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.
Author: Lorri Bingham
NIH Encourages the Use of Central IRBs in Multi-Site Clinical Trials and CTTI’s Tools Can Assist with Implementation
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
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
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.
CTTI Now Accepting Applications for Individual Patient/Caregiver Representatives
Are you a patient or caregiver who is passionate about improving the clinical trial process? Do you have an understanding of the clinical trial system and related regulations? Would you like to be involved with an organization that brings together the diverse stakeholders involved in the clinical trials enterprise to bring about positive change?
If you answered yes to these questions, you may be a candidate for the position of Patient/Caregiver Representative on the CTTI Steering Committee.
CTTI is now accepting applications, through December 10, 2014, for two individual Patient/Caregiver Representatives. Reps will each serve a three-year term, providing a patient voice in the activities and discussions of the CTTI Steering Committee and on project teams.
For more information about the application process, click here.
“Ultimately the remedy for our ailing clinical research system depends on the collective effort of all constituents involved in the clinical trials process; CTTI provides an optimal venue for this collaboration.”
-Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative
CTTI Among the Spotlighted Consortia Focused on Drug Development Challenges
The latest issue of Nature Reviews Drug Discovery highlights several consortia that have resulted from the FDA’s Critical Path Initiative, launched nearly a decade ago. CTTI is among these initiatives and was featured in the article, The Clinical Trials Transformation Initiative: innovation through collaboration.
This publication explains the crisis in the clinical trials enterprise and CTTI’s unique role in developing actionable solutions. Several CTTI project are highlighted, including Quality by Design, Central IRB, and Investigational New Drug Safety Reporting. For each of these projects, the authors identify the issue at hand and go on to explain CTTI’s efforts to implement recommendations, noting both the difficulties and imperative of creating cultural and organizational change. The authors also comment on the ability of CTTI’s evidence-based work to inform policy and practices in the interest of public health.
“By creating an environment of trust, we enable the stakeholders — representing all sectors of the enterprise — to think about practical solutions to the identified problems and to develop strategies to effect change.”
– Pamela Tenaerts, Leanne Madre, Patrick Archdeacon, and Robert Califf
CTTI Speaks to Patient-Centeredness & Innovation in Clinical Trials at Upcoming Partnering for Cures Conference
On November 16-18, 2014, FasterCures will host their 6th Annual Partnering for Cures conference in New York City. This meeting will provide a platform to bring “together leaders from all sectors in medical research with the express purpose of making collaboration happen – collaborations that must happen if we are to speed up the time it takes to turn discoveries into treatments and cures” (partneringforcures.org). If you are attending this conference, we encourage you to engage with CTTI at one of the following events.
CTTI AT PARTNERING FOR CURES 2014:
Event Type: Breakfast Affinity Roundtable
Topic: Rethinking clinical trials
Date & Time: Monday, November 17, 2014 at 7:00 – 8:00 AM
The goal of the Breakfast Affinity Roundtables is to jumpstart networking by organizing informal gatherings of conference attendees who have similar interests. CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be leading the informal discussion focused on innovative approaches to clinical trials.
Event Type: Plenary Panel
Topic: Putting the patients in ‘patient-centeredness’
Date & Time: Tuesday, November 18, 2014 from 3:30 – 4:30 PM
Bray Patrick-Lake will also be speaking at the Partnering for Cures Session that focuses on concrete efforts for patients to be at the center of the medical research system.
To view the conference agenda, along with session descriptions, click here.
If you are on Twitter, we invite you to join the conversation:
- Conference Hashtag: #P4C2014
- CTTI’s Handle: @CTTI_Trials
- Bray Patrick-Lake’s Handle: @BrayPatrickLake
Results of CTTI’s GCP Training Project Featured at NCATS Meeting
The first of two working meetings for the Enhancing Clinical Research Professionals’ Training and Qualifications project took place earlier this week in Chicago, IL. At this national conference, CTTI’s Executive Director Pamela Tenaerts presented CTTI Findings and Recommendations for GCP Training, based on our GCP Training Project.
The primary goal of this first meeting [was] to achieve consensus in identifying a standardized training platform in Good Clinical Practice (GCP) and the necessary means to disseminate it across all consortium sites. (ctsacentral.org)
The Enhancing Clinical Research Professionals’ Training and Qualifications project is supported by a National Center for Advancing Translational Sciences (NCATS) supplement award and serves the Clinical and Translational Science Award (CTSA) consortium.
Ethicist Dr. Felix Gyi Remembered for his Commitment to Human Subjects Protection
We are saddened by the unexpected passing of Dr. Felix A. Khin-Maung-Gyi, executive chairman and founder of Chesapeake Research Review LLC.
Dr. Gyi’s contributions to CTTI and the greater clinical trials community will not be forgotten. As an ethicist specializing in clinical research, he was both well respected and passionate about human subjects protection. In addition to establishing Chesapeake IRB, he also served as a member of CTTI’s Steering Committee and was instrumental in spearheading CTTI’s Central IRB Project as a team lead.
The CTTI staff send our condolences to Dr. Gyi’s family, friends and colleagues.
“Felix Gyi will be remembered at CTTI for his enthusiastic efforts to catalyze our first IRB Project. We will all miss his passion and contribution to the clinical trials community.”
-Pamela Tenaerts, CTTI’s Executive Director
CTTI Highlights Multi-stakeholder Perspectives in Drug Development at Upcoming Clinical Investigator Course
On November 4 – 6, 2014 the FDA’s Office of Medical Policy and the Duke School of Medicine will co-sponsor the Sixth Annual Clinical Investigator’s course in College Park, MD.
This extensive 3-day course focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA’s regulatory requirements related to the performance and evaluation of clinical studies. (fda.gov)
During this event, CTTI will be represented in the Session 6 Roundtable titled The Clinical Investigator’s Role in Drug Development: a multi-stakeholder perspective at 2:15 pm on Thursday, November 6. To view the agenda for the entire program, click here.
We look forward to connecting with our colleagues at this event.