The Clinical Trials Transformation Initiative (CTTI) unveiled recommendations and resources that propose a new approach for investigator qualification--one that goes beyond repetitive training and includes individual experience and protocol-specific preparation.

In a special event at the U.S. Food and Drug Administration (FDA) today, the Clinical Trials Transformation Initiative (CTTI) will unveil recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

In a public Celebration Symposium on Feb. 6, leaders from across the clinical trials enterprise will gather to celebrate CTTI's 10-year anniversary. The exciting lineup of speakers will share case studies illustrating the benefits of applying CTTI’s clinical trial recommendations and moderate a vibrant exchange of ideas on the future of the clinical trials enterprise.

The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. CTTI's newly released recommendations and tools aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. CTTI’s new recommendations for making pediatric antibacterial trials more successful. These practical, evidence-based strategies can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials or pediatric trials in other therapeutic areas.

CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available for download at http://bit.ly/recruitment-recs. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publically available, according to Duke Medicine researchers.

Potential participants in clinical trials may not have a clear understanding of the methods used by researchers to ensure the safety of investigational drugs they are given.

Fueled in part by an inclination to speed new treatments to patients, research studies for cancer therapies tend to be smaller and less robust than for other diseases.

As part of an effort to improve the way clinical trials are conducted, the Clinical Trials Transformation Initiative (CTTI) has formed a 16-member council to engage patient advocates in its mission.

The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.

The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making.

A public-private partnership comprising over 60 organizations has announced recommendations to improve clinical trials by ensuring quality with effective and efficient monitoring and improving safety through better methods of reporting unexpected serious adverse events to investigators.

Under an agreement between the U.S. Food and Drug Administration and Duke University Medical Center, Duke will host a Public-Private Partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia.