Articles By Ed Miseta
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How To Operationalize Diversity In Clinical Trials
5/31/2022
Changes are quickly taking place regarding the push for patient diversity in clinical trials. For years, sponsor companies have been trying to increase the number of ethnic and diverse patients in their studies. Soon, they will face tougher oversight. Here is how one company is overcoming the challenge.
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Igniting Innovation Through Global Collaboration: DIA 2022
5/17/2022
DIA's Global Annual Meeting is the largest gathering of regulators, industry experts, healthcare practitioners, life science researchers, and patients. This June, DIA will bring this community to Chicago for an in-person meeting which promises to be a celebration and reunion.
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Is Janssen's Pathway Approach The Future Of Drug Development?
4/25/2022
The last 20 years have provided Janssen with insights that are evolving how it thinks about disease. The company has learned that the molecular underpinnings of disease offer a new way of classifying disease. Janssen now has more of a molecular or taxonomic way of looking at disease and the molecular pathways that are dysfunctional, especially in immune-mediated diseases that cut across many different organ systems.
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Developing A Plan For Patient Diversity? The FDA Shares Advice
4/25/2022
The FDA has released a draft guidance discussing patient diversity. The guidance recommends that sponsor companies include a plan to increase diversity in the clinical trial designs they propose to the agency.
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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.
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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.
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How Can Pharma Build Trust In Connected Sensors?
3/9/2022
The growth in the use of connected sensors in clinical trials has been nothing short of astounding. An estimated 275 million wearables shipped globally in 2021 and that number is projected to double in the next four to five years. For the use of sensors to continue to grow in clinical trials, pharma will need to develop more trust in them.
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Is A Preferred Provider Agreement Right For You?
1/14/2022
A preferred provider and/or a strategic provider is a vendor company, often a CRO or other specialty service provider, that has achieved priority status in the awarding of contracts by pharma/biotech companies. With the growing complexity of clinical research, the preferred provider is gaining popularity with many companies. Clinical Leader's Chief Editor, Ed Miseta, talks with Jennifer Johnson of UCB in this Q&A.
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Is Janssen’s Pathway Approach The Future Of Drug Development?
1/6/2022
Two Janssen execs talk about the future of what they call a pathway approach to developing new medicines, which attempts to match the biology of a pathway to unmet medical need for patients, across a broad range of immune-mediated, inflammatory disease.
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Trends To Watch In 2022: RWD, DCTs, And Cell & Gene Trials
12/16/2021
As we prepare to close out 2021 and look ahead to 2022, it’s a good time to think about the trends that will impact clinical trials in the new year. At this time of year, I receive numerous emails from companies outlining predictions for the coming year from some of their executives. Here are a few I'd like to share.