knowledge -WSS

knowledge

author：knowledge 2025-09-30 00:37:51 - browse：73

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： Medical records are filled with copy
Next article： Multiple sclerosis has subtypes with different best treatments: study

WSS

Heat wave can put hearts into ‘oxygen debt,' lab experiment shows

Alzheimer's risk factor APOE4 may be a distinct form of the disease

Statins may not be needed by millions of people, study suggests

Readout Newsletter: Biogen, Eisai, Aardvark Therapeutics, etc.

Alzheimer's risk factor APOE4 may be a distinct form of the disease

New report analyzes digital physical therapy solutions' effectiveness

focus

knowledge

This article is exclusive to STAT+ subscribers

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

leisure time

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

ALS patient reclaims some autonomy thanks to wearable 'robot'

Jerome Adams on the need for new antivirals for Covid

Young boy dies in trial for Pfizer Duchenne gene therapy

Drug repurposing or repositioning? The language matters

California wildfire smoke linked to 52,000 early deaths, study says

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Pancreatic cancer is often deadly, but new discoveries are raising hope

Jerome Adams on the need for new antivirals for Covid

UnitedHealth, in a surprise, takes aim at Steward’s physician group

knowledge

First Opinion on colorectal cancer screening: letter and response

Mass General Brigham physicians react to latest merger step

New report analyzes digital physical therapy solutions' effectiveness

Scientists uncover potential path to treating deadly childhood tumor

Medical device trials still don't enroll enough women, study finds

Multiple sclerosis has subtypes with different best treatments: study

hotspot

knowledge

knowledge

hotspot