In short, the answer is “Yes, anything is possible,” however, it may require a lot of effort and creativity on the part of the physician and his support staff. The first option is to be added as a sub-investigator to as many studies as possible. After that point, the original PI of the study can call the Sponsor/CRO and request a PI change. Another option would be to do the first half of option one, and then when a new study becomes available, apply as the PI for that study and check “Yes” on the box where they will ask you if you have clinical research experience. In either case, it is possible, but the bottom line is that you constantly need new studies to give yourself the greatest chance for success. You can purchase my DVD on how to get more studies for your research clinic just like the viewer who asked this question did. As always, add your comments below on any techniques you have had experience with for this topic.
Can A Doctor With Little Research Experience Ever Become A Principal Investigator Of A Clinical Trial?
In response to a question I received from a brand new study coordinator the other day, I discuss free software that are available for a study coordinator, or even an entire research team, to keep their studies operating smoothly and efficiently with everyone on the same page. I also get into the reasoning behind why it is important to keep track of your information such as patient names, source docs, visit dates, contact information, etc when conducting even one clinical trial. I am curious to hear from you guys in the comments below as to how you go about keeping your studies organized.
What’s the difference between Nurse Practitioners (NPs) and Physician’s Assistants (PAs)? Is it only the letters after their names on the nameplates on the office door? Does one wear a white coat or koi scrubs and not the other? Most people don’t know the difference and it may not really matter. Both are highly trained medical professionals who can perform a wide variety of functions to help you maintain your health.
Nurse practitioners are first registered nurses (RNs). This involves three to four years of college level training at a certified school. Gaining level of Nurse Practitioner requires further training at the master’s and possibly even the doctorate levels. NPs choose a specialty during training such as pediatrics, occupational health or oncology. The Nurses model of practice focuses on maintaining health, the preventions of illness and patient education.
Physician’s Assistants also have training beyond the four years of college. The additional education is largely clinical in nature relating to diagnosing and treating disease, which is the physician’s model of practice. PAs don’t specialize at this level. Instead they pass through a rotation of specialties much like that of a physician and a master’s degree is earned.
NPs and PAs are licensed through different organizations which set the standards for competency in their fields and administer tests and certifications. NPs must first become certified on the national level as RNs, then take additional tests for licensing as a NP on the national and state level. PAs, when finished with their program of study, must take a national exam and become licensed in their state to practice. Both must meet required continuing education standards and become recertified at regular intervals.
NPs can do everything a nurse can as well as some things a doctor can. They can diagnose and treat common illnesses, order diagnostics tests and write prescriptions for many drugs. They coordinate referrals to specialists and can perform certain procedures and minor surgeries. In some states nurse practitioners can open their own offices and work for themselves without supervision but in cooperation with doctors and other health care providers. Many doctors’ offices employ NPs to carry out routine office visits with patients. Other NPs work in hospitals and clinics focusing on the specialty they chose during training.
Physician Assistants always have to work under the supervision of a physician, although they can do many of the same things. This might be the biggest difference between NPs and PAs. However, they can assist during major surgeries. The physician they work under may give them some in-office supervisory responsibility over medical assistants and technicians and other autonomy based on the competency of the PA. Most work in the office of the supervising doctor although some may work in clinics, nursing homes, hospitals, etc., but still accountable to the doctor he or she works for.
Medicare and Medicaid recognize both as providers and most insurance reimburse for services at favorable rates.
The differences between Nurse Practitioners and Physician Assistants (video link) aren’t very noticeable to patients. Both work closely with other members of the medical community to provide the best possible patient care. But you might notice a difference on your bill if you see an NP or PA instead of a doctor. And that’s not a bad thing.
Some of you may know that the Principal Investigator (PI) of any clinical trial, is responsible for the entire conduct of the study at the research clinic where the study is being conducted under their supervision. In fact, by signing the FDA 1572 Form, the PI is essentially making a promise to the FDA to conduct the study ethically and by following all Good Clinical Practice guidelines. Many private research clinics are owned by the PI or PI’s that conduct their studies at their own facilities, but many other private research clinics are not owned by PI’s. A good viewer question I received last week came from someone who owns a research clinic and is trying to find a good and fair way to compensate his PI for the studies that he is conducting. In this video, I discuss three payment options (although more certainly exist if you can get creative) that are common for research clinics in these situations. Check out the video and let me know what you think is a fair and reasonable compensation for PI’s.
The question I received from a clinical research manager recently was when to invoice for a particular cost associated with running a clinical research study at a site, the pharmacy fee. The individual asking the question wasn’t quite sure when to invoice this and also wanted to know if there were any other fees that she should invoice for that are commonly associated with invoice-able fees for clinical trials. In this video, I try to summarize when to invoice for certain clinical trial costs and also how to go about doing this. Please comment below with any other suggestions.
This video response to a viewer question earlier this week revolves around the topic of research study coordinators, their salaries, and how much is appropriate for a raise in a coordinator’s salary given a few specifications that I discussed in this video. Basically, this person has been a coordinator for several years, but has been with this particular company for one year and has not received a raise as of yet. If any of you have any advice for this viewer, just leave your comments below and let us know what an appropriate salary raise would be.