Be a Principal Investigator for a Clinical Trials Site at your practice

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• You can work with a sponsor (such as a drug or device manufacturer) to conduct a trial as a Principal Investigator (PI).  The clinical trial sponsor can be an individual, institution, government agency, or other organization that bears the overall responsibility for creating, managing, and financing the clinical trial.  As the PI, you head up operations at your research site.

  • PI responsibilities: 

    • Personally conduct and supervise the research

    • Ensuring that study personnel and other participating physicians are qualified with the right education, experience, and training to perform the study

    • Ensure that the clinical research participants are protected and that the research methodologies are in compliance with all local, state, and federal regulatory policies

    • Oversee the IRB approval and compliance process within your setting, and ensure the integrity of the data collection and analysis.  

    • Developing budgets

    • Managing audits and inspections

  • As such, becoming a PI is an involved process that must be undertaken in a safe and ethical way.  Many PIs take introductory courses on the principles and practice of clinical research.  Your sponsoring organization or company will often aid you through the logistics, but you can learn more from different workshops, webinars, conferences, publications, or other guides.  

    • Clinicians and their staff often undergo good clinical practices (GCPs) training, as it is an essential component of conducting clinical research. 

    • You can also become certified through CITI or another reputable resource. Studying the Code of Federal Regulations (CFR) or other documents relevant to the International Council for Harmonization (ICH) will help you learn and understand the requirements of clinical research and trials. This will also help you understand the forms that you’ll be needing in order to initiate a trial. 

  • Some of the things you will need to have in place:

    • Contracts

    • Recruiting strategies

    • Forms

    • Protocols

    • Regulatory documents

  • If you elect to treat this as a line of business, you need proper infrastructure,  including operations, finances, staff resources, technology, regulations, and training. You will need to understand the patient recruitment and enrollment process and you should also be aware of the differences between government and private payer policies.

  • You will also need to ensure you equip the practice with the infrastructure it needs to conduct clinical research.  It will add additional workload, so developing standard operating procedures (SOPs) that enable efficiency in conducting clinical research will be necessary to help ensure that the research is conducted in a consistent and timely manner, and that it doesn’t get in the way of clinical operations.   

    • If you have a sponsor, they will likely inspect the study site before it is approved and once again immediately after the study starts, to ensure the practice is well equipped and prepared to execute the trial effectively and efficiently. 

    • Some changes may include:

      • A secured room with a locking door, set aside specifically for the investigational product.  At the very least, you will likely need to keep the practice’s normal drugs separate from the clinical trial drugs.

      • Some products may need a refrigerator, freezer, or additional shelving for storage 

      • Any equipment that is being used has been serviced according to the manufacturer’s requirements

      • Safe space/technology for storage of research data and study supplies

  • You might want to hire an experienced study coordinator and other research members to handle paperwork, patient questions, and other logistics.  The goal for you should be to focus on looking after patient care and the medical aspects of a study while your staff coordinates the rest. The study coordinator can also be a trusted employee from your practice that knows SOPs well, but is looking for a change in responsibilities or a change in career.   As you add more trials, you will want more staff, as they help with several aspects essential to the success of your business:

    • Coordination

    • Recruitment

    • Follow-up

    • Documentation

  • You may also want to partner with a research site network, which can help you reduce overhead costs as technology, systems and training, as these can be divided across multiple sites. A site network may also offer collaborations on business strategies, marketing and patient recruitment campaigns. They can also share study lead opportunities and other strategies, as well as help you stay up to date on best practices and developments in the field. Networking with others doing clinical research is also beneficial for this reason.  

  • There are many clinical research companies that can help you to become a principal investigator at your site, and they may even provide the staffing you need (you will usually need some extra staff members to help with paperwork, patient questions, and other logistics).  While it can take some time to set up, once you are up and running, this can be great for both your patients and your practice!