The Top Frequently Asked Questions and Answers for Physicians:
Who can become a clinical trial investigator?
The majority of clinical trial investigators are physicians in private practice. You do not need to be associated with a medical school or teaching hospital to qualify as a clinical investigator. No previous experience as an investigator is needed to qualify.
Why should I consider becoming a clinical trial investigator?
Clinical investigators play an important role in the development of drugs, therapies and medical devices to combat disease, treat chronic and degenerative diseases, and improve the health of people throughout the world. There is a need for physicians in private practice to join as investigators in these trials. By conducting clinical trials, physicians:
Remain at the cutting edge of your specific area of therapeutic interest
Gain recognition as a thought-leader within your professional community
Open opportunities for additional revenue for your practice
Offer your patients new treatments that may only be available through participation in clinical trials
Support the evolution of medicine
How will I become part of Exemplar Research's research organization?
We first consider your therapeutic specialty to confirm that it meets our needs, based on the types of studies that are most prevalent right now, along with information around the size of your patient population. If the above is a good fit, and you have the desire to move forward, we provide the clinical, administrative, regulatory and marketing services to be successful. We don't require a long-term commitment and you decide on a study-by-study basis as to which study best fits your needs.
What research services does Exemplar Research provide?
- Access to studies
- Complete research team
- Management of all FDA regulatory documentation and reporting
- Advertising / patient recruitment
- Scheduling / screening
- Administer study drug and conduct study based on protocol specifics
How do I know if clinical trial investigation is right for me?
The most important factor is that you have a thorough understanding of the commitment needed to participate in a clinical trial. Many investigators find participation a very rewarding experience.
Exemplar Research, in coordination with with you, always asks these questions about specific trials:
Does this trial fit my patient population?
Is there an adequate patient population to meet enrollment goals?
What are the potential pitfalls of this protocol?
Am I, along with my staff, committed to all that will be involved in this trial?
How do I incorporate clinical trials into my practice?
Clinical trials require a fair amount of management and documentation. That is where Exemplar Research becomes your partner in handling the day-to-day process of conducting the study.
What liability do I have if I participate in a clinical trial?
Generally, you have indemnification against actions stemming from a clinical trial as long as you strictly adhere to the protocol, the clinical trial agreement, and exercise reasonable medical judgment. You should be prepared to provide proof of malpractice insurance to the sponsor or the sponsor's representative; however, your participation in a clinical trial usually will not impact your premiums.
Each patient will have signed an informed consent form that describes possible risks and possible benefits of taking part in the study, including that the patient may not see any improvement in his/her condition. It is important that we make sure patients understand what they are signing and that we explain this to them.
Exemplar Research also carries the required professional liability insurance from one of the top pharmaceutical industry insurance carriers.
What is the Federal oversight to ensure patient safety?
All aspects of clinical research studies are closely monitored by the federal and state governments, as well as the organizations that fund the studies. But when it comes to watching out for study volunteers, there's one more layer of protection: the Institutional Review Board, or IRB.
The IRB is a group of doctors, research experts, and community members whose only job is to protect the rights and well-being of study volunteers. Every institution or organization that conducts clinical research must first have the study approved by an independent IRB before they can begin.
IRBs ensure that studies are conducted ethically by, one, approving them before they start and, two, periodically checking in on the study while it is being done.
Every clinical research study done in the United States must get a seal of approval from an IRB before a single volunteer is enrolled. The IRB also serves as a resource for study volunteers, who can contact the IRB directly at any time if they have concerns about their rights as a research volunteer.
What happens when I am selected to be a clinical trial investigator?
We have seen over the last two years that studies have become more competitive, which is why our team at Exemplar Research works very hard to get our research sites considered for studies that make sense.
If you/we are selected for a specific study, you will need to review other forms, including confidentiality agreements, study protocol and an investigator drug brochure (IDB) describing what is known about the drug. Later, your office will be visited by a clinical research associate (CRA) to assess your commitment and your site's suitability for the trial. We will coordinate all of the communications, paperwork, scheduling and will host this first visit. Our team is always there with you, including our President, Study Manager, and Coordinator(s).
What are the general responsibilities of a clinical trial investigator?
An investigator ensures that a study is conducted according to the:
Signed investigator statement
An investigator/Exemplar Research must obtain the informed consent of each study participant to whom the drug is administered.
Can the other physicians in my practice be involved in the same studies in which I participate?
Yes, they may participate as sub-investigators as long as it is acceptable to the sponsor/CRO and the appropriate regulatory documentation is submitted before their involvement begins.
What demands will there be on my time if I become a clinical trial investigator?
Before a study begins, you may need to attend an investigator meeting (all expenses paid by the Sponsor), at which the investigators and study coordinators from each research site are trained on the protocol. In many cases as an option, the Sponsor representative will provide this training on site.
During the study your site will be visited by representatives of the sponsor or CRO who review documentation (such as subject records/charts) to ascertain whether the study is being conducted properly. These representatives are called monitors or Clinical Research Associates (CRAs). You will be meeting with the CRAs during many of these visits, spending from a few minutes to perhaps longer depending on the CRA's findings and questions. Your Exemplar study coordinator will necessarily be spending time with the CRA during each visit.
Typically, the average weekly time spent is .5-1 hours per study, or 5-10% of the overall study activities regardless of the length of the study. The bulk of your time will be the initial required training for the study (most done online) and then the initial patient physical. We then take it from there.
What kind of reports does a clinical investigator provide?
Progress reports: We furnish all reports on behalf of your site to the drug's sponsor or the sponsor's representative; the results are collected, evaluated and submitted to regulatory agencies
Safety reports: We promptly report to the sponsor or the sponsor's representative any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator must report the adverse effect immediately
Final report: We provide to the sponsor or the sponsor's representative with an adequate report shortly after completion of the investigator's participation in the study
What is the typical compensation per study?
Enrolled patient revenue to the investigator ranges from $200 to $5,000 per patient depending on the study type and duration. We provide a detailed Revenue Sharing Document with each PI before we get started so that you are fully aware of the percentage that is allocated to you, based on the number enrolled and value of each patient. Unlike many Site Management Organizations around the country that will assign a set dollar amount per patient, we provide full transparency and provide a percentage sharing plan so that any amount that is collected based on the enrollment process is shared. We also share the complete study budget with you, again, unlike most of the SMOs around the country. Our sites receive payment once Exemplar Research receives payment from the Sponsors, typically quarterly.
Am I allowed to bill a patient's insurance company for the work I do while the patient is on the study?
Beware of insurance fraud, even if unintentional. Your study budget will include payments for procedures and effort that are outside the standard of care; you therefore may not bill third party payors (whether private insurance companies or government organizations such as Medicare) for such costs. Occasionally a sponsor may pay for certain standard of care items – you may not bill third party payors for these costs either. You also may not bill any third party payor for any drugs, devices or medical products supplied to you as part of the study.
What is an institutional review board (IRB)?
In the United States, an institutional review board (IRB)) is a group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of participants.
For more information, please visit: "Understanding Clinical Trials" on the ClinicalTrials.gov website