Newsletter | March 11, 2020

03.11.20 -- Patient Diversity Starts With Community Connections

  Webinar: Central And Bioanalytical Lab Market Dynamics And Service Provider Performance

On March 12, at 1:00 PM EST, ISR will review findings from two recent pieces of market research. One details the evaluations of central lab service providers on key performance measures. The other offers insight into the bioanalytical lab market to help both sponsors and providers stay current with market dynamics and anticipate changes that may be coming down the pike. Register here.

Featured Editorial
Patient Diversity Starts With Community Connections
By Ed Miseta, chief editor, Clinical Leader

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 or the individuals projected to be most in need of the medications being developed.

The Journey To Get An Ovarian Cancer T-Cell Therapy Into Clinical Trials
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)

Daniel J. Powell Jr., Ph.D., and his research team at the University of Pennsylvania, has launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.

Industry Insights
Revised Common Rule Compliance Now In Full Effect: What That Means
Article | By Stephanie Pyle, Advarra

How does the revised Common Rule affect your research? On January 20, 2020, we reached the final compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”). Get the facts here!

A More Complete Scope For Advances In Women’s Health
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

The field of medicine pertaining to women’s health is rapidly growing to include the study of both specific conditions that only manifest in women and also maintenance of well-being and quality of life during the unique but normal life cycles experienced by women. Fortunately, we are beginning to understand the implications of women-specific needs on mental and emotional health, and new devices are being designed to cater to these needs.

Actigraphy For PTSD
Case Study | By Krishna Jhaveri, M.D., Ph.D., Philips Respironics

The relationship between PTSD and sleep disruption is complex. Sleep patterns of those with PTSD likely fluctuate over time depending on the chronicity of PTSD, the nature of trauma, comorbid conditions, and medication usage. Actigraphy is thus ideally suited to studying these patterns as it is precise, noninvasive, objective, and provides continuous data over periods of weeks or months.

Oracle Health Sciences InForm EDC Platform
Infographic | Oracle Health Sciences

Deliver higher-quality data, faster and with less effort, cost, and risk.

New Ethics And Consent Guidelines Pillars For Safety In India
Podcast | DIA

In March 2019, the Health Ministry of India released new guidelines for clinical research. What is the state of premarket and post-market safety for patients and drugs in India six months after these new guidelines were announced? Listen to this podcast as experts share their perspective of post-market drug safety in India.

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