International Maternal Pediatric Adolescent AIDS Clinical Trials Group Site Resource Committee Goals and Accomplishments

The mission of the Pediatric Site Resource Committee (PSRC) is to provide clinical and technical expertise to the PACTG on perinatal, pediatric and adolescent patient care, protocol development and implementation, and site and data management issues as they relate to the conduct of clinical trials through the work of its committees.  The three working groups of the PSRC are Patient Care, Site Operations, and Field Representatives and are comprised of Study Coordinators, Research Nurses, Data Managers and other site staff.  The PSRC directs the activities of the three working groups to ensure that their efforts are coordinated and that the groups respond to the needs of the PEC.  Committee membership consists of site staff from NIAID and NICHD sites. 

 2004 Accomplishments

        1.          Regional Trainings:

The Pediatric Site Resource Committee received $15,000 in discretionary funding from the PEC in August of 2003 to expand the established, highly successful AACTG Regional Training program to include a pediatric component.  The PSRC in collaboration with the AACTG Site Resource Committees and FSTRF conducted the first joint Regional Training Program in Puerto Rico in October, 2003.   Based on the success of the first Regional training program, a second Regional Joint Regional Training Program was presented in Chicago, May 16-19^th. 

The Regional Training agendas were responsive to educational needs identified by site staff, with particular emphasis on addressing PACTG operational issues and enhancing site performance.  The complexity of the PACTG, the amount of time required to train new staff, as well as the disruption to daily working routines while orienting new staff were common challenges identified by PACTG sites and identified as high priority areas to address through trainings. The pediatric components of the program were developed and presented by PSRC members.  Core to all training sessions was an emphasis on the PACTG agenda priorities, with special emphasis on open and pending treatment and adolescent protocols, recruitment and accrual concerns, quality in data management, CAB development and support, and site staff opportunities for participation in the PACTG committee and protocol teams.    Both the Puerto Rico and Chicago Regional Trainings were highly rated by participants, exceeding expectations in all categories.   Registration for each training was limited to a total of 100 participants, half from pediatric sites.  Pediatric site staff attendance was supported by PI’s, with equal attendance of both NIAID and NICHD funded site staff.

2.          PACTG Group Meeting Trainings:
The PSRC coordinated a staff training retreat day at the August 2004 PACTG meeting, attended by approximately 120 site staff.  All sessions were highly rated, receiving evaluation scores of greater then 4/5.  CEU’s were awarded for attendance at this training.

Topics presented included: 

·         An interactive session between the site monitoring group and sites to clarify the purpose of site visits and expectations of both individual sites and monitors during monitoring visits.   The sessions were designed to be interactive and collaborative, and addressed frequently encountered problems and concerns identified by both site personnel and monitors.

·        FSTRF presented an overview session highlighting available web-based tools available to all sites. 

·        A panel of international site staff presented discussed challenges and barriers to conducting research studies at international sites

·        The laboratory technologist group provided an overview of the LDMS system and implications for clinical site personnel. 

In addition to the Site staff training retreat, PSRC members conducted a P1045 specific-training session for site personnel to assist in obtaining the skill certification required for protocol participation. Following this session, enrollment into the P1045 protocol increased substantially with the increased number of certified staff.

3.           The PSRC has continued to develop one-page protocol specific information sheets for participants to be used for recruitment purposes.  These information sheets are reviewed and approved for use by protocol teams prior to general distribution.  Protocol teams, the CCG and local CAB’s and IRB’s have expressed enthusiasm for these brief recruitment and educational tools.  To date, 15 protocol specific information sheets have been finalized and approved by study teams with an additional 5 information sheets in development.  

4.          The PSRC has consulted with the 219C team regarding issues related to retention of participants in long-term studies.  In response to a request from the ACTG 219C team, the PSRC met with ACTG 219C team members to discuss the problem of retention and to develop a survey to identify specific retention issues.   As issues are identified, the PSRC is poised to develop educational and retention support to PACTG sites. 

5.          The PSRC has worked collaboratively the with Operations office to develop Protocol specific web pages.  The Protocol Specific Web pages have been developed in response to an identified need by site staff for easy access to current protocol-related documents. 

6.          PSRC continues to actively work with the PACTG Operations Center to address issues related to:  1) the complexity of language on consent forms, 2) the dissemination of Protocol-specific patient information sheets and 4) the availability of DSMB reports needed for IRB submissions.

7.        The PSRC members continue to offer support for and training for international site staff.  Currently there are 2 international members on the PSRC representing issues specific to international sites.  The PSRC remains available and committed to assisting International sites with all aspects of research protocol conduct.  

8.        The PSRC continues to maintain and manage a mentoring program for

domestic sites.  New PACTG staff are referred to the PSRC's mentoring program by the DMC and are matched with an experienced data manager, research nurse or study coordinator.  This formalized mentoring system has allowed new staff the opportunity to learn from other site personnel in similar roles, diminishing stress during the orientation period of new staff and enhancing quality of data and site management throughout the PACTG.  

9.          PSRC members along with the DMC have provided on-site mentoring and training to sites experiencing declines in performance due to staff turnover.  PSRC support continues to be instrumental in improving performance at the supported sites.

10.       PSRC members serve as “voting “members/liaisons to all of the Research Agenda Committees, the PES Subcommittee, SES, Adherence to Therapy and major working groups.  There are 37 PSRC members who are Field Representatives on Protocol Teams in the PACTG.  The PSRC members participate in conference calls and work on projects with these committees, adding field and operational expertise when needed.  In addition, the PSRC chair serves as a voting member of the PEC and the ex-Officio chair serves as a non-voting member of the PEC.

11.       The PSRC continues to maintain a website to disseminate information to PACTG sites regarding the ongoing activities of each of the 3 PSRC working groups:  the patient care working group, field representative working group and the site operations working group.

WORKING GROUP UPDATES

A.     The Patient Care Working Group has created Patient Education Handouts for over 10 protocols in the field and is planning new educational handouts for protocols in development in collaboration with field representatives on the protocol teams.  A standard protocol has been developed for posting the protocol-specific information sheet on the protocol-specific Web page.

B.     The Field Rep Working Group has 37 members who serve as Field Reps on protocols.   62 Protocols have had Field Rep participation.  The Field Rep Working Group held a PACTG Field Rep Training on August 4 at the PACTG meetings at Crystal City.   A joint adult pediatric Field rep training was conducted during the Dec 2004 PACTG meeting.  A joint Adult/Pediatric Field Rep training manual is currently in development.

C.     The training included the PACTG protocol development process, the role of the Field Rep, enhancing the effectiveness of the Field Rep, Field Rep lists and assignments, and web page access to useful tools and the mentor program.  CEU’s were awarded to participants who attended.  Forty-four attended the training from 31 PACTG sites, including both domestic and International sites, DAIDS, PPD, DMC, CAB’s and OPS.  Evaluations indicated high approval and requests for future Field Rep Trainings.

D.  The Site Operations Working Group continues to work with the DMC to develop and test new programs.  Input from the committee has led to the development of a “patient transfer” program and working group members serve on the focus group for the new EData data entry system.  The Site Operations Working Group is currently working on the updating of site tools such as the study coordinator checklist and members are working with the Operations Center on developing an International Training Manual.  PSRC members have participated in on-line AER beta-testing program.

PSRC GOALS For 2004-2005

·               Coordinate and facilitate PACTG Site Staff Trainings at PACTG meetings including DAIDS & Regulatory updates to include:

·         Protocol Field Representative Trainings

·         Protocol specific trainings

·         Regulatory and Site Operations issues.

·               Collaborate with DMC and AACTG to provide Joint Regional Trainings to PACTG Site Staff personnel.  The next Joint Regional Training is planned for Cincinnati in Spring 2005

·               Maintain PACTG Research Agenda Committee (RAC) and PEC committee participation.  

·               Continue Resource subcommittee and CAB liaison memberships.

·               Begin site level collaborations between the PACTG and perinatal HPTN networks   to facilitate the integration of the two networks into the IMPAACT group.  Provide site resource supports as issues and needs are identified to enhance the merger.  Coordinate with HPTN site personnel to identify joint training and educational needs.

·               Develop protocol patient/parent educational handouts specific to each PACTG/AACTG/ATN protocol to be posted concurrently with version 1 of the protocols

·               Provide collaborative PSRC support to UMDNJ and FXB in planning and conducting International site and staff trainings for local PACTG protocol implementation

·               Assist in the recruitment and training of START teams for international protocol implementation.