CTTI News

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.

 

CTTI MEMBERSHIP:

CTTI Membership

CTTI Calls for Increased Public Involvement in Clinical Trials

Posted on by Lorri Bingham

Media PlanetCTTI directors Pamela Tenaerts, Bray Patrick-Lake, Leanne Madre, and Matthew Harker authored an article featured in Clinical Trials, a Mediaplanet supplement to the December 18th edition of USA Today. The article “Throwing Your Hat in the Ring?” appears on page 4 and makes a general call to the American public for increased awareness of and participation in clinical trials. CTTI highlights the importance of clinical research and encourages Americans of all walks of life to consider participating in them. The article dispels the myth that an individual must be ill or of a certain demographic population to be a trial participant; everyone can and should participate in clinical research.

Medical advancements rely on clinical trial data, and the data cannot be generated without willing participants. Let’s all pitch in so we may all reap the benefits. CTTI recommendations can help the advancement of clinical trials.

 

To read the full article, click here.

Recently Released: Expert Meeting Summary on Recruitment

Posted on by Lorri Bingham

On November 9 – 10, 2015, CTTI’s Recruitment Project Team hosted a multi-stakeholder, expert meeting to address the following objectives:

  • Present findings from the CTTI Recruitment Project’s evidence-gathering activities
  • Obtain stakeholder perspectives and critical feedback on draft considerations for more effective recruitment planning
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for moving recruitment planning upstream and achieving culture change
  • Identify implementation barriers to achieving change
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for overcoming barriers to achieving change

Maximizing recruitment efforts depends on the design and feasibility of the clinical trial protocol and site selection, as well as appropriate communication planning. Attendees discussed how to improve clinical trial recruitment efforts by incorporating Quality by Design (QbD) concepts into recruitment planning strategies, identifying and engaging important stakeholders, viewing recruitment through a patient-centric lens, and crafting and positioning the right messaging to encourage the public to inquire about recruitment opportunities. Experts presented and discussed current patient and public perceptions of clinical research and how this impacts trial recruitment. To improve recruitment overall, participants acknowledged that trust and better rapport among research scientists/medical professionals and patients/the public need to be fostered. Additionally, recruitment planning cannot rely on a one-size-fits-all approach; recruitment efforts must be fit for purpose and tailored to individual trials.

CTTI Work is Referenced in the FDA’s New Draft Guidance on Safety Assessment for IND Safety Reporting

Posted on by Lorri Bingham

The FDA issued a draft guidance in December 2015 on Safety Assessment for IND Safety Reporting. This guidance was developed as a follow-on to the 2010 guidance for Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations to help sponsors meet their obligations under 21 CFR 312.32. The FDA provides recommendations on the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and development of a safety surveillance plan.

Page 4 of the guidance references CTTI work conducted by the IND Safety Project Team. (Recommendations developed during this project are available here.) The FDA addressed an observation that emerged during the IND Safety Project’s analysis of the evidence from surveys and multi-stakeholder expert meetings: sponsors have concerns about protecting trial integrity when reviewing serious adverse data from ongoing trials. To maintain trial integrity while assessing safety signals, the FDA recommends that sponsors use a safety assessment committee and develop a safety surveillance plan.

Comments on this draft guidance will be accepted until February 16, 2016.

CTTI continues to work in this area: the IND Safety Advancement Project is a follow-on to the IND Safety Project. This follow-on project seeks to promote full implementation of the FDA’s final rule by addressing particular challenges in oncology trials and generalizing solutions to other therapeutic areas.