There are many reasons that clinical trials may be of interest to physicians:
- access to investigational therapies for their patients,
- expanding knowledge and understanding of conditions or disease processes and the therapies used to treat them,
- interest in publishing or participating in scientific advisory boards,
- financial diversity for their medical practice.
Whatever the motivation, there are several things to consider before launching a new clinical trial business.
Getting involved in clinical research can be challenging. Many new investigators struggle for years to get a clinical research business off the ground and then once they participate in their first study, it isn’t what they expected and they abandon clinical research altogether. It’s important to be aware of the requirements and challenges of being a clinical trial investigator before deciding to proceed.
Challenge 1: Financial
It costs money to launch a clinical trial business. How much money depends on several factors including existing infrastructure, facilities, staffing, equipment, and location. In order to get selected for a clinical trial, everything needs to be in place and then it could take months, even years to land the first study. Once selected for the study, it typically takes a few months before the study starts. Even after the first participants are enrolled, it will be several more months until payments start arriving.
Challenge 2: You need experience to get experience
Pharmaceutical sponsors are aware of the need to include new investigators in clinical trials, but most would rather that the investigator gets their initial experience with another sponsor. There is a lot at stake in clinical trials and most sponsors prefer to select investigators who have experience in clinical trials. Unless you’re connected, it will likely be difficult to get a sponsor to take a chance on you.
Challenge 3: Workload
Clinical trials are additional work for physicians who participate. When starting out, you likely won’t be able to carve out the appropriate time in your schedule for all the clinical trial activities and responsibilities. You will need to be able to add to your current workload. As your clinical research practice matures and the work becomes more consistent, your schedule can be modified to account for the new work created by the clinical trials.
Challenge 4: Risk
As the principal investigator in a clinical trial, you are responsible for everything that occurs at your site relating to your site’s conduct of the study and the study participant. While you will typically be indemnified for anything untoward that may occur with the investigational product, you will still need to ensure that you have appropriate insurance for the business and malpractice coverage for your clinical trial activities.
Financial risk comes from investing in facilities, equipment and staff and not having the income to cover those expenses. There are ways to mitigate those risks, but careful planning is required.
The next category of risk concerns the negotiation of the NDA (non-disclosure agreement), study contract and budget. Clinical trial contracts and NDAs are typically very one sided protecting the interests of the pharmaceutical company. Do you have an attorney experienced in the unique nuances of clinical trial contracts? Likely not. There are not many around and those that are, likely work for a pharmaceutical company or CRO.
Budgets add yet another layer of risk. The pharmaceutical company or CRO will provide a draft budget for your review and acceptance. How will you evaluate it to ensure that it is fair and will cover your expenses in the study? The payment terms must also be evaluated to ensure that your site is protected as much as possible from financial strain.
Challenge 5: Getting selected as a site for a study
How do you even start to get on the list as a potential site for a clinical trial? I’ve spent 28 years making contacts and getting my sites in databases that sponsors and CROs use to identify potential sites for a study. New sites don’t have the time, resources or connections in the early days. Even if you get a feasibility questionnaire for a study, how do you stand out when you’re competing against sites that have successfully completed hundreds of clinical trials? As a first step, register with any company that has an investigator registry.
Challenge 6: Space, Space and more Space
Clinical trials require a significant amount of space for storage. Although the transition is occurring to more electronic based documentation in clinical trials, the storage requirements are an important consideration. Space will be required to store: Study documentation and charts (if electronic documents and charts are not being used), lab supplies, lab shipping boxes, drug storage, and other study equipment and materials. Following completion of the study, study documents need to be stored for 15+ years. Exam rooms and workspace are needed for study coordinators to see participants and complete documentation.
Space is required for the study monitor when they come on site for meetings and to monitor the data.
Challenge 7: Cash flow and accounting
Payments for clinical trial work can be considerably delayed. It is not uncommon for there to be a delay of 3, 6, 12 months (or more) from the time a participant had a study visit to the site receiving funds from the sponsor or CRO. In addition, the site will need to develop a robust accounting system for tracking and reconciling payments for clinical trial visits and chasing down outstanding invoices. This can consume considerable time, effort and expertise.
Things to consider when deciding on participating in clinical research.
Time: Do you have additional time in your schedule for clinical research. Assume an additional few hours a week to start and then up to 10 hours a week once you get selected for your first clinical trial.
Facility: In order to pass a “Pre-Study Visit” (an evaluation visit), you will need to demonstrate you have the space for a clinical trial. The study Clinical Research Associate (CRA) will want to see your exam rooms where you will assess the participants; the space where they will work if they come on site for a monitoring visit; the locked, temperature monitored area where drug will be stored; the secure area for storage of study supplies; the area where blood samples will be packaged for shipment; the ability to plug in and charge a large number of devices used for clinical trials (tablets & ECG machines being the most common).
Equipment: Centrifuge for processing lab samples, min/max temperature monitoring devices for ambient drug storage, refrigerated storage, freezer storage (if required for the trial); computers for data entry (along with great internet access). Any equipment used in a clinical trial will need to be calibrated annually (or more frequently if required in the equipment manual).
Staff: Having a Sub-investigator is a must. The PI needs to have backup even if the sub-I is not active in the study. A Study coordinator is also required. You may be able to re-purpose someone from your own staff at the beginning, but you will need someone responsible for the majority of the work associated with the clinical trial.
Training: GCP training and training on clinical trial regulations (for all staff involved) are required before a sponsor will even consider a site for a study. However, this training is not sufficient to guide you through all the aspects of a clinical trial. It gives you the rules that you must follow, but additional training is necessary to ensure understanding of how to apply those rules in the real world of conducting clinical research. Training on shipment of hazardous materials is also required for anyone shipping lab samples.
Written procedures for clinical trials: Prior to selection for a study, the site will need written procedures in place to cover key aspects of a clinical trial. Some examples include Obtaining informed consent, Adverse events, drug dispensing etc. In addition, you’ll need written procedures documenting how your written procedures are created, how training occurs and the schedule for reviews of your written procedures.
Vendors: Accounts should be set up with couriers (primarily Fed Ex in North America), a x-ray facility, potentially – a dry ice supplier, and, depending on the study, a local lab. If other specialized tests or assessments are required for a study, agreements with other specialists or specialty testing facilities may be necessary (i.e. audiology, neurology, CT or MRI etc.). For any vendors that have patient contact or require transmission of study information, a confidentiality agreement and service provider agreement will be necessary.
Basic Site Start-up documentation:
- A Curriculum Vitae for Principal Investigator and all staff will need to be drafted and kept up to date.
- Copies of medical and nursing licenses
- Certificates of insurance for malpractice and commercial liability
- GCP certificates
- Dangerous goods training certificate
- Confidentiality agreements with your staff
- Written procedures
- Temperature monitoring log
- Calibration certificates and maintenance log for all equipment
Study Specific Considerations:
Everyone involved in a clinical trial at the site will complete study specific training. The training required will vary based on the individual role. The training can be anywhere from one hour to eight hours (or more) per person depending on the study requirements.
Next steps – so the basics are outlined. There are several options for investigators to get started.
Option 1: try to get everything in place yourself.
Option 2: find a mentor to help who’s experienced in clinical research.
Option 3: hire a consultant (or several consultants for different aspects of clinical trial site planning and execution).
Option 4: join a Clinical Trial Network that helps new sites get set up and offloads some of the work.
Option 5: become a sub-investigator or PI for an experienced clinical trial site.
This article just begins to scratch the surface of what’s required to be an investigator for clinical research studies. If you’d like to know more, please use the Contact link at the top of the page.
Whichever path you choose I hope you find clinical trials to be as rewarding as I have. Being part of a system that produces exciting new therapies and vaccines is incredible. The clinical research community is an amazing one with lots of fantastic, brilliant, hard-working people dedicated to serving the needs of patients.
Ted Trafford has worked at Probity Medical Research (PMR) for 28 years and now leads the business development team there. Ted is a speaker and consults for pharmaceutical companies and clinical trial tech companies. A significant portion of Ted’s time over the years was spent teaching investigators how to build successful clinical research practices. PMR is a large network of over 65 sites across the US, Canada, Australia, Chile and Mexico.
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