How Long Does It Take to Set Up a General Practice as a Research Site?

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Establishing a General Practice (GP) as a clinical research site presents a valuable opportunity to deliver new treatments to patients, generate additional revenue, and contribute meaningfully to advancements in medical science. However, this undertaking requires meticulous planning, adherence to regulatory standards, and the development of appropriate infrastructure.

This article outlines the steps involved in this transformation, along with the required timeline and human resource.

Average Timeline for Setup

The duration required to achieve research site readiness at a practice can vary significantly based on several factors, including existing infrastructure, staff availability, and the complexity of the proposed studies. On average, the timeline is as follows:

  • 6 to 12 months: For a GP starting from ground zero.
  • 3 to 6 months: For a GP with prior clinical research experience or infrastructure in place.

Let’s break down the setup process into distinct steps.

Step 1: Feasibility Assessment (1–2 Months)

Before initiating the setup process, it is crucial to determine whether the GP is equipped to conduct research. This assessment should encompass:

  1. Patient Demographics: Analyzing whether the patient population is suitable for clinical trials.
  2. Infrastructure Review: Identifying if adequate facilities, such as private consultation rooms and equipment for sample collection, are available.
  3. Regulatory Understanding: Ensuring the staff is knowledgeable about research guidelines, particularly Good Clinical Practice (GCP).
Step 2: Staff Training (2–3 Months)

Training staff is essential to ensure all team members understand their responsibilities in the research process. Key areas of training include:

  • Good Clinical Practice (GCP): Required for all individuals involved in clinical trials.
  • Protocol Training: Tailored to the specific studies that will be conducted if already identified. Training should include role play and dry runs for research naïve sites.
  • Patient Engagement: Instruction in techniques for successful recruitment and retention of trial participants.

Time Commitment:

  • Initial GCP training may take 1–2 days per staff member.
  • Ongoing protocol-specific training will be necessary as new studies are introduced.
Step 3: Infrastructure Setup (2–4 Months)

Setting up the necessary infrastructure for a research site is critical. This includes:

  1. Space Allocation: Designating areas for trial-related activities, consultations, monitoring visits, and sample storage etc.
  2. Equipment Procurement*: Depending on the nature of the trials, possible requirements include:
    • Freezers for sample preservation (at -20°C or -80°C).
    • Centrifuges for blood sample processing.
    • Secure storage solutions for trial documentation.
    • Computer for data entry.
  3. IT Systems: Deploying electronic data capture (EDC) systems while ensuring compliance with data protection regulations such as GDPR. It is recommended to implement a patient visit management system or scheduler.

*In most cases, the sponsor usually supplies the equipment needed for a trial, if it is requested by the research site.

Step 4: Regulatory Approvals and Contracts (1–3 Months)

Compliance with regulations is mandatory for any research site. This phase includes:

  • Obtaining Approvals: Registering with relevant ethics committees, the Health Research Authority (HRA), or other governing bodies.
  • Negotiating Contracts: Finalising agreements with trial sponsors or contract research organisations (CROs).
Step 5: Patient Recruitment and Trial Preparation (2–3 Months)

Once the site is approved, the focus shifts to recruiting participants and preparing for the trial. Key tasks include:

  • Screening Patient Records: Identifying eligible participants within the existing database.
  • Advertising: Promoting the trial through various channels, including flyers, social media, and community events.
  • Trial Setup: Organizing logistics such as appointment scheduling and sample shipping.

Time Commitment:

  • Recruitment campaigns may take 1–2 months per trial.
  • Trial setup will generally overlap with recruitment efforts.

Tips to Streamline the Process

1. Engage Experts: Collaborating with a consultancy, like Biopharmaal Consultancy, can optimise efficiency and ensure compliance.

2. Start Small: It may be beneficial to initiate with simpler trials before progressing to more complex studies.

By following these guidelines, GP practices can effectively transition into research sites, ultimately contributing to healthcare innovation and patient care.

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