Investigators

CTTI to Offer Insights on Investigator Qualification, Mobile Technologies, and Other Opportunities in Clinical Research at ACRP 2018

Posted on by Lorri Bingham

The ACRP 2018 education and networking event will feature three presentations from CTTI highlighting evidence-based strategies for enhancing clinical trial quality and efficiency. The event will take place in National Harbor, Md., from April 27-30.

On Sat., April 28, CTTI Executive Director Pamela Tenaerts will join leaders across the clinical trials enterprise to discuss collaborative initiatives to improve clinical research, including investigator qualification, quality by design, the use of mobile technologies, and more.

The following day, CTTI will share findings from its Investigator Qualification Project, which explores how best to ensure the efficient and effective qualification of site investigators and their delegates for the quality conduct of clinical trials. In a recent ACRP article, presenter Janette Panhuis of PHRI underscores the importance of CTTI’s work to move the clinical trials enterprise toward more meaningful investigator training.

On Mon., April 30, CTTI will discuss outcomes of in-depth interviews with investigators who have conducted both traditional clinical trials and studies using mobile technologies, providing insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for investigative site personnel to consider. Read more about CTTI’s MCT Stakeholder Perceptions Project.

We hope you will be able to join us at ACRP 2018. Please visit the CTTI Events page for more information about these and other upcoming CTTI presentations.

Presentation: Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership

Date & Time: Sat., April 28, 8:00 – 9:00 a.m.

Presenters: Pamela Tenaerts (CTTI), Patricia Leuchten (The Avoca Group), Douglas Peddicord (Association of Clinical Research Organizations), and Andy Lee (Merck)

Presentation: Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project

Date & Time: Sun., April 29, 11:30 a.m. – 12:30 p.m.

Presenters: Sabrina Comic-Savic (The Medicines Company), Bridget Foltz (FDA), Janette Panhuis (PHRI), and Diana Foster (ACRP)

Presentation: Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project
Date & Time: Mon., April 30, 9:30 – 10:30 a.m.

Presenters: Steve Morin (FDA) and Virginia Nido (Genentech, a member of the Roche Group)

CTTI Explores How to Prepare Qualified Investigators and their Delegates: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Although good clinical practice (GCP) training has long been considered the industry standard for ensuring investigators are qualified for the high-quality conduct of clinical trials, little evidence has been collected to determine whether it actually provides the knowledge and skills to equip investigators and their delegates to conduct clinical trials.

To address this issue, CTTI convened an expert meeting in December 2017 to discuss action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. The meeting (see one-page summary) included representatives from pharmaceutical companies, government, research sites, contract research organizations, patient representatives, and other groups.

Meeting participants collaborated to refine a draft framework defining characteristics synonymous with the quality conduct of clinical trials. They discussed the need to shift the focus from individual investigators to the entire study team and identified value in mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their specific roles. In addition, participants probed how it may be possible to develop and deliver more patient-centric training, foster a culture of learning, and drive the evolution of investigator qualification to include more adult learning approaches and a focus on how to apply knowledge—not just recall it. Attendees also identified the need for a harmonized system to better help sponsors identify suitable sites without mandating specific training.

As a next step in its Investigator Qualification work, CTTI will develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.

CTTI Shares New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference

Posted on by Lorri Bingham

CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference.

On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent and enrollment in clinical trials. While early enrollment could improve the ability to conduct trials that evaluate the efficacy and safety of treatments for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), questions remain about implementing it ethically and effectively. CTTI will share findings from its HABP/VABP Studies Project on the acceptability of an early informed consent approach for high-risk patients and essential information that should be shared with key stakeholders.

On Wed., Nov. 8, CTTI will discuss findings from its MCT Legal & Regulatory Project on actual and perceived barriers that may be preventing the widespread use of mobile technology in clinical trials. Presenters will explore potential challenges and opportunities of conducting clinical research remotely, and solicit input from clinical enterprise stakeholders on potential ethics implications. The project is part of CTTI’s Mobile Clinical Trials (MCT) Program.

In a separate session, CTTI will also present findings to date for its Investigator Qualification project and Investigator Community recommendations. The presenter will examine whether current GCP training methods actually provide the knowledge and skills necessary to conduct quality clinical trials. Further, he will detail recently released recommendations that aim to strengthen the clinical trials investigator and study team community through better training and other approaches.

We hope you will join us in San Antonio, Texas, Nov. 5-8 as we share new insights into these noteworthy clinical trials topics.

Presentation: Stakeholder Perceptions on Early Informed Consent for Clinical Trials
Date & Time: Mon., Nov. 6, 3:30 – 4:45 p.m.
Presenters: Amy Corneli (CTTI) and Thomas Holland (Duke University)

Presentation: Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials, Legal, and Regulatory Project
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: David Babaian (Kinetiq), Linda Coleman (Yale University), and Jan Hewett (FDA

Presentation: Beyond Good Clinical Practice (GCP) Training: Expanding the Tool Set for Preparing Investigators
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: Gerrit Hamre (CTTI)

Webinar Recording Now Available: Strengthening the Investigator Site Community

Posted on by Lorri Bingham

Running a clinical trial at a research site is always challenging, and investigators may sometimes feel like the deck is stacked against them.

CTTI’s most recent webinar, Strengthening the Investigator Site Community, featured expert presenters and panelists discussing the challenges faced by site investigators. They also shared real-life examples of how CTTI’s new recommendations can be used by CROs, sponsors, health systems, investigators, and others to create a more supportive environment for site-based research.

 

 

CTTI Recommendations Strengthening the Investigator Site Community from CTTI on Vimeo.

View the webinar recording to learn how:

  • Workload, reporting burdens, time allocation, and financial issues contribute to high rates of investigator turnover;
  • Investigators and study staff can benefit from improvements to research infrastructure and training and educational opportunities;
  • All stakeholders can contribute to optimizing trial conduct and to developing more efficient and transparent approaches to budgeting and contracting; and
  • Investigators can connect with opportunities to remain engaged in clinical research.

Visit this page for presenter information and to download a copy of the slides.

Webinar Coming: Strengthening the Site Investigator Community for a More Sustainable Clinical Trials Enterprise

Posted on by Lorri Bingham

High rates of turnover among clinical site investigators and a shrinking pool of experienced researchers together threaten to harm the efficiency and quality of clinical trials. CTTI has responded to these challenges with actionable, evidence-based recommendations for strengthening and growing the site investigator community.

The recommendations—which are based on stakeholder input, survey and interview results, and an extensive analysis of data from the FDA’s publicly available Bioresearch Monitoring Information System (BMIS) database—will be discussed during a CTTI Webinar on Thurs., Oct. 19, at noon ET. Addressing multiple facets of the clinical trials process from the perspectives of investigators and support staff, trial sponsors, clinical research organizations, and health systems, the recommendations address four major themes:

  • Developing site-based research infrastructure and staff
  • Optimizing trial execution and conduct
  • Improving site budget and contract negotiations
  • Identifying additional trial opportunities for interested investigators

Please visit the webinar page to add this event to your calendar.

New CTTI Investigator Community Recommendations a Focus at SCRS Global Site Solutions Summit

Posted on by Lorri Bingham

Evidence suggests that many investigators are leaving clinical research due to burdens imposed by trial-related responsibilities—a trend that could hinder the quality and efficiency of clinical trials. CTTI is addressing these and other issues in a rollout of evidence-based investigator community recommendations.

At the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Sat., Oct. 7, CTTI will present its new set of recommendations designed to support and strengthen the site investigator community through activities aimed at:

  • Developing site-based research infrastructure and staff
  • Optimizing trial execution and conduct
  • Improving site budget and contract negotiations
  • Identifying additional trial opportunities for interested investigators

These recommendations, which lay out practical strategies that can help all stakeholders contribute to building a more supportive and sustainable clinical trials enterprise, were developed through CTTI’s Investigator Community Project.

Panel Discussion: Four Ways to Grow & Maintain a Strong Investigator Community
Date & Time: Sat., Oct. 7, 4:30-5:30 PM EDT (8:30-9:30 PM GMT)
Presenters:

  • Robin Douglas, Site Solutions Director, Site and Patient Networks, QuintilesIMS
  • Doug Peddicord, Executive Director, Association of Clinical Research Organizations
  • Gerrit Hamre, Project Leader, Clinical Trials Transformation Initiative

Strengthening the Investigator Site Community

Posted on by Lorri Bingham

Gain new insights into challenges affecting investigator retention and potential solutions

Evidence shows that the pool of qualified clinical investigators in the United States is shrinking, while at the same time a high percentage of investigators are likely to stop leading trials after conducting just a single drug study—trends that threaten the quality and efficiency of U.S. regulatory trials.

On April 5, 2017, CTTI convened an expert meeting to explore this issue and others related to clinical trial investigator turnover and retention. A comprehensive meeting summary presents survey and interview data gathered from current and former trial investigators and explores approaches that can help investigators overcome the practical challenges of conducting clinical trials.

CTTI’s Investigator Community Project was created to better understand why some clinical investigators remain actively engaged in clinical research but others decide to leave it after a single experience. CTTI is applying these insights to develop strategies that can improve investigator retention and reduce turnover, ultimately leading to more efficient, higher-quality clinical trials. The multi-stakeholder project team will continue to review evidence and incorporate consensus findings from the expert meeting as it develops recommendations and other products that can be used to strengthen the investigator community.