Pros: The Benefits to Your Practice

Taking part in clinical research can benefit your patients, your practice and you personally.

For Your Patients

Any patients of yours who participate in a clinical trial would get...

• New treatment options not generally available yet.
• More extensive supervision and oversight.
• Detailed testing and labs – for free – they wouldn't get otherwise.

It's also possible that undiagnosed issues might be identified. This is rare, but it sometimes happens through the extensive testing.

For Your Practice

Participating in clinical research would also benefit your practice by:

• Broadening what your practice has to offer.
• Diversifying your practice's finances.

Running a clinical research program would provide a revenue stream in addition to, and completely independent of, your traditional patient care. You'll be paid directly – and reliably – by the pharmaceutical company running the research program. No submitting claims to insurance or trying to collect deductibles from patients!

For You Personally

What drew you to the field of medicine? A desire to help people, of course. But probably also a love of science. Doing clinical research would give you the opportunity to:

• Get involved with new, cutting-edge developments in allergy, asthma and immunology.
• Challenge your intellectual curiosity by participating in clinical experimentation.

 What Do You Need to Get Started?

To get started with clinical research, you'll need to carefully consider these four areas:

• Staffing and Training

  One common mistake to avoid is having your allergy practice staff do double duty as your clinical research staff. Instead, you want to keep these two sides of your business separate. This is the only way things will run smoothly and successfully. So, once you commit to a clinical research program, plan on hiring a dedicated clinical trial staff.

  The first person you'll want to hire is a clinical research coordinator (CRC). This person, in conjunction with the PI, handles some or all of the following responsibilities:

  • Meeting regulatory requirements
  • Addressing the concerns of institutional review boards (IRBs)*
  • Recruiting patients
  • Following up with patients
  • Gathering and tracking data
  • Collecting specimens
  • Managing, monitoring and documenting clinical visits
  • Handling the budget and contracts for the research program
  • Billing the contract research organization (CRO)

  (*An institutional review board, or IRB, is an independent ethics committee or ethical review board that approves, monitors and reviews biomedical and behavioral human research to protect patients' rights and safety. IRBs can approve or decline research, require modifications to study protocols and stipulate changes in marketing efforts for patient recruitment.)

  That's a lot of responsibility, isn't it? You'll want someone who is highly organized, pays meticulous attention to detail and enjoys working with and collecting data.

  Ideally, you'd be wise to hire an experienced CRC with a clinical research certification. Such a person could handle up to five or six studies, depending on the study size and enrollment criteria.

  If you'd rather promote and train someone from within your practice, be aware of the time investment involved. You'll need to allow ample time for training them, as well as time for them to truly learn the new role and responsibilities.

  Consider using a medical technologist, laboratory technologist or surgical technologist as your CRC. They're already used to following regulations and protocols and to staying compliant with the Clinical Laboratory Improvement Amendments (CLIA). They can typically draw labs, process specimens and keep appropriate documentation. And they're much less expensive than an RN!

  If you'd like to research the hiring and competency assessment guidelines for CRCs that the Association of Clinical Research Professionals has put together, please see the section Additional Resources at the end of this module.

• Equipment and Space

  Each clinical trial will have its own specific equipment and space requirements. However, there are some general items you need to have available:

  Dedicated research exam room

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  This needs to be an attractive space to examine/study patients in, as well as be clean and organized to impress sponsors.

  Refrigerator, freezer and shelving

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  You'll need these to store products.

  Backup electricity

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  You'll need a generator or alternative backup plan to preserve product if you lose electricity.

  Storage space (physical and virtual)

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  You'll need physical storage space with file cabinets and virtual storage space for all your research records. Federal regulations require you to retain research records for at least three years after the research has been completed.

  Office space for CRC

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  The CRC needs an office or workspace with a computer, internet access, and dedicated phone and fax lines.

• Budgeting and Billing Compliance

  Careful budgeting is essential for the success of your research program! If you don't correctly identify all program expenses up front – and make sure they're covered – you risk losing money. To ensure the profitability of the research program, be sure to carefully review the study requirements and identify both fixed and variable costs:

  Fixed Costs	Variable Costs
  Your CRC's salary Facility fees: % of rent % of utilities % of IT Storage costs Other overhead costs	Lab fees Supplies Equipment

  Finally, be sure to include reimbursement for the work relative value units (wRVUs) associated with each patient's type of visit. For an initial screening, this is typically a level 3 or 4 visit. For follow-up, this will most likely be an established patient level 2 or 3 visit. And don't forget to include treatment for adverse events like anaphylaxis.

  Negotiating a favorable contract with the sponsor is key to recouping your costs. Ask for reimbursement for everything:

  • Storage costs – documents are required to be stored for three years after a drug is approved and marketed
  • Pharmacy fees
  • Labs
  • Supplies (if they're not provided)
  • Dry ice

  You can even ask to be reimbursed for a percentage of overhead.

  If a study requires any additional items not covered in the contract, be sure to ask for reimbursement for those too.

  Okay, that takes care of budgeting. Now let's see what proper billing compliance entails.

  First of all, keep your research billing and your allergy practice billing absolutely separate! Research costs must be billed to the research study – not to patients or insurers. On the flip side, be careful not to accidentally bill your regular patient care to the research program.

  Second, to keep everything separate and ensure proper billing for each, be extra careful with your documentation. Meticulously identify and document all services you provide to patients in the research program. Take pains to separately document any regular clinical care you provide to your patients.

• Data Management

  

  When you run a clinical trial, you'll be swimming in data! To keep from drowning in it, you'll need a solid, supportive infrastructure. You'll be collecting paper and/or electronic data from your research patients, and this data needs to:

  • Be of the highest quality
  • Be submitted according to strict timelines
  • Comply with federal, state, local and industry guidelines

  Large research programs often invest in a Clinical Trials Management System (CTMS). This software provides the ability to measure productivity, keep track of finances, schedule patient visits and pay patient stipends. If you're just starting a clinical research program, though, you probably won't need this. And small practices may not need it at all.

  Operate as if you will be audited! Document meticulously and be sure you're meeting all regulatory requirements.

 Types of Research Studies

What kinds of research studies can you get involved in?

The most common types for private practice are industry-sponsored studies. The pharma sales representatives who visit your clinic can put you in touch with their medical science liaison (MSL). MSLs can provide information about current and future clinical trials being run by their company.

Here's what you can expect when you work with the pharmaceutical industry:

• Pharma companies are good at training physicians and their staff as well as providing oversight.
• They develop study protocols and get them approved by the institutional review board (IRB).
• In these studies, the PI doesn't own the data and can't publish studies about the research. Only the pharmaceutical company can do these things.

Other types of studies – less common for private practice but still possible – include clinical studies run by the National Institutes of Health (NIH). These are publicly, rather than privately, supported studies typically done at academic institutions.

You'll also see investigator-sponsored studies, where the clinic or allergy practice is both the sponsor and the investigator. In these types of studies, the PI owns the research and can publish reports.

Finally, some studies are run by nonprofit foundations, such as the American Lung Association or the Asthma and Allergy Foundation of America (AAFA).