CLINICAL TRIALS ARTICLES

• A Small Biopharma That Doesn’t Use CROs

  When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. That is what makes Martin Lehr, CEO of Context Therapeutics different. He prefers to bypass CROs and take part in Investigator-Sponsored Trials (ISTs).

• Biotechs Will Make Music In The “Twenty-Twenties”

  Outsourced Pharma Chief Editor Louis Garguilo talks with two biotech CEOs about why they believe this industry should expect an infusion of technology and improved productivity in the coming years.

• Patient Diversity Starts With Community Connections

  When it comes to clinical trials, the pharmaceutical industry still has a patient diversity problem. The face of patients in clinical trials is not representative of the face of America.

• Comparative Biosimilar Clinical Trials: More Questions Than Answers?

  As one expert said, though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.

• The Importance Of Pursuing Clinical Trial Costs

  As clinical trials become more complex in terms of regulatory compliance and scope of study, it is more important than ever that procurement teams develop a clear understanding of the various cost drivers related to operating a clinical trial.

• Success In HIV Treatments Creates Additional Challenges For Drug Developers

  HIV drug developers have a whole new set of challenges, including making the regimens simpler better tolerated. In addition, since today’s patients can access these medicines through pharmacies, they no longer have the incentive to take part in clinical studies.

• Regeneron Manages Clinical Costs In A Fast-Growing Organization

  Bari Kowal, VP and head of global clinical operations at Regeneron, says sponsors and CROs must partner to make clinical trial execution more efficient and cost-effective.

• AbbVie Goes All-In On Wearables And Digital Technologies

  Three years ago, AbbVie decided to stop talking about using digital technologies in clinical trials and start actually using them. The company then began deploying wearables in three clinical trials.

• The Honest Truth About Enrollment, And What You Can Do About It

  Insights for the simple things you can do to mitigate the most common patient enrollment problems that every study (with very few exceptions) will inevitably face.

• Master Trial Protocols: Better For Pharma, Better For Sites

  The primary benefit of master trial protocols for drug companies is the ability to concurrently evaluate multiple studies that may have different objectives, saving both time and money.