11.07.22 -- How To Optimize Returns On Plain Language Summaries

In June 2022, Stand Up To Cancer (SU2C) announced sponsorship of an initiative with the Janssen Pharmaceutical Companies of Johnson & Johnson to increase the participation of patients from medically underserved communities in oncology early-phase clinical trials.

Learn how increasing diversity in vaccine clinical trials can improve vaccination rates among minorities, who often lack trust in vaccine safety or are undereducated about vaccines.

When the FDA issued a challenge to a sponsor to increase patient diversity in a hepatitis trial by 15%, it meant a significant increase over the sponsor’s previous study. Read how the head of global operations met the challenge with a multi-tiered approach that took advantage of one of the company’s key technology solutions.

Providing easy-to-access educational materials that guide patients through all relevant parts of their potential journey not only promotes patient comprehension, it also facilitates successful clinical trials.

When the COVID-19 pandemic hit the U.S. in March 2020, many drug developers were caught by surprise. With clinics overwhelmed by COVID-19 patients and the reluctance of some patients to venture out to those clinics, many trials faced the prospect of being delayed or canceled. Decentralized clinical trials (DCTs) and hybrid trials, which can take studies from the clinics to the patients, seemed to be the solution to keep things on track.

Solve mission-critical challenges and bring life-changing therapies to patients faster with Advarra Consulting.

The EMA now requires plain language summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

Even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience: clinical trial participants.

Flexible solutions such as demand-led supply and direct-to-patient distribution are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.

Discover why many sponsors struggle to design and conduct studies that accommodate the perspectives and preferences of patients and caregivers.