focus -WSS

focus

author：comprehensive 2025-09-06 01:58:36 - browse：592

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： Anesthesiologist group: stop taking Ozempic before surgery
Next article： Was Amgen transparent enough on FDA's concern on cancer drug?

hotspot

WSS

Fed up with FDA, ALS advocates consider a take

Akili changes sales model for its ADHD video game treatment

Stroke deaths set to near 10 million globally by 2050

Physician executives need more than on

Senate bill would ban some hospital facility fees

Was Amgen transparent enough on FDA's concern on cancer drug?

hotspot

focus

This article is exclusive to STAT+ subscribers

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

hotspot

Wildfire smoke exposes gaps in outdoor worker protections

Physician executives need more than on

At least 13 dead in Texas as scorching temps continue

David Liu startup to focus on CRISPR delivery

Peter Hotez and the public health issue of online harassment

A Q&A with the global head of Boehringer Ingelheim's innovation unit

As demand for Covid shots wanes, Moderna seeks its next success

Bristol 'take

In Memoriam: Notable people who died in 2023

House panel takes first step toward fixing drug shortages

Wikipedia

Histogen: Failed biotech offers rare public look inside

In $4.8 billion deal, Bristol Myers Squibb to buy cancer player Mirati

Was Amgen transparent enough on FDA's concern on cancer drug?

Medicare to pay more for cardiac rehab in hospital outpatient clinics

Akili changes sales model for its ADHD video game treatment

When women are denied an abortion, their children fare worse than peers

hotspot

hotspot

entertainment

leisure time