Author: Lorri Bingham

CTTI Acknowledged for Contributing to FDA Sentinel Program in Applied Clinical Trials News Article

Posted on by Lorri Bingham

The Food and Drug Administration’s (FDA) Sentinel program was launched in 2008 and has been a considerable investment for the FDA, as indicated by Janet Woodcock in a recent Applied Clinical Trials news article. The Sentinel system is an important part of routine safety surveillance for pharmaceuticals and other medical products. The FDA plans to expand use of the Sentinel system to public health and quality improvement activities as well as effectiveness research in its “Guardian” system.

CTTI supported FDA efforts to explore the potential for using the Sentinel database beyond safety surveillance previously; CTTI and FDA’s Mini-Sentinel jointly published a report describing the capability and willingness of Mini-Sentinel’s Data Partners to collaborate in a variety of types of randomized trials, using the Mini-Sentinel (now Sentinel) Distributed Dataset. CTTI and Sentinel are now collaborating to design and implement a trial based on findings in the report. As mentioned in the recent Applied Clinical Trials news article, CTTI will facilitate the development and execution of a protocol for a randomized trial (IMPACT-AF) to study an educational intervention to improve the appropriate use of anti-coagulation for atrial fibrillation. This trial is a proof of concept study intended to determine whether it is possible to conduct a trial within the “Guardian” system. CTTI is proud to support the FDA’s efforts to expand their safety monitoring system to become a national resource with broader applications, specifically in more real-world clinical studies.

Wall Street Journal Tips Hat to CTTI’s Recruitment Project

Posted on by Lorri Bingham

WSJYesterday, the Wall Street Journal published an article on clinical trial recruitment, zeroing in on the critical need for improved patient recruitment rates. This article features CTTI’s Recruitment Project, which will be releasing official recommendations in a free, public webinar on May 19, 2016 from 12:00 – 1:00 PM EST. To receive details about this upcoming webinar, sign up for CTTI’s monthly e-newsletter here.

We are pleased to see the exploration of this important topic in mainstream international media and are proud to be a trusted voice in this space.

FDA Calls For More Patient Population Diversity in Clinical Trials; CTTI is Ready to Help

Posted on by Lorri Bingham

Historically, many clinical trial populations have lacked diversity and comprised predominantly white men. Because it is important that trial populations are representative of the actual patients to be treated with the investigational product, the U.S. Food and Drug Administration (FDA) has made a call for increased diversity in clinical trial participants. An article authored by FDA Commissioner Robert Califf in FDA Voice summarizes the current issues with trial recruitment and how the lack of participant diversity affects the evaluation of investigational drugs. Data gathered by the FDA show that “some groups, especially ethnic and racial groups, aren’t always represented in clinical trials” and that “these data are critical because certain groups of patients may respond differently to therapies.” His point is well supported by examples of underrepresentation of certain demographics in cardiovascular and schizophrenia trials and the resulting consequences.

In response to the need for greater trial population diversity, the FDA has planned or initiated several activities to encourage greater inclusion: the Diverse Women in Clinical Trials initiative, collaboration with the National Library of Medicine, and engagement with patient advocacy groups. Many of these activities are aligned with the goals of CTTI projects. For example, the CTTI Recruitment Project is developing communication planning approaches to engage all eligible participants and providers, including minorities and underrepresented populations. Furthermore, based on the results of the Informed Consent Project, CTTI recommends that the informed consent process be customized to meet the needs of each individual, and that those obtaining consent are trained to be responsive to potential research participants unique needs and concerns; these measures may help less health-literate participants feel comfortable participating in clinical trials. Finally, CTTI’s Patient Groups and Clinical Trials Project has provided recommendations on best practices for effective engagement with patient groups, which can facilitate involvement of patients from all walks of life.

CTTI is in agreement with the FDA’s call to action and is well positioned to provide support.

CTTI Webinar: Case Studies on Expedited IND Safety Reporting

Posted on by Lorri Bingham

Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations? Do you know someone who is interested?

CTTI invites you to participate in a webinar hosted by the IND Safety Advancement Project Team. This webinar is the first in a CTTI-hosted series designed to explore challenging safety reporting scenarios using case studies. We encourage you to share this invitation to others who may be interested in learning more about IND safety reporting.

Topic: Case Studies on Expedited IND Safety Reporting

Date: Thursday, April 21, 2016

Time: 12:00 p.m. – 1:00 p.m. EST

Presenters:

  • Patrick Archdeacon, Senior Clinical Advisor, Office of Medical Policy, Food and Drug Administration, Center for Drug Evaluation and Research
  • Annemarie Forrest, Associate Director of Projects, CTTI
  • Nina Stuccio, Head, Medical Safety Review, Global Clinical Safety & Pharmacovigilance, Merck, Inc.

WebEx Link
Meeting number: 735 340 171
Meeting password: ctti

After you connect to meeting website, please follow step-by-step instructions for connecting to the audio. If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 735 340 171

 

Materials from CTTI’s Unmet Need in Antibiotic Development Meeting Now Available

Posted on by Lorri Bingham

On March 1, 2016, CTTI hosted an expert meeting entitled, The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward. We are pleased to now share the meeting materials online, including the presentations, agenda, and attendee list.

This meeting was associated with the Unmet Need in Antibiotic Development Project. A variety of stakeholders attended, including academia, clinical experts, patient advocates, regulators, pharmaceutical companies, and others involved in the clinical research enterprise. The meeting objectives were to:

  • Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches
  • Identify focus group themes and discuss topics which should be further explored or where draft recommendations could be made
  • Obtain feedback to improve labeling, risk communication, public understanding and stewardship

 

CTTI Releases Annual Report of 2015 Accomplishments

Posted on by Lorri Bingham

CTTI’s recently released Annual Report spotlights major achievements of 2015, including the release of six sets of recommendations to improve clinical trials. Discover the significance of these recommendations directly from key stakeholders who are implementing them within their organizations.

We need a high quality clinical trial system that is patient-centered and efficient, enabling reliable and timely access to evidence-based therapeutic prevention and treatment options. CTTI moves the enterprise towards this vision through a multi-stakeholder approach and evidence-based work, which is generating real-world impact. We invite everyone to learn more about CTTI’s free resources and to use them to improve how clinical trials are done.

 

*You can use your arrow keys to advance slides in the report below. To view in a larger format, click the expand icon in the bottom, right corner of the slideshow after you begin reading.

 

CLICK HERE to download the PDF format of the 2015 Annual Report.

New Publication Points to Solutions to Reduce Unnecessary Burden on Clinical Trial Sites

Posted on by Lorri Bingham

Time and energy are valuable resources to clinical investigators. CTTI’s recent publication, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” provides evidence that redundant Good Clinical Practice (GCP) training places an unnecessary burden on investigators. Investigators should be relieved of the burden of repetitive training so they can focus on what matters most: protecting the rights, integrity, and confidentiality of clinical trial participants and assuring the credibility and accuracy of data and reported results. The authors offer suggestions to increase applied learning, focus on relevant trial information, and tailor training for specific job functions.

CTTI’s GCP Training Project team conducted a literature review to inform the project on current practices in the implementation of GCP training and analyzed sample GCP training programs. The findings were discussed by a multi-stakeholder group of experts who helped the team to develop official recommendations that were released in 2015. The recommendations include the 13 minimum essential elements for a training program, training frequency and format, and evidence of successful completion of training.

The paper was published in Therapeutic Innovation & Regulatory Science (TIRS).

CTTI Congratulates Dr. Robert Califf on his Confirmation as FDA Commissioner

Posted on by Lorri Bingham

Congratulations to Robert Califf, MD, former CTTI co-chair, on his confirmation as FDA Commissioner. Throughout his career, Dr. Califf has made considerable contributions to clinical care, clinical research and public health policy. CTTI colleagues have seen firsthand his commitment and leadership to improving clinical trials for the benefit of all patients. We are excited that he will have an opportunity to continue his dedicated service to improving the public’s health as the leader of the FDA.

A report on the decision from the Senate is located at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm487455.htm.

CTTI’s Mobile Clinical Trials Program is Recognized as Advancing Clinical Trials in The Guardian

Posted on by Lorri Bingham

CTTI’s Mobile Clinical Trials (MCT) Program focuses on integrating new mobile technologies in the design and conduct of clinical trials. Although medical research steadily progresses, the clinical trial enterprise can be slow to adopt new approaches and tools. As noted by Janet Woodcock in a recent article published by The Guardian, both pharmaceutical companies and regulators desire more innovation in the clinical trial setting. Aligned with this goal, the article recognized CTTI efforts to help increase innovation through initiating the MCT program. Dr. Martin Landray, a MCT Program leader and medical expert, was also quoted in the article, acknowledging that many currently used tests or metrics are outdated and do not provide the best information to guide patient treatment. He points out that wearable technology can provide more comprehensive data on a patient’s activities and health measurements. Additionally, according to The Guardian article, Landray

“estimates that in some cases, shifting to a mobile-based trial may reduce costs by 10-fold. This cost cutting, coupled with the fact that mobile trials’ recruitment efforts are not limited by geography, has the potential to advance our scientific understanding of rare diseases.”

CTTI is committed to helping the clinical trial enterprise explore the benefits offered by technological advancements with remote capabilities. The MCT Program seeks to address important issues related to the successful integration of mobile technologies in clinical trial conduct, including receptivity within the current legal/regulatory frameworks, stakeholder perceptions regarding risks and benefits of its use, and technical aspects of practical application.

CTTI Welcomes Newest Member Medidata Solutions

Posted on by Lorri Bingham

CTTI would like to welcome our newest member, Medidata Solutions.

Medidata Solution’s Vice President of Quality and Regulatory Affairs, Frances Nolan, will represent this organization on CTTI’s Steering Committee. Medidata Solutions is a global provider of cloud-based solutions for clinical research in life sciences.

We are pleased to have this new voice involved with CTTI’s work. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about the diverse representation of CTTI’s membership, click here.

 

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