CLINICAL TRIALS ARTICLES

• Increasing Patient Diversity In Clinical Trials

  The COVID-19 pandemic has spotlighted healthcare’s biggest shortfalls. One of the most glaring problems sounds like it should be simple to resolve, but it has actually been challenging to implement — diversity in clinical trials.

• Changing The Status Quo Regarding Diversity In Clinical Trials

  Encouraging patients of all races and genders to enroll in clinical trials has been a challenge for years. So, what can be done?

• Can CROs Rise To The Patient Access & Recruitment Challenge?

  It is not surprising that the task of CRO selection is often stress-inducing. One element we explore in depth is the influence of preferred provider agreements or the lack thereof. We ask clinical development outsourcers about the attributes they focus on under three selection environments.

• The Benefits & Challenges Of Head-To-Head Trials

  In Lilly’s immunology portfolio, eight different H₂H clinical trials have been conducted thus far. Four of those trials were conducted in parallel with a Phase 3 trial and four were conducted after it. Although the benefits are attractive to a sponsor company, H₂H trials can present some unique risks.

• A Quick Transition From Research Firm To Clinical-Phase Biotech

  Since Oct. 2018, Anne Whitaker had to figure out how to transition Aerami Therapeutics from a research firm to a clinical-phase company. It’s been a complicated and challenging journey.

• eConsent In Clinical Trials: Insights For Implementation During COVID-19 And Beyond

  Many sponsors are quickly learning to adapt to the COVID-19 environment by providing virtual tools for clinical trial use. One example of an important tool in this space is eConsent.

• DIA And CRO Leadership Awards Go Virtual

  The team behind DIA’s Annual Meeting was able to put together an event that was as informative and engaging as past years, despite the short and very hectic time frame. More than 200 sessions took place virtually, with 120 of those being on demand.

• 5 Bad Habits The Clinical Trial Community Needs To Break ASAP

  I won’t attempt to address or solve all of the problems that contribute to the high cost of clinical trials, but I will highlight some continuing root causes that I believe persist needlessly.

• 3 Essential Considerations For Running Global Clinical Trials

  In this article we'll look at three key considerations when designing a global clinical trial: selecting the most appropriate trial sites with a representative patient population, choosing to work with the right partners, and ensuring you are up to speed with local regulatory and clinical requirements.

• A Small Biopharma’s View Of Working With CROs

  Running a clinical-stage oncology biopharma with only five employees means you quickly learn a thing or two about the value of outsourcing services. For Pamela Contag, Ph.D., cofounder and CEO of BioEclipse Therapeutics, those learnings have led to her company using five CROs for the company’s lead investigational candidate.