Clinical Guest Contributors

  1. A Prepared Approach To Technology In Clinical Trials

    Advancements in technology create new avenues for optimizing clinical trials and the lessons that can be learned from them. With the gap between advancements in technology and regulatory uptake in clinical trials, it is important to rigorously examine technology applications. While the promise of new technology can lead to overenthusiastic adoption, mirroring the pace of other industries may not always lead to the best outcomes for patients. To increase regulatory buy-in to the use of these technologies, the clinical trial world needs a thorough understanding of the functionalities of each technical innovation, its potential utility and limitations, and how to build trust among patients, regulators, and other healthcare professionals.

  2. Patient Voice: Determining Fair Market Value For Patient Insights Work

    Clinical research professionals often turn to healthcare professionals to critically assess the complex prioritization and planning of clinical research and to act as surrogates for the patient perspective.

  3. Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  4. Adopting eConsent To Better Patient Experience In Clinical Trials

    Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.

  5. Leveraging AI To Assess Clinical Trial Technologies

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

  6. How Amgen Is Taking An Adaptive Approach To Clinical Trials

    Clinical research is sometimes viewed as a box-checking exercise, where we run fairly cut-and-dried randomized, placebo-controlled studies based on long-established protocols. But things are actually changing very rapidly in the world of clinical development, which is by far the largest part of pharma R&D spending. We are on the threshold of a transformation that will allow us to dramatically accelerate the acquisition of useful knowledge, get new medicines to patients sooner, and expand their usage to new indications more quickly.

  7. What Is Taking So Long For Meaningful Interoperability In Clinical Research?

    Three decades ago when I entered the profession of clinical research, our workplace equipment extended to typewriters, white-out, mimeographs, hand-written documents, rubber erasers, pens, label makers, and fax and copy machines. Rows of massive, locked, fire-proof filing cabinets storing millions of papers for a nationally funded research program lined record rooms, hallways, and every spare corner of the offices. Most of us felt rewarded when we could use a typewriter with a correction key despite one’s typing skills being firmly judged by the illegible mistakes in the carbon copies.

  8. What The Patient Voice Taught Lilly About Clinical Trial Design & Recruitment

    When you’re diagnosed with cancer, diabetes, an autoimmune disorder, chronic pain, a neurological condition such as Alzheimer’s disease, or another illness, having the safest, most effective medicine is paramount. Knowing a promising therapy is “in the pipeline” doesn’t bring you a whole lot of comfort. You want access to the most advanced medicines now.

  9. AI And Blockchain Will Take Center Stage At DIA 2019

    A Q&A with Sudip Parikh, PhD, senior VP and managing director, DIA Americas

  10. How Development Of A Clinical Rating Scale Provided Deeper Insights In A Rare Disease Trial

    In research related to many rare genetic diseases, availability of long-term benchmark data to support the development of accurate assessments is limited. This can have a detrimental effect on new product development. To address this challenge and ensure that clinical development efforts render meaningful results, there is a need to develop outcome measures that assess the entire characteristic clinical phenotype of any given rare genetic condition.