug discovery research with the goal of reducing this failure rate.”

56. A Lesson Learned From Big Pharma: Don't Be Afraid To Go Global 11/19/2021

    The rheumatic diseases Kezar Life Sciences is attempting to treat have racial disparities across the world that create different outcomes and incidence rates of autoimmune disorders. Those considerations must come into play when thinking about trial design. The company has learned you should not be afraid to go global as early as possible.

57. Clinical Trials Enter A New Digital Era 11/17/2021

    The life sciences industry has been undergoing a transformation. Its seen advancements in how therapies are developed and improvements in how the industry works together. One development that has helped the industry evolve is the shift to digital technologies.

58. Hybrid Trials Are Impacting Clinical Research, But Do Patients Want Them? 11/11/2021

    Clinical trials continue to evolve and have become increasingly complex. Studies now have more procedures, visits, and time spent at clinics during those visits. The Center for Information and Study on Clinical Research Participation (CISCRP) is celebrating its eighth year of focusing on the patient experience in clinical trials via its Perceptions and Insights study.

59. 4 Factors Preventing Diversity In Trials – And How To Overcome Them 11/9/2021

    A study conducted by advocacy group For The Breast of Us along with Sommer Consulting sought to determine the factors keeping women of color from participating in breast cancer clinical trials. Founded in 2019, For The Breast of Us is the first online community dedicated to women of color affected by breast cancer.

60. Report: Hybrid Clinical Trials Are Here To Stay 11/4/2021

    ISR Reports has released a new report titled Hybrid/Virtual/Decentralized Clinical Trials Market Outlook. The report looks at the adoption of these trials and the components that are gaining the most traction.