Welcome to today's webinar, hosted by NIAID.
We would like to present to the scientific community and other stakeholders our vision
for the clinical trial networks that NIAID's Division of Microbiology and Infectious Diseases
will support in the years 2020 and beyond.
The purpose of this discussion is to outline some of the changes that we intend to make
in the next funding period for the sites and other structures that conduct our infectious
disease clinical trials.
We are presenting these plans now to obtain feedback from the scientific community, from
potential commercial partners, and from other stakeholders.
In today's discussion I am first going to provide a context for our plans for an improved
clinical trial enterprise by presenting the DMID mission.
Then I am going to touch briefly on the current status of the DMID clinical trial networks.
These include the antibacterial resistance network, currently known as the ARLG, the
Sexually Transmitted Infections Clinical Trials Group, and the Vaccine and Treatment Evaluation Units.
Then I'm going to describe our vision for the changes that we would like to implement
in the VTEUs and the rest of our network structure.
Lastly, I will lay out the timeline for specific milestones leading up to the funding awards
for these network structures in the year 2020.
The Division of Microbiology and Infectious Diseases is a division of NIAID.
We support basic translational and clinical research to prevent and treat diseases caused
by all infectious human pathogens, except for HIV.
That area of research is supported through our sister division, the Division of AIDS.
DMID has many pathogens to cover.
We set priorities based upon two main considerations: the public health imperative that a specific
pathogen or epidemic represents, and then secondly we weigh that public health imperative
with the scientific opportunities available at that moment.
For example, in 2016, public health officials had noticed babies in Brazil born with microcephaly
as depicted in the photo in the upper left of the slide.
NIAID and DMID rapidly prioritized our collective research agenda to develop and test vaccines,
diagnostics and therapeutics that could be applied to address the surprising epidemic
caused by the Zika virus.
Additionally, in past years, scientific priorities were shifted to address emerging MDR-TB epidemics
and Ebola virus epidemics.
The development of new scientific tools that provide an opportunity to address ongoing
challenges in a new way can also alter our clinical research priorities.
Our Vaccine and Treatment Evaluation Units, or VTEUs, have been in existence for more
than 50 years.
They have served as DMID's flagship clinical trials program.
In past years, trials conducted at VTEU sites provided the basis for licensure of the conjugated
pneumococcal vaccine, known as Prevnar, in children, the first live cholera vaccine,
or Vaxchora, for the protection of travelers.
They also established the safety and immunogenicity of tetanus toxoid and diphtheria toxoid, an
acellular pertussis vaccination in pregnant women.
The VTEUs also conducted trials that led to the inclusion of new vaccines in the strategic
national stockpile.
These included studies of BioThrax, an anthrax vaccine, that showed that the vaccine could
be effective at reduced doses, and additionally the VTEUs showed that the first experimental
H5N1 avian influenza vaccine was safe and immunogenic.
And these are only a few examples of their achievements.
The Sexually Transmitted Infections Clinical Trials Group is a collection of trial sites
operated by DMID and funded through contracts.
These sites conduct clinical trials focused on the prevention and treatment of sexually
transmitted infections.
The group recently completed a clinical trial testing the efficacy of zoliflodacin, a new
antibiotic, at curing uncomplicated gonorrhea infection.
The group has also tested point-of-care diagnostics for the detection of other sexually transmitted
infections.
They conducted a clinical trial that demonstrated that azithromycin was not non-inferior to
doxycycline in treating chlamydial infection.
Summarized on this slide are the capabilities and needs that we envision for our future
clinical trials infrastructure.
We need an open system that brings in the best ideas.
We need a system that has global capability that can surge to open new sites in a location
where a new epidemic might emerge.
We need flexibility and funding structures that support collaborative partnerships with
other NIAID divisions.
We need the capability to do all phases of clinical trials; we expect that larger and
later stage clinical trials will be done through collaborative partnerships.
In the next generation of VTEUs, there will be new components to our clinical trial infrastructure.
The specific activities, and the roles of these components, and their interface with
DMID staff roles are described on this slide and those slides that follow.
We plan to implement a leadership group that will be responsible for generating clinical
trial protocols responsive to DMID's priorities.
This leadership group will form collaborative working groups and specialized areas of science.
These groups will focus on developing concepts for the most promising approaches to preventing
or treating Infectious disease, and they will develop protocols based upon these concepts.
They will recommend the best sites for protocol implementation, organize network planning
meetings, support the single institutional review board submission process, and determine
the cost per participant for a given protocol.
DMID's staff will interface with this leadership group by participating on protocol teams,
approving site selection, reviewing protocols for implementation, and fulfilling the role
of sponsor for studies conducted under an investigational new drug application.
We plan to modify and improve our clinical trial infrastructure in the next funding period.
The changes we envision are depicted in the schematic figure on this slide.
We plan to fund two separate components of this VTEU clinical trials network.
The leadership group operations center, with roles and responsibilities listed in the dark
blue circle, and the fixed sites, or the VTEUs, will implement the clinical trials developed
in the operation center and will also receive funding from NIAID.
There may be additional needs for protocol-specific sites funded through subcontracts.
In the future, we anticipate that the scientific priorities currently address for the STI CTG
and the current VTEUs can be supported through a single leadership group that will be linked
to VTEU sites.
We envision that this group will bring the best ideas from the extramural community to
design clinical trials that address DMID's scientific priorities.
The group will have the capability to subcontract with protocol-specific sites as the need arises
to recruit populations outside of the fixed network of sites.
We believe that a clinical trials infrastructure that is aligned with those of other NIAID
divisions in its funding structure will allow for better collaborative partnerships across
all of NIAID.
This slide summarizes the role and capabilities of the funded VTEU sites.
These sites will be able to recruit and retain normal healthy volunteers that span all ages
and will include the capability to recruit pregnant women.
Sites will be required to demonstrate that they are capable of implementing clinical
trials under an IND.
We will expect that their principal investigators have the capability to contribute to the scientific
agenda of the leadership group.
The portfolio of capabilities that DMID will require in the next funding period will include
the ability to recruit those with risks for sexually transmitted infections, the capacity
to conduct human challenge studies, including malaria challenge trials, and the capacity
to conduct pharmacodynamic and pharmacokinetic studies.
We don't anticipate that each site will need to have every capability listed, but we do
expect that these capabilities will be present in the collection of sites that we ultimately
choose to fund.
Based upon the cost per protocol participant enrolled and followed, which will be determined
by the leadership group, the sites will receive protocol funds from NIAID on a semi-annual basis.
These funds will be in addition to the fixed base funds that they will receive.
Depicted on this slide is our timeline for moving forward with these initiatives.
We will present our initiatives to fund the leadership group and VTEU sites to our Advisory
Council in open session in June.
Then we will develop our funding opportunity announcements which we will expect to publish
in the fall of 2018.
We planned out a webinar shortly after the announcement is released to address further
questions from the scientific community.
We expect that there will be at least six months between publication and receipt date.
A special emphasis panel that will review applications will meet in the summer of 2019
and we plan to make awards in the first quarter of fiscal year 2020.
Finally, we have created an email group and are happy to receive your questions about
our proposed changes.
We will create a frequently asked questions site on the NIAID website.
We'll keep it current with new FAQs as they arise during the planning period.
Thank you.