Newsletter | November 7, 2022

11.07.22 -- How To Optimize Returns On Plain Language Summaries


Welcome to the Monday edition of the Clinical Leader newsletter, focusing on Clinical Sites, Patient Centricity, and Patient RecruitmentUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Webinar: Sky-High Inflation And The Great Resignation — The Impact On Clinical Site Budgeting

With inflation at its highest rate in four decades and attrition rates at clinical research sites exceeding most industries, developing fair market value (FMV) for investigator grants is more contentious than ever. Join IQVIA Technologies for a topical discussion on budgeting in today’s tumultuous environment.

Click here to learn more.

Patient Recruitment
Janssen And Stand Up To Cancer® Collaborate For Oncology Patient Diversity

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.

The Simple Path To More Diversity In Vaccine Clinical Research

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.

The Case For Patient Diversity In Clinical Trials

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.

NASH And NAFLD Enrollment 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.

Clinical Sites
How Can You Help Sites Manage Training And Education On DCT Technologies?

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.

Advarra Consulting: Global Consulting Powered By Relevant Experience

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

Patient Centricity
How To Optimize Returns On Plain Language Summaries

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.

What Every Clinical Team Should Consider Before The Next Protocol

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.

Building A Flexible, Challenge-Resistant, Patient-Centric Supply Chain

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.

Making Research Better For Patients With Patient Centricity By Design

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