We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

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

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

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

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

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Tufts CSDD Study Finds Adoption of Adaptive Clinical Trial Designs is Increasing"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

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.

Advertisement