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New Results on Cost Drivers in Phase 3 Drug Trials for HABP/VABP

Posted on by Lorri Bingham

Drug-resistant infections are on the rise, and one type of serious infection that can be caused by drug-resistant bacteria is hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Despite the desperate need for effective new therapies for HABP/VABP, clinical trials for this condition are lagging due to difficulties in conducting these trials and low expected return on investment. A new study from CTTI and the Tufts Center for the Study of Drug Development, published in Clinical Infectious Diseases, calculates the cost of phase 3 trials for HABP/VABP and identifies areas of opportunity to lower costs and boost investment in these critically important studies.

“To meet the urgent public health need for new antibacterial drugs, clinical trials must be more efficient, cost-effective and feasibly executed. Our study identified several factors driving clinical trial costs that can be targeted to optimize the development of new treatments,” said Ken Getz, an associate professor and researcher at Tufts University involved in the study.

“Leveraging evidence to direct meaningful changes in clinical trials is what CTTI is all about,” said Pamela Tenaerts, CTTI executive director. “We hope this information will help target efforts to streamline HABP/VABP trials, which will ultimately benefit patients.”

Key findings include:

  • The cost of a phase 3 HABP/VABP clinical trial averages $89.6 million, which is over double the average cost of a phase 3 oncology trial
  • Per patient, phase 3 HABP/VABP clinical trials were $2,300 more expensive than oncology clinical trials and $31,900 more expensive than endocrine trials
  • Screening failure rates and the cost of screening failures were the biggest drivers of cost, suggesting sponsors and research sites should consider ways to increase the number of potentially eligible patients

CTTI released recommendations for streamlining HABP/VABP trials and is testing novel approaches to make these trials more feasible, such as using predictive models to find and consent patients earlier in the disease process.

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.

CTTI Cited during the FDA’s Patient Engagement Advisory Committee Inaugural Meeting

Posted on by Lorri Bingham

Findings and recommendations from CTTI’s Patient Groups & Clinical Trials work were presented during the inaugural meeting of the FDA’s Patient Engagement Advisory Committee (PEAC) on Oct. 11-12, 2017.

At the meeting, Bray Patrick-Lake, director of stakeholder engagement, Duke Clinical Research Institute, discussed patient engagement efforts in the clinical trial enterprise and presented work conducted by CTTI to establish best practices for effective engagement with patient groups around clinical trials, which include:

  • Engage the “patient voice” by establishing partnerships from the beginning of the research and development program to improve trial design and execution
  • Clearly define the expectations, roles, and responsibilities of all partners, including the resources being committed, data being shared, and objectives of the program
  • Manage real or perceived conflicts of interest by establishing policies that require full disclosure, transparency, and accountability

The PEAC is composed of patients and caregivers who provide perspective to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. This first meeting brought together patients, patient organizations, FDA, industry, and other medical and scientific experts for discussion on incorporating patient perspectives in the design, conduct, and reporting of medical device clinical trials.

Meeting materials, including slide presentations, are available on the FDA website.

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.

Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

Posted on by Lorri Bingham

Mobile clinical trials (MCTs) offer several potential advantages, such as greater patient convenience, efficiencies in data collection, potential for novel endpoints, and enhanced participant retention.

However, despite the successful conduct of several MCTs for regulatory submission, the MCT model has yet to be widely adopted. This is due in part to presumed legal and regulatory issues in the U.S., such as the complexity of navigating different state medical licensing laws, patient and investigator oversight, and issues with the drug supply chain of custody.

In July 2017, CTTI convened a multi-stakeholder expert meeting to explore the legal and regulatory challenges inhibiting more widespread practice of MCTs, and to identify potential solutions. A meeting summary is now available highlighting main points from the discussion, including the following:

  • Highly varied state laws and regulations need to be thoroughly understood and recorded in an accessible location, e.g., a public database.
  • Guidance from regulatory bodies is needed to define principal investigators’ responsibilities regarding patient care oversight and potential delegation of activities,
  • Trials with a mobile clinical component should not be held to higher standards than traditional trials.
  • Patients and regulatory agencies should be engaged in trial design early in the development phase.

CTTI’s MCT Legal and Regulatory Project team will leverage themes and specific solutions from the multi-stakeholder discussions to develop recommendations and tools that will help address legal and regulatory challenges currently associated with MCTs.

 

This work is part of CTTI’s MCT Program, which is also exploring other topics and barriers related to planning for and conducting MCTs.

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