knowledge -WSS

knowledge

author：entertainment 2025-09-30 17:03:43 - browse：3566

A hand in pink glove holds a blue rack that contains three tubes of blood samples — first opinion coverage from STAT — Joe Raedle/Getty Images

During my 25 years working in clinical trial operations, I’ve seen the biopharmaceutical world talk a big game about making the process easier for the sites running the trials and the patients participating in them. Everyone from trial sponsors to the Food and Drug Administration has been quick to promise simpler processes, less hassle, and better experiences for everyone involved.

But look closer, and you’ll see that these grand promises often fall apart when sponsors implement complicated plans for collecting blood, tissue and other biospecimens and impossible processes for managing those samples. Behind all the talk and regulatory guidance, there’s a reluctance to change how these essential elements of clinical trial execution are handled, putting the very ideals that sponsors are trying to uphold at risk.

The concept of site and patient centricity frequently gets reduced to addressing only superficial gestures, such as committing to promptly paying sites for their work or using tablets for conducting patient surveys. But the essence of centricity extends far beyond these surface-level measures. It lies in addressing the unseen and unmentioned complexities of clinical trials and providing real solutions that focus on truly prioritizing the needs of trial sites and participants.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Hollywood unions extend contract negotiations for actors
Next article： Today's health inequities arise from racist U.S. history, say experts

WSS

Flagship Pioneering startup Sonata Therapeutics lays off 21

Medicare Advantage enrollment grows 7.1% to 33.4 million people

How state and local governments are sidelining science

Readout Newsletter: Novo Nordisk trial, Verve base editing, etc

Medical school prerequisites are outdated

Bipartisan group of lawmakers warns of a rising Chinese threat to U.S. biotech

focus

knowledge

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.

entertainment

Malaria cases in Florida and Texas: Here’s what you need to know

AbbVie CEO Gonzalez to step down after a decade fiercely defending Humira

Moonlake's readout produced a cash windfall. Risks remain

How state and local governments are sidelining science

New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

First transplant of an entire human eye performed

At least 13 dead in Texas as scorching temps continue

Hospitals are piloting generative AI tools as regulators play catch

Bright Health sells Medicare Advantage business to Molina

Researchers tackle phage therapy hurdles for wider adoption

explore

Readout Newsletter: Zepbound, Valneva's vaccine, and more

Ventyx halts psoriasis drug development after lackluster trial results

A letter from the executive editor: STAT UnitedHealth investigation

Measles policy set amid Florida outbreak alarms vaccine proponents

FDA cancer chief on how to get things done: ‘Don’t tell anybody'

FDA reorg will put new emphasis on investigations, sources say

focus

leisure time

leisure time

focus