# Presentation: 228068

## Conducting Multi-Site Collaborative Studies

- Lessons Learned and Their Implications for Assessing the Impact of Childhood Interventions on Subsequent Drug Abuse

-  May, 2000

- Audrey Smith Rogers, NICHD

## Some Funding Mechanisms

- Unsolicited RO1s
- Request for Applications (RFA)				-solicited RO1s							-solicited UO1s
- Program Announcements (PA)

## Situations in which multi-site research may be indicated

- Need a large number of study subjects			- arising from study question or				- required to address loss-to-followup
- Cases rare
- Geographic distribution important to the question
- Need adequate numbers of important subgroups
- Benefit to having broader scientific expertise

## The UO1

- A cooperative agreement supporting a discrete, specified, and circumscribed research project

## Two Approaches to UO1s

- Same Theme
- Common Objective
- Independent Studies
- Cross-fertilization

- Same Theme
- Common Objective
- Common Base Protocol
- Collaborative Work

## Collaborative Work / Base Protocol

- Scenario One								Individual investigators 					who have access to subjects of interest											Challenges								May but does not always include the best 		theoreticians or scientists

## Collaborative Work / Base Protocol

- Scenario Two								-Basic Science Investigators with individual 		hypothetical proposals					-Investigators who have access to subjects	Challenges								-Establish harmony to produce base study		-And do so in timely manner				-Establish harmony with clinical investigators

## Collaborative Work / Base Protocol

- Scenario Three							-Principal Investigator and Leadership Group 	with necessary credentials and plan to achieve 	project objectives, competing with others		-Investigators who have access to subjects	Challenges								-Establish harmony with clinical investigators

## Harmony with Clinical Investigators:Some possible problems

- Investigators with clinical access to at-risk populations are stressed with the provision of under-funded health services
- Concerns about the balance of wearing two hats: care-giver and study director
- Little expertise in study design and limited experience in implementing clinical research

## Harmony with Clinical Investigators-Some possible solutions

- Investigators need to be involved in the schedule of assessments in order to produce a protocol that will not inordinately burden the subjects or staff
- Investigators need the opportunity to discuss health care issues within the research setting and to be heard and supported in balancing demands
- Research mentoring- formally and informally

## Multi-site Research Challenges

- Agreement on specifics of protocol				e.g. Nature and frequency of measurements
- Provision of appropriate executive function		viz. response to crises and poor performance
- Training and standardization
- Site monitoring
- Real-time and effective communication
- Pro-active planning

## Multi-site Research Challenges

- Program issues								-Presence and involvement 					-Targeted, tailored funding					-Effective management of resources 			-Assessment and solicitation of  				productive consortium arrangements			-Creative thinking, stressing possibilities

## Multi-site Research Challenges

- Subject issues								-Safety								-Recruitment							-Retention									-Tracking								-Services								-Compensation						-Information and feedback					-Community Advisory Board Representation

## Multi-site Research Challenges

- Institutional issues							-Institutional Review Board					-Provision of adequate ancillary services		-Supply of necessary clinical support staff		-Establish comfortable, friendly environment

## Multi-site Research Challenges

- How to accommodate emerging scientific issues		-Expand internally: Supplemental funding 		for specific proposals 						-Expand externally: Collaborate with 			investigators in applying for RO1s or 			responding to PAs						-New mechanism: the discretionary research 	fund in cooperative agreements