Lisan Parker was on hand at the Town Hall Meeting to Examine the Restructuring of the NIH/NIAID Clinical Trials Networks for HIV/AIDS & Other Infectious Diseases and filed this report:

The morning talks began with Dr. Anthony Fauci explaining the current structure of the NIAID clinical trial network which has been a highly successful network to date for HIV/AIDS clinical studies. He described how we can work together to create a new clinical network that will have the capability for the study of ALL infectious diseases. The current funding cycles for existing HIV/AIDS networks is ending 2013-2014. About 18 months ago, NIAID began exploring and evaluating the use of the clinical trial network to support the study of other infectious diseases, TB for well. In 2009, NIAID convened clinical research consultation in 2009 for the 2010-2020 time frame of future clinical research. The major highlights:

• develop multi-disease capacity and capitalize on successful HIV/AIDS clinical trial network
• must be flexible
• incorporate new expertise
• increase IRB efficiency

NIAID will be expanding in 3 components:

1. HIV/AIDS- current AIDS clinical trial network- note: HIV/AIDS funding is a line item written into the law, whereas other diseases funded on scientific needs.
2. AIDS co-morbidities (already initiated)- TB, Hepatitis B, Hepatitis C- modified AIDS clinical trial network. This component can use AIDS money in this component.
3. Non-AIDS infectious disease- expand scope of current NIAID clinical trial network (paid for by non-AIDS money).

a. Potential non-AIDS infectious diseases:

i. Antimicrobial resistance

ii. Malaria

iii. Neglected tropical diseases

iv. Influenza

v. Emerging/re-emerging infectious disease

A research group will be put together in the upcoming RFAs.

Of important note, regarding funding, there are two types of ‘new’ money: more ‘new’ money added or ‘new’ money repurposed from another project; funding for this restructuring is not new additional money but money repurposed to other projects

Carl Dieffenbach then spoke specifically about the Division of AIDS (DAIDS). Essentially, TB was first evaluated for clinical trial investigation as an HIV co-morbid disease, followed by the evaluation of other infectious diseases. The restructured network is more targeted to scientific ideas and priorities will drive the clinical research. Community involvement and engagement is significant. Clinical sites will be added were needed and reduced where not effective. Funding for clinical networks is on a 7 yr cycle. The ‘best science’ is needed to drive infrastructure. , and

Four priority HIV request for applications (RFAs) are being generated. They will be:

• Vaccine- e.g.Phase I-III, immune response studies
• Therapeutics- e.g. non-infectious co-morbidities, cure/functional cure, therapeutics for hepatitis, therapeutic strategies for TB
• Prevention- e.g. microbicides, prophylaxis
• Pediatrics/Maternal- e.g. vaccines, cure, co-infection/ co-morbidity, consequences of ART, pharmacology/drug formulation, prevention

The 2013 Network Structure will be composed of three leadership groups, including strategic working groups (strategies) and operational working groups (implementation). Release of RFAs will begin early CY 2012, 6 months plus to submit, then applications reviewed, and awards announced by the end of 2013.

The new differences are that there will be four RFAs vs. one RFA and scientific priorities have evolved.

The Blog for AIDS division can be viewed here: http://blog.aids.gov

Carole Heilman then discussed how non-HIV/AIDS infectious diseases will be considered in the new clinical structure. First, she presented an overview of the Division of Microbiology and Infectious Diseases (DMID). From FY05 to present, 115 out of 293 pathogens are covered. Approximately $240 million/yr given for research. There are 770 clinical projects, 42% of which have international components.

The fifth RFA that will go out in CY 2012 will be from the Non-AIDS infectious disease leadership group

At present, the top ten funded diseases for FY07-09 are:

1. Influenza >$100 million
2. Antimicrobial resistance ~$70 million
3. Malaria ~$70 million
4. TB ~$60 million
5. Smallpox
6. West Nile
7. Hepatitis C
8. Dengue
9. Cytomegalovirus
10. Chlamydia

Manizhe Payton then presented the four goals in restructuring the clinical trial networks:

1. flexible clinical trials
2. multiscope clinical trial unit (CTU)
3. efficient/effective utilization of resources and cost containment
4. continual development in research limited international settings

There will be fewer CTUs with increase in clinical research sites (CRS). The goal is to have ~25 CTU with ~4-8 CRS. All will perform HIV/AIDS research, and some will perform non-HIV/AIDS research trials. There will be shared resources, and increased co-administration capacity.

2 types of clinical trials are proposed:

• CRS (stable)
• Protocol-specific sites (surge capacity), i.e. depends on protocol

Opportunity for multiple principle investigators (PI) does exist in the restructured paradigm. Advocacy for local needs and priorities will be based on the population where the studies are conducted.

This restructure will institute:

• a transparent system for funding and oversight
• a consortium agreements setup
• core funding adjusted based on performance data- develop/implement a performance evaluation system

The afternoon talks focused on utilizing the clinical trials infrastructure- Division of Intramural Research (DIR), NICHD, NIMH, NCI, NIDCR are all institutes that have HIV related work and currently demonstrate opportunities to collaborate.

The Division of Extramural Activities discussed the changes that have occurred in funding grants since 2006.

Points to consider when applying for funding:

1. think strategically
2. respond to requirements of the FOA i.e. ‘Read it’
3. follow restructured format
4. respond to review criteria and additional FOA criteria
5. write in response to review criteria
6. keep in mind that there are no subscores, there is one score for network
7. need to address/demonstrate how proposal will work
8. choose partners wisely
9. page limits
10. appendix material limits
11. do not include unnecessary names/institutions
12. do not put consultants who do not have precise involvement in project

Separate special emphasis panels (SEPs) for each RFA response.

Make proposals clear, concise, and quick ‘to-the-point’.

Q/A sessions Major Points:

• money/funds on research not infrastructure
• will not take money from R01 pool but from initiatives that are turning over
• request to build in injury insurance
• CTSA issues
• International TB pediatric agenda mentioned
• ‘What is a site?’ office were records are kept?…not necessarily the same clinic where patients are seen, can be different hospitals
• suggestion made to incentivize good CRSs to collaborate
• CTUs for a region was a suggestion
• Examined where current geographic presence needed to determine number of CTUs
• Foreign CTUs acceptable
• Multiple PIs not the same as co-PI; multiple PIs mean equal responsibility for research

Summary

The restructuring of the NIAID clinical sites has been developed and shared, however discussions are ongoing for many of the implementation specifics, e.g. how will the current sites be impacted, maintained, transitioned, impact of loss, collaboration, RFA drafting and release, and most importantly funding, how applications will be reviewed, funds dispersed. Input is being requested.

8:30 a.m.–8:45 a.m. Introductory Remarks

• Anthony S. Fauci, M.D., Director, NIAID

8:45 a.m.–9:45 a.m. Panel 1: Restructuring of the NIAID HIV/AIDS Clinical Trials Networks

• Moderator:
  Hugh Auchincloss Jr., M.D., Deputy Director, NIAID

• Expectations of the Restructuring
  Carl W. Dieffenbach, Ph.D., Director, Division of AIDS (DAIDS), NIAID

• Expanding the Scope of the Networks
  Carole Heilman, Ph.D., Director, Division of Microbiology & Infectious Diseases, NIAID

• Clinical Trials Units and Clinical Research Sites
  Manizhe Payton, Director, Office of Clinical Site Oversight (OCSO), DAIDS

• Additional Panel Members:
  – Margaret I. Johnston, Vaccine Research Program, DAIDS
  – Carla Pettinelli, Therapeutics Research Program (TRP), DAIDS
  – Sheryl Zwerski, Prevention Sciences Program, DAIDS
  – Ed Handelsman, Pediatric Medicine Branch, TRP, DAIDS
  – Maureen Power, Asia and the Americas Branch, OCSO, DAIDS

9:45 a.m.–11:30 a.m. Questions & Answers

11:30 a.m.–1:00 p.m. Lunch (on your own)

1:00 p.m.–2:00 p.m. Panel 2: Opportunities for Collaboration

• Moderator:
  Robert Eisinger, Ph.D., Director of Scientific and Program Operations, Office of AIDS Research, NIH

• Opportunities for Collaboration with the NIAID Division of Intramural Research
  Kathryn Zoon, Ph.D., Director, Division of Intramural Research, NIAID

• Research Interests and Opportunities for Collaboration with the:

• Eunice Kennedy Shriver National Institute of Child Health and Human Development
  Lynne Mofenson, M.D., Chief, Pediatric, Adolescent and Maternal AIDS Branch, NICHD

• National Institute of Mental Health
  Dianne Rausch, Ph.D., Deputy Director, Center for Mental Health Research on AIDS, NIMH

• National Cancer Institute
  Robert Yarchoan, M.D., Director, Office of HIV and AIDS Malignancy, NCI

• National Institute of Dental and Craniofacial Research
  Isaac Rodriguez- Chavez, Ph.D., Director, AIDS and Immunosuppression Program, NIDCR

• Additional Panel Members:
  Andrew Forsythe, NIMH
  Bill Kapogiannis, NICHD

2:00 p.m.–3:00 p.m. Questions & Answers

3:00 p.m.–3:15 p.m. Break

3:15 p.m.–4:15 p.m. Panel 3: The Application and Review Process

• Moderator:
  Marvin Kalt, Ph.D., Director, Division of Extramural Activities (DEA), NIAID

• Strategies for Reviewing Large, Complex Applications
  Hortencia Hornbeak, Ph.D., Director, Scientific Review Program, DEA

• Questions for DEA
  Mary Kirker, Chief, Grants Management Branch, DEA

4:15 p.m.–5:25 p.m. Questions & Answers

5:25 p.m.–5:30 p.m. Closing Remarks

• Hugh Auchincloss, Jr., M.D., Deputy Director, NIAID