CTTI News

CTTI and Precision Medicine

Posted on by Lorri Bingham

On January 30, 2015, President Obama unveiled details about the Precision Medicine Initiative, a new research effort intended to revolutionize how we improve health and treat disease. Several CTTI affiliates were invited to take part in the announcement. After an afternoon in the White House, the synergy between this federal initiative and CTTI’s work was clear.

CTTI co-chair Dr. Robert Califf found the event to be a call-to-action for CTTI to redouble efforts to streamline clinical trials, so that accelerated technology development can lead to practice based on high quality evidence. Furthermore, CTTI’s pioneering work in patient engagement is consonant with the proposed new model of patient-powered research to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

Following the presidential announcement, 30 leaders from the patient community joined NIH Director Francis Collins for lunch to explore their hopes and fears about the effort. CTTI’s director of stakeholder engagement, Bray Patrick-Lake, was in attendance and reports that members of the patient community spoke to their great hopes in the science and commitment of NIH and the White House. These sentiments were perhaps best stated by 11-year-old rare disease patient Beatrice Rienhoff who said it was the best day of her life; however other patients articulated that fears remain around the IRB and informed consent impediments in the current research system. This makes CTTI’s work on these topics and others even more timely, relevant and urgent.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 2)

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The second webinar in this series recently took place on January 14, 2015 and featured speakers from The Medicines Company and AstraZeneca who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here. The final webinar in this series is scheduled for Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST.

CTTI Recommendations for Improving GCP Training to be Unveiled

Posted on by Lorri Bingham

CTTI’s GCP Training Project set out to develop recommendations for streamlining GCP training practices. After assessing data on current training programs and gaining consensus around strategies to reduce the burden of redundant training, CTTI’s multi-stakeholder working group has developed recommendations on the content and frequency for GCP training.

The final results and recommendations of this project will be unveiled on January 29, 2015 in a public webinar hosted by the Society for Clinical Research Sites (SCRS). We invite our colleagues in the clinical trials enterprise to attend this exciting event and we encourage the sharing of this invitation.

Additional information on this webinar is listed below:

Webinar: A New View: How Frequently is GCP Training Needed and What Should Be Included?

Panelists:

  • Bridget Foltz, MS, MT (ASCP) | U.S. Food and Drug Administration
  • Michael Koren, MD, FACC, CPI | Jacksonville Center for Clinical Research
  • Jonathan Seltzer, MD, MBA, MA, FACC | ACI Clinical
  • Gretchen Wild, MBA, MHA | St. Jude Medical

Date: January 29, 2015 at 12:00 PM EST

Cost: Free

Registration: Click here to register. (After registration, you will be emailed the login details.)

CTTI Welcomes 3 New Members

Posted on by Lorri Bingham

CTTI would like to welcome our three newest members: Life Raft, the MPN Research Foundation, and the Foundation for Prader-Willi Research.

 

Life Raft

Life Raft provides support through information, education, and innovative research to patients with a rare cancer called GIST (Gastrointestinal Stromal Tumor). Executive Director Norman Scherzer will represent this organization on CTTI’s Steering Committee.

 

MPN Research Foundation

The MPN Research Foundation works to stimulate original research in pursuit of new treatments for myeloproliferative neoplasms (MPN). Deputy Director Michelle Woehrle will represent this organization on CTTI’s Steering Committee.

 

Foundation for Prader-Willi Research

The Foundation for Prader-Willi Research works to eliminate the challenges of the genetic disorder known as the Prader-Willi syndrome through the advancement of research. Director of Research Programs Theresa Strong will represent for this organization on CTTI’s Steering Committee.

 

 

As patient groups, these organizations represent one of many key stakeholders that CTTI engages to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about CTTI’s organizational structure, including the Steering Committee, CLICK HERE.

CTTI Webinar Provides Real-World Examples of Quality by Design (QbD) in Clinical Trials (Part 2)

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. (Click here to view the first webinar in this series.)

Topic: Translating Quality by Design Principles into Practice, Part 2

Date: Wednesday, January 14, 2015

Time: 11:00 a.m. – 12:00 p.m. Eastern Standard Time (New York, GMT-05:00)

Agenda:

  • CTTI QbD Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical QA Strategy, Janssen
  • Quality Management in Clinical Trials: Keeping it Simple by Sabrina Comic-Savic, MD, MPH Senior Director, GCP Compliance, The Medicines Company
  • QbD – An Example from a Running CV Outcome Trial by Helene DuPui-Ekdal Director, Clinical Development, AstraZeneca
  • Q & A

THIS WEBINAR IS OPEN TO THE PUBLIC. WE ENCOURAGE YOU TO FORWARD THIS INVITATION TO OTHERS WHO MAY BE INTERESTED IN LEARNING MORE ABOUT QBD IMPLEMENTATION.

To join the webinar on January 14, go to:
https://dukemed.webex.com/dukemed/j.php?MTID=m6674f0b144ed076e5afb9322a67442d9
Meeting Number: 738 965 414
Meeting Password: ctti

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)

The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

Mark your calendars. The QbD Webinar Series will continue on the following date:

Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)

CTTI’s Tools for Improving Clinical Trial Quality & Efficiency

Posted on by Lorri Bingham

In our pursuit to enhance the implementation of CTTI’s recommendations, we’ve created a new webpage on our site that we’d like to share with you. This page features CTTI’s three most commonly used tools:

  1. The Considerations Document for a Single IRB of Record: Developed by CTTI’s Central IRB Project, this tool supports communication and contractual relationships between institutions and a central IRB to address blurred distinctions between responsibilities for ethics review and other institutional obligations. Primary users for this tool include sponsors, academic institutions, investigators, IRBs that act as a single IRB of record.
  2. The Quality by Design Principles Document: Developed by CTTI’s QbD Project, this tool helps those working in trials to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. Primary users for this tool include anyone interested in designing and conducting clinical trials.
  3. The AACT Database: Developed by CTTI’s State of Clinical Trials Project, this tool makes the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Primary users for this tool include researchers interested in analyzing data from clinical trials.

The Tools Page can be accessed on the CTTI site under Briefing Room > Tools. We hope that you find this resource valuable and share with your colleagues in the clinical trials enterprise.

Deadline Extended for Individual Patient/Caregiver Representative Application

Posted on by Lorri Bingham

The deadline to apply to be an individual patient/caregiver representative with CTTI has been extended to December 17, 2014. If you are a patient or caregiver who is passionate about improving the clinical trial process and you have an understanding of the clinical trial system, including related regulations, click here for more information.

NIH Encourages the Use of Central IRBs in Multi-Site Clinical Trials and CTTI’s Tools Can Assist with Implementation

Posted on by Lorri Bingham

Yesterday, the NIH issued a draft policy encouraging the use of single Institutional Review Boards (IRBs) in all NIH-funded multi-site clinical trials. The rationale behind this new policy was spelled out simply:

When regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Multi-site studies often are able to recruit more individuals from diverse populations and generate important results in less time. However, working through IRB review at each site can add delay without increasing the ethical protections for the research participants in the study. (NIH Clinical Research Policy)

CTTI’s Central IRB Project came to similar conclusions. One of the key takeaways from this project was that sites could become more comfortable using this streamlined review model if government and commercial sponsors required the use of a single IRB as a condition for participating in a particular multi-center trial. We are pleased to see a policy in accordance with our recommendations, and that CTTI’s work was cited. We are confident that these steps will improve the efficiency of clinical trials in the US.

In their concluding remarks, the NIH points out some of the potential hurdles for adopting their guidance:

Despite enthusiasm for central IRBs, there is confusion about the optimal structure for central IRBs as well as how best to meet regulatory requirements. There are questions about the loci of responsibilities and whether the IRB or institutions will bear the blame if adverse events occur. (NIH Clinical Research Policy)

Serious adverse event reporting of is one of the items discussed in the CTTI-developed guide, known as the Considerations Document. The guide can be used by institutions and central IRBs when negotiating legal and ethical responsibilities for multi-center clinical trial.

CTTI’s Patient Engagement 2.0 Strategy seals Patient Groups as Equal Partners in the Clinical Research Process

Posted on by Lorri Bingham

While patient representatives have been engaged since its inception, CTTI underscored the vital importance of meaningful patient engagement in the clinical trials enterprise (CTE) by launching its Patient Leadership Council (PLC) in January 2013. Through the PLC, 15 patient thought leaders representing a variety of organizations engaged in clinical trials came together, outside of disease or body part, to work hand in hand with CTTI’s diverse membership to create solutions. Since the establishment of the PLC, this group’s impact on CTTI’s work has been undeniable.

Not only did PLC members increasingly serve as project team leaders and integral team members, CTTI’s membership and Executive Committee fast-tracked approval of a project developed by the PLC entitled Patient Groups & Clinical Trials–which follows CTTI’s multi-stakeholder approach and aims to identify and promote best practices for effective engagements between sponsors of research and patient groups around clinical trials. The PLC also created presentations and events for CTTI’s membership that highlighted innovative programs and approaches developed by patient groups to overcome barriers in clinical trials.

In light of the impact made in the PLC’s first 18 months, CTTI convened a Summit with its patient representatives in July 2014 to explore lessons learned and define what Patient Engagement 2.0 should look like at CTTI. On this day, it was affirmed that the greatest accomplishments were achieved by working in direct partnership with other stakeholders and that panels had greater impact when voices from diverse stakeholder groups were included. Thus, the PLC decided it should be dissolved and its members integrated into CTTI’s Steering Committee as of January 2015. Furthermore, representatives of the patient community should have responsibilities and representation equal to all other stakeholders at CTTI. In the case of patient advocacy organizations, this includes applying and paying a nominal annual fee for membership rather than being convened as a distinct entity via invitation. The leaders recommended that individual patient and caregiver representatives should continue to be selected via competitive process for positions that include travel support to ensure their ability to participate.

In sum, the message from this body of thought leaders is clear: The patient community must be equal partners in every aspect of the clinical trial enterprise in order to improve the quality and efficiency of clinical trial; Patient Engagement 2.0 is a final step for achieving this at CTTI. Stay tuned for recommendations from CTTI’s project on Patient Groups & Clinical Trials. For information on applying for CTTI membership, click here.

CTTI Highlights Patient Partnerships at Upcoming FDA & SCT/QSPI Workshop

Posted on by Lorri Bingham

On December 9-10, 2014, the FDA and SCT/QSPI will host an interactive workshop titled Innovations in the Science and Practice of Clinical Trials in Rockville, Maryland. This multidisciplinary workshop brings together thought leaders from the FDA, industry, academia, and patient groups for direct and open discussions on recent innovations in the science and practice of clinical trials.

On Wednesday, the session titled Patient Partnership in Clinical Trial Design and Conduct will focus on patient group engagement and regulatory efforts to include patient preferences in decision-making. CTTI’s Patient Leadership Council Liaison on the Executive Committee, Veronica Todaro, will present Patient Engagement in the Clinical Trial Enterprise, followed by CTTI member Sharon Hesterlee presenting Current Patient Engagement Practices in Clinical Trials — A Survey.

We look forward to connecting with our colleagues at this event. To view the detailed program for this event, click here.

If you are interested in patient partnerships in clinical trials, you should know about CTTI’s project, Best Practices for Effective Engagement with Patient Groups around Clinical Trials. The objective of this project is to identify best practices for engaging patient groups that will lead to more efficient and successful clinical trials. Hesterlee’s presentation on Wednesday is connected to this project.