Real-World Data / Real-Word Evidence Insights

51. Digital Solutions, Technology, And Patient Care Top Life Science Trends 9/6/2022

    Technology company Within3 has produced a paper on the six top trends that are going to impact the pharmaceutical space. It’s no surprise that technology solutions were one of the trends making the list, but also included were factors such as patients, cyber threats, and a growing global marketplace.

52. Combining Data Science & RWE For Better Clinical Outcomes For Immunological Diseases 8/15/2022

    As we continue to better understand immune-mediated inflammatory diseases, Janssen is applying machine learning and artificial intelligence to real-world data to generate real-world evidence (RWE). This RWE gives us a deeper awareness of patient needs, gaps in current treatment options, and a vision toward new areas of research. 

53. CVS Health Wants To Be Your New Clinical Research Site 7/6/2022

    CVS has been a well-regarded and recognized healthcare brand that started as a pharmacy but has since migrated into a recognized and trusted healthcare company. Now CVS is hoping to expand the relationship it has with patients by moving closer into primary care and clinical trials.

54. RWD/RWE: To Replicate Or Continue To Learn In The Real World? 6/23/2022

    In addition to using real-world evidence (RWE) for clinical- and cost-effectiveness, it is also now being used for regulatory reviews of safety, efficacy, and quality. This article covers different types of decision-making using RWD/RWE across pharma companies, healthcare providers (HCPs), healthcare systems, payers and health technology assessment (HTA) agencies, regulators, and patients.

55. What Does The Future Hold For Decentralized Clinical Trials? 4/20/2022

    What can we expect to see from decentralized trials in the next three years, and what are the challenges sponsor companies will need to overcome? A webinar hosted by IBM Watson hoped to answer that question and many others.

56. 4 Pitfalls To Avoid With RWE For Regulatory Submissions 4/19/2022

    Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

57. The Next Three Years Of Clinical Trials: DCTs, RWE, And Beyond 4/18/2022

    Recent years have seen unprecedented innovation in the clinical space. Precision medicine, cell and gene therapies, decentralized trials, real-world data, and the promise of artificial intelligence (AI) and machine learning (ML) are just a few of the reasons to be excited about the future of clinical research.

58. How Can I Use Real-World Data In Clinical Trials? 3/29/2022

    Real-world data (RWD) and real-world evidence (RWE) can be relevant and essential to bringing innovation to patients and gaining regulatory approval. This article describes the sources of real-world data, how to use real-world data to enhance a development program, and how RWD and RWE advance regulatory decision-making.

59. How Our Foundation Is Advancing The Use Of Real-World Evidence In Cancer Research 2/24/2022

    The pandemic has sped up the widespread use of real-world evidence (RWE). It is being used to inform the development of new drugs and medical products, and it helps inform about patients’ treatment journeys. Challenges remain in assuring the quality of the real-world data that is collected and the opportunity for long-term follow-up for participating patients, but those are challenges that can be overcome with the right tools and support.

60. FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products 1/19/2022

    The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.