Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Tufts CSDD Study Finds Adoption of Adaptive Clinical Trial Designs is Increasing

Published: Friday, May 24, 2013
Last Updated: Friday, May 24, 2013
Bookmark and Share
Report shows growing acceptance by pharmaceutical companies and regulatory agencies.

Aptiv Solutions announces publication of a Tufts Center for the Study of Drug Development (CSDD) report on the adoption and impact of adaptive trial designs.

Adaptive designs allow pre-planned modifications to clinical trials, such as terminating studies early to spare patients from ineffective drugs or adding patients to help ensure the trial will return a statistically significant result.

Approximately 20% of clinical trials currently underway already use adaptive designs, according to Tufts CSDD’s research. The study indicates adoption should increase significantly in the next few years, particularly for exploratory phase trials. In a session previewing the report, the majority of forty executives from top pharmaceutical companies agreed that futility analysis should become standard practice in all phase II and III studies. Data indicates widespread use of simple adaptive designs, such as early study terminations due to futility and sample size re-estimation, could save sponsor organizations $100 to $200 million annually.

“The industry is investing heavily in improving clinical trial quality and efficiency and now years of evidence has made the promise of adaptive designs clear. Yet, barriers remain to this approach reaching its full potential to protect patients and free R&D dollars for more therapies and devices,” says Pat Donnelly, Chairman and Chief Executive Officer of Aptiv Solutions.

“An important finding of our study was that a primary factor limiting adoption of adaptive designs is internal organizational resistance, not lack of support from regulatory agencies. Study participants believe that internal functions, for example regulatory affairs, are risk-averse and prefer more clarity from regulatory agencies. Regulatory agencies, on the other hand, have provided guidance, and appear to be receptive to exploratory phase adaptive trial designs,” says Ken Getz, Director of Sponsored Research at Tufts CSDD.

“Adaptive trials allow study sponsors to react to data acquired during an investigation and make adjustments, improving the utility of information the studies provide to patients, doctors, regulators, and sponsors. It’s like crossing the road with your eyes open. The time is right for sponsor companies to expand their use of adaptive designs” says Donnelly.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Aptiv Solutions to be Acquired by ICON
Combined companies provide unrivalled capabilities for adaptive and medical device trials worldwide.
Monday, March 31, 2014
Aptiv Solutions Growing: Opens New Office in North Carolina
New office is located at 4505 Emperor Boulevard in the Imperial Center.
Monday, December 10, 2012
Scientific News
Drug to Treat Alcohol Use Disorder Shows Promise Among Drinkers With High Stress
The findings suggest that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress.
Scientists Find Lethal Vulnerability in Treatment-Resistant Lung Cancer
The study describes how the drug Selinexor killed lung cancer cells and shrank tumors in mice when used against cancers driven by the aggressive and difficult-to-treat KRAS cancer gene.
Advanced Lymphoma in Remission After T-Cell Therapy
63% of trial participants who recieved two-drug combination chemo plus intermediate dose of engineered T cells went into complete remission.
New Treatment for Immune Cancers
Clinical trial shows new drug holds promise for treating advanced mastocytosis.
Sickle Cell Gene Therapy Passes Test
Researchers found a precision-engineered gene therapy virus reduced sickle-induced red-cell damage in mice with sickle cell disease.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Vitamin C May Boost Leukemia Treatment
Studies show that supplementing an epigenetic cancer drug with vitamin C enhanced the drug's effectiveness.
Inovio Launches Zika Vaccine Trial
Inovio launches Zika vaccine trial in midst of Puerto Rico epidemic to explore early signals of vaccine efficacy.
New Hope for Zika Treatment Found in Large-Scale Screen of Existing Drugs
Johns Hopkins researchers join collaborative group to screen 6,000 existing drugs in hopes of finding treatments for Zika Virus infection
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!