knowledge -WSS

knowledge

author：focus 2025-08-25 07:27:39 - browse：6

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： ChatGPT in medicine: STAT answers readers' burning questions
Next article： Readout Newsletter: Sanofi, Novavax, Maze x Shionogi news

WSS

Shionogi licenses Pompe disease therapy from Maze Therapeutics

Readout LOUD podcast: What to know about H5N1 bird flu

Readout LOUD podcast: What to know about H5N1 bird flu

ASCO: Palliative care found as helpful given virtually as in person

BMI, flaws aside, is found to be useful estimate of body fat in youth

Ultragenyx gene therapy for rare liver ailment succeeds in late

hotspot

knowledge

This article is exclusive to STAT+ subscribers

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

leisure time

Anesthesiologist group: stop taking Ozempic before surgery

See how much Covid

In Memoriam: Notable people who died in 2023

Shifting the focus from loneliness to social health

Continuity nursing helped my family in our darkest PICU moments

ASCO: AstraZeneca's Tagrisso greatly slowed some lung cancers

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

See how much Covid

Jerome Adams on the need for new antivirals for Covid

Elevance, private equity launch primary care company

hotspot

FDA's Pazdur wants cancer trials to range beyond China alone

Kaiser's Risant Health gobbled up Geisinger. Who is next?

Study: People of West African ancestry at greater risk of cardiac amyloidosis

CDC wastewater surveillance dashboard to track bird flu hotspots

Dairy farmers resist CDC push for PPE against bird flu virus

NIH documents show early flaws of $1.6 billion long Covid program

focus

focus

focus

explore