Multi-Center Network for Outcomes Research in HIV Pharmacotherapy

Antiviral Clinical Pharmacology Unit Department of Pharmacy Practice School of Pharmacy and Pharmaceutical Sciences University at Buffalo

Clinical Research Recently Presented Research Posters

Goal:

• To establish a network of clinicians capable of conducting multi-center research in HIV Pharmacotherapeutics
• Potential areas of investigation:
  • Pharmacokinetics - drug interactions
  • Outcomes Research - pharmacoepidemiology
  • Pharmacoeconomics - quality of life research
  • Adherence Research - adverse drug reactions
  • Validation of clinical tools
  
  

Infrastructure:

• HIV Pharmacotherapy Website to be used for site registration, data collection/storage, statistical support, and dissemination of clinical information
• Rigid data-entry criteria requires upfront work, but will save time in long run
• Site Registration/Survey:
  • Principle Investigator at each site
  • Summary of patient Demographics
  • Feasibility Information for Medical Record Access
  • Description of pharmacotherapy services
  
  

Research Board:

• Site Registration and Approval
• Review of study proposals
• Review of publication of results to ensure lack of bias in reports

Financial Issues:

• Industry sponsorship of concept sheets will be encouraged, although not required
  • unfunded projects will require volunteer time on the part of Principle Investigator
  • Previous volunteer work will increase priority for funded projects at a later date
  
  
• Fiscal matters may be handled 2 ways:
  • Administered via the Network homebase (UB)
  • Administered via the Institution of a Registered Principle Investigator
  
  
• Indirect Cost for use of Network (~25%)
• Compensation for medical record review and data input into CRF will be standardized at a rate of $50-$100 per chart

Pilot Phase:

• Prototype Project:
  • Cross-sensitivity between Amprenavir and Trimethoprim-Sulfamethoxazole in HIV Patients (ACPU 121)
  
  
• Create infra-structure of network and On-line Case Report Form
• Network available to pharmaceutical industry or other investigators
• Apply for peer-reviewed grant funding

Immediate Financial Needs:

• Honoraria for Review Board members:
  • 5 x $1000 each/year
  
  
• Database development:
  • 16 hours of consultant time at $100/hour
  
  
• Time spent training Network support staff to learn to manage database
• Total to initiate pilot phase:
  • $6600 for first year
  
  

Implementation of ACPU 121:

• Mark and Nancy met with Diane White (Microsoft Access consultant) on 1/22/01
  • next meeting 2/19/01
  
  
• Established basic fields and tables for data to be used in the project:
  • PI registration - used for all projects
  • Site registration- used for all projects
  • Include survey of scope of Rx practices in HIV
  • Subject registration - used for all projects
  • Protocol Case Report Form - specific projects
  
  
• Created a nice "pull down" table containing both generic and trade names for medications:
  • Antiretrovirals
  • Other medications
  
  
• Need to continue to specify all fields and criteria for these fields in the CRF (Mark Shelton will prepare these items)
• Excellent example recently published of similar project that "networked" three sites
  • Bersoff-Matcha SJ, et al.  Sex differences in nevirapine rash.  CID. 2001;32:124-9
  • plan to contact authors to see if they will share their data collection form
  
  
• Draft a letter to members of the research board:
  • outlining their responsibilities
  
  
• Website questions:
  • how will the website interact with Access?
  
  
• Direct interaction vs. download in textformat
  • what machine/platform is the website running on?  UNIX vs. Windows NT
  • Diane White indicates that the "forms" for data entry will need to be created within the website, but the tables can be generated in Access
  • if all criteria and field characteristics are defined in Access, it will be easier for the webmaster
  • At website 1/25/01 meeting, there was discussion re: format for data-entry at sites: 
  • data entered at sites into Access-based program provided by Website and then emailed to website for combining with other data
  • faster, sites would retain their own data
  • data entered at sites directly into the website:
  • slow speed, allows site access to their own data
  • Subject numbers remain an issue:
  • assignment, prevention of duplication
  
  

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