Featured Trial Design Editorial

  1. Improving Study Efficiencies With Protocol Templates For Nonclinical Studies

    Clinical research organizations (CROs) are often required to adhere to a variety of sponsor-specific protocol and/or reporting templates, often presenting the same information in various places or in different ways, depending on sponsor-specific requests. Maintaining multiple templates requires a significant amount of time and resources.

  2. A Rare Disease Trial Requires An Objective Scale And Site Training

    Researchers have known about Angelman syndrome for 50 years. Despite the research that has been done, there is still no treatment option available to patients. Ovid Therapeutics now faces several challenges in bringing a potential treatment through a critical Phase 3 trial.

  3. A Patient’s Journey: Human Interactions Matter In Immunotherapy Trials

    Mary Elizabeth Williams is a journalist and an author. She is also a patient who has with metastatic melanoma who participated in a Phase 1 immunotherapy clinical trial. There is much that pharma can learn from her in terms of how companies approach clinical trials and drug development.

  4. 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.

  5. 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.

  6. Can Virtual Clinical Trials Democratize Medicine?

    There are over a quarter million active clinical trials registered with the FDA right now, up from just 1 percent of that figure at the turn of the century. It's a $65 billion industry – clinical trials alone, that is, and it's only going to get bigger.

  7. Building And Applying A Configurable Clinical Study Model

    Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.

  8. Getting A Handle On Clinical Trial Costs

    Recently, clinical trials have become very complex affairs, especially for small and medium biotech companies. There are many factors behind this, including, but not limited to, increased costs and regulatory requirements. According to Tomasz Sablinski, CEO at Transparency Life Sciences, the cost of clinical trials increased by around 100 percent from 2008 to 2019. A study published in JAMA Internal Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials.

  9. Patient Centricity And Social Media Are Changing Patient Recruitment

    Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Patient recruitment remains a challenge that pharma must work to overcome.  

  10. Alzheimer’s Disease Trials: Where Do We Go From Here?

    The Alzheimer’s disease space is not an easy one for pharma companies to navigate. In 2018 alone, Lundbeck, Takeda, Merck, Janssen, AstraZeneca, and Eli Lilly and Company all faced setbacks or poor trial results. Unfortunately, few spaces in the life sciences have fathered failure to the extent that experimental Alzheimer’s drugs have.