Tomorrow, CTTI’s Executive Director Pamela Tenaerts will be speaking on an expert panel for The Forum at Harvard T.H. Chan School of Public Health, a live webcasting series that aims to provide decision-makers with a global platform to discuss policy choices and scientific controversies.

This Forum will explore the challenges and complexities of drug trials, and how they impact disease treatment and prevention – particularly for conditions that currently have little or no therapeutic options. As a case study, the panel will discuss Alzheimer’s and several drugs in development for that disease, but also address broader concerns related to the pharmaceutical testing pipeline for unmet medical needs as a whole.

Webinar: DRUG TRIALS: Challenges for Alzheimer’s and Other Urgent Needs
Date: Friday, April 15, 2016
Time: Noon-1 PM ET

Below, you can find information about joining the conversation in real time:

• Live tweet with @ForumHSPH #drugtrials
• Questions for panelists can be sent to theforum@hsph.harvard.edu

If you are unable to attend the webcast tomorrow, a recording of this event will be available next week and we will provide updates on the CTTI blog.

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.

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 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 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.

CTTI would like to welcome our newest member, the Crohn’s & Colitis Foundation of America (CCFA).

CCFA is an organization focused on research, advocacy, and patient support for those suffering from Crohn’s disease and ulcerative colitis. CCFA’s Senior Director of Patient Services, James Testaverde, will represent this organization on CTTI’s Steering Committee.

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 would like to welcome our newest members, Alexion Pharmaceuticals, Inc. and Pharmaceutical Research and Manufacturers of America (PhRMA).

Alexion Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and delivering therapies for patients with rare diseases. Alexion’s Vice President of Research and Development Quality, Coleen Glessner, will represent this organization on CTTI’s Steering Committee.

PhRMA is a non-profit membership association that represents the country’s leading pharmaceutical research and biotechnology companies. PhRMA’s Senior Director of Science and Regulatory Advocacy, Jocelyn Ulrich, will represent this organization on CTTI’s Steering Committee.

We are pleased to have these two new voices 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.

We are thrilled to announce that Mark McClellan, MD, PhD, has joined CTTI as chair of the executive committee. McClellan is a past FDA commissioner and administrator of the Centers for Medicare & Medicaid Services (CMS). He currently works at the Brookings Institution. He is familiar with CTTI’s mission and work given our respective efforts to help FDA on antibacterial drug development, approval pathways, active postmarket surveillance, and other projects. We are pleased to have someone with McClellan’s experience, leadership, and passion for improving clinical trials join our effort.

We are also delighted to share that John Alexander, MD, MHS, FACC, will join the executive committee representing Duke University. Alexander has already done great work as the Duke steering committee representative, and is excited to increase his involvement at the programmatic level. As a passionate clinical trialist who has spent time working with the PMDA and MHLW in Japan, Alexander will bring that additional international perspective as well.

Historically, as founding members of CTTI, Duke and FDA have named the co-chairs of the initiative, and those same individuals have served as co-chairs of EC. We are now separating these roles: McClellan will be the chair of the EC, and Alexander will join CDR Melissa Robb as co-chairs of the initiative. The three of them will work closely together, along with executive director Pamela Tenaerts, MD, MBA, and the executive committee, to provide strategic leadership for the organization.