Despite the financial reward, opportunity to enhance patient care and the opportunity to contribute to medical advancement that General Practitioners (GPs) can be rewarded with by participating in Clinical Trial, balancing research with daily clinical responsibilities can be challenging. By collaborating as a unified research site, multiple GP practices can pool resources, expand capacity, and streamline trial participation. This blog explains how to structure such a partnership.
Benefits of a Unified Research Model
- Increased Capacity: Recruit more patients across diverse demographics. Larger catchment area to recruit from
- Shared Resources: Reduce administrative burdens by centralising tasks like, ethics submissions or data management.
- Funding Access: Attract larger scale trials, leading to higher revenue potential.
- Professional Development: Upskill staff collectively in research methodologies.
- Enhanced Patient Care: Offer cutting-edge treatments and contribute to evidence-based medicine.
Structuring the Partnership:
Multiple General Practitioner (GP) practices can collaborate to establish a unified research site, regardless of their geographic location, by adopting the hub-and-spoke framework. This model optimizes collaboration, resource allocation, and operational efficiency in research activities.
Framework Structure:
- Lead Practice (Hub): The Principal Investigator (PI) must affiliate with the hub. The hub serves as the central coordinating entity, responsible for:
- Managing the Clinical Trial Agreement (CTA) and sponsor relationships.
- Overseeing regulatory compliance, including adherence to MHRA and NHS Ethics.
- Spoke Practices (Satellite/Referral Sites): Spoke practices function as decentralized research sites connected to the hub. Their responsibilities include:
- Patient recruitment and data collection in their local settings.
- Conducting localised research activities while adhering to the hub’s guidance.
- Maintaining a degree of operational autonomy within the structured framework.
This model enhances research capacity, ensures regulatory compliance, and facilitates efficient multi-site clinical trials.
Clinical Trial Agreement (CTA) Setup
- Single Agreement vs. Multiple Agreements with sponsor: Most sponsors prefer a single CTA with the lead site, simplifying negotiations. A separate sub-agreement will need to exist with all the satellite sites operating under the Hub umbrella. Alternatively, practices may form a legal consortium to sign a joint CTA but this option is less preferred by sponsors.
Defining Roles
- Lead Site: Principal Investigator (PI) responsibilities, regulatory submissions, and sponsor communication.
- Satellite Sites: Patient recruitment, follow-ups, and data collection, adhering to the lead site’s SOPs and study protocols.
Payment Distribution
- The lead site receives trial funds and distributes payments transparently based on each practice’s contribution (e.g., per recruited patient) or any pre-established term in the sub agreement.
Liability and Insurance
- Lead site typically assumes primary liability, but all practices require indemnity coverage. Legal counsel is essential to clarify responsibilities.
Data Management
- Centralised systems ensure consistency. Satellite sites input data into shared platforms, with the lead site auditing for quality.
Satellite Vs Referral Sites
Both Satellite Sites and Referral Sites operate under the hub-and-spoke model but serve distinct roles in research studies. They both operated under the Lead Site’s(Hub) CTA. Satellite Sites play an active role in research execution, while Referral Sites primarily support recruitment by directing potential participants to research-active sites.
| Aspect | Satellite Site | Referral Site |
| Definition | A fully participating research site that conducts trial-related procedures. | A site that identifies and refers eligible patients to the main research site but does not conduct study procedures. |
| Patient Interaction | Direct involvement in patient care, data collection, and trial activities. | Limited to patient identification and referral to the hub or a satellite site. |
| Regulatory Oversight | Requires approvals (e.g., MHRA, NHS Ethics) and follows full trial protocols. | Minimal regulatory oversight as it does not conduct research procedures. |
| Infrastructure | Must have trained research staff and facilities for trial execution. | Requires minimal infrastructure, mainly for patient screening and referral coordination. |
| Level of Autonomy | Operates under hub guidance but actively conducts research. | Works in a supportive role, with no independent trial activities. |
When establishing a partnership for a collaborative research site, the following factors must be taken into account:
- Standardised Training: The lead (hub) site must have a documented process in place for providing protocol training to satellite sites. This ensures consistency and uniformity across all locations.
- Communication Framework: Regular meetings and shared digital tools (such as Slack or NHS Mail) should be implemented to maintain alignment among all parties involved.
Steps to take to establish the hub-and-spoke framework:
- Form a Consortium: Align interested practices with a shared research vision.
- Develop a Legal Framework: Draft a collaboration agreement covering roles, payments, and dispute resolution.
- Engage Sponsors/CROs: Highlight your collective capacity in bids. Biopharmaal can assist with sponsor negotiations and sourcing for studies.
- Train Staff: Centralised GCP training and trial-specific workshops.
- Launch and Monitor: Begin trials with clear KPIs and ongoing support from the lead site.
By uniting as a single research entity, GP practices can maximise their impact without overburdening individual teams. This model benefits sponsors through efficient recruitment and streamlined processes, making your consortium a preferred partner for future trial
Biopharmaal Consulting specialises in guiding GPs through every step—from structuring agreements to training staff. Contact us to transform your practices into a clinical research powerhouse.