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1. Are there special laws or regulations about conducting research that clinical trial investigators need to be aware of?
Yes, clinical research is highly regulated. A potential clinical trial investigator can begin to find more information on the website for the FDA's Center for Drug Evaluation and Research. Quintiles suggests starting with Federal Regulations for Clinical Investigators. 2. What benefits will I get from my participation?
There are several potential benefits of being a clinical trial investigator, which may include the advancement of medical science, providing access to different treatment options to your patients, being viewed as a thought leader within your community and by your peers, gaining familiarity with medications and therapies before they reach the market, establishing a new revenue stream, and/or professional development that helps meet your employer's expectations. 3. What is a Contract Research Organization (CRO)?
Sponsors (i.e., the pharmaceutical companies whose drugs are being tested) often partner with CROs such as Quintiles to manage their clinical trials. CROs provide operational management and support, which may include management of the investigative sites - recruiting them, helping sites complete administrative paperwork, and monitoring the sites throughout the trial. 4. My practice doesn't have an Institutional Review Board or Ethics Committee. Don't I need one in order to conduct a study?
Yes. If there is not an IRB/EC that oversees and approves research studies at your site, the sponsor or CRO will choose one for a specific study and will pay for all related costs charged by that central IRB/EC. You would receive detailed instructions from the sponsor or CRO if you were chosen to be a clinical trial investigator for a study. 5. What demands will there be on my time if I become a clinical trial investigator?
It is advisable that you spend time taking basic Good Clinical Practice (GCP) and informed consent best practices training. There are several providers of such training, such as the Association of Clinical Research Professionals (ACRP).Before a study begins, you will generally need to attend an investigator meeting, at which the investigators and study coordinators from each research site are trained on the protocol. These meetings generally last about two days, not counting travel time (travel expenses are paid by the sponsor), and often include a Saturday in the schedule. Each study is different, so you will likely spend some time reviewing and negotiating a study agreement and budget before the study starts, and comparing your actual costs to that budget throughout the study. 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 study coordinator will necessarily be spending time with the CRA during each visit. You also may occasionally be audited by a sponsor, CRO, or your country's regulatory agency. 6. Can the other physicians in my practice be involved in the same studies in which I participate?
Yes, they may participate as subinvestigators as long as it is acceptable to the sponsor/CRO and the appropriate regulatory documentation is submitted before their involvement begins. 7. Study Coordinators are expensive; could I just fill that role with one of my nurses?
Yes, though given the importance of this role, you must ensure he/she is qualified and has a reasonably balanced workload. 8. What are the qualifications of a study coordinator?
A study coordinator should have experience with clinical research - patient care, data reporting, paperwork, understanding of patient recruitment, etc. He/she should have good organizational and personal interaction skills. Ideally, he/she should be certified by an accrediting body. 9. What type of technology infrastructure do I need?
A fax machine is a must, as well as a computer with an Internet connection. High-speed Internet is preferable, as many studies require electronic submission of study data. You may be asked by some sponsors and CROs whether your electronic systems are compliant with the FDA's "electronic records and submissions" regulation. 10. Will Quintiles or the pharmaceutical company cover any costs for specialized equipment that I have to purchase for my site to use during the study?
Sponsors will generally purchase or lease such equipment for you for use during the study if it is uncommon for a research site to have it. If on the other hand most sites would typically have a certain type of equipment and yours does not, it's less likely the sponsor would provide it (meaning it's less likely you would be selected to participate). 11. How do I ensure that pharma companies and CROs know I want to be an investigator?
It depends on the structure of the company. Some have a centralized department that handles investigator identification, others have managers of individual studies do it. It is important that you find the right department or people within the companies with whom you want to work. It may also be helpful to post your site's profile on Centerwatch's website. To be considered for Quintiles studies, please email us at ISS.Referrals@quintiles.com. 12. How do I budget for a study?
You are generally paid more for procedures by research sponsors than by third party payors. However, there is work involved that is not directly tied to your research patient activity, so it is important to strike the right balance. Sponsors usually will have a predetermined amount that they are willing to pay per patient for each procedure or patient visit. To determine whether that per-patient amount will reasonably compensate you for your time, you should first project how many patients you feel you can enroll based on the study inclusion/exclusion criteria (it is best to be conservative, as very few sites enroll the number of patients they originally project), as well as how many patients you may have to screen to achieve that number (remember that not every patient you recruit will ultimately meet the protocol requirements for study entry). Consult the protocol to see what procedures are required at what point for each patient and assign a cost and assign your standard cost to each procedure, and apply the results to the number of patients you expect to enroll. You then must also consider how many hours of effort are necessary to run the study effectively (see the question above regarding time commitments), and assign an appropriate bill rate to each staff person who will be involved (including yourself). You must then consider any other costs such as overhead, storage fees, pharmacy fees, etc. You should also be sure that the cash flow is reasonable, as there are a lot of upfront costs to starting a trial. If you would like to participate in the study but believe the per-patient compensation being offered is insufficient for the time and costs involved, you may attempt to negotiate a different per-patient rate, and the sponsor of the study may or may not be willing to agree to the adjusted rate. Every study is different, and it is impossible to provide a comprehensive list of budget considerations here, but the above guidelines are important. If you work on a Quintiles study, a representative from our Site Startup Unit will be responsible for helping you and the study sponsor achieve a mutually agreeable budget. 13. 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. 14. If I am offered a study but decline to be an investigator, do I risk not being considered for future studies?
That's doubtful; no company wants you to take on a study you don't feel you can perform well on. In fact, most companies would welcome knowing the reason(s) why you aren't interested, as that may be very valuable feedback they can use in planning the study. 15. Do I need an attorney to review my study contracts?
Until you are comfortable with interpreting legal language, you may wish to have an attorney review your contracts to ensure you are not taking on any undue liability. If you opt for this legal review, it is advisable that you find an attorney familiar with clinical trials; otherwise he/she may not know what parts of the contract are truly important, which leads to time wasted with unnecessary negotiations and is not the best use of the money you're paying the attorney. 16. What is my liability if a subject is injured or feels they have not received a benefit?
During contract negotiations, you should request formal indemnification in writing from the sponsor if it is not offered. This will outline the conditions under which each party will be responsible for patient injury. In general, if you did not contribute to a patient's injury through your own negligence or willful actions – for example, if a patient has a bad reaction to a study drug and sues you – then if the sponsor has provided you with a formal indemnification, the sponsor will assume your liabilities and pay your defense costs, if any. If you do not get a formal indemnification, you will not be liable for injuries if you are not found to be at fault, but you generally will have to pay your own defense costs. 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 you make sure patients understand what they are signing and that you explain this to them. If a patient decides to take action against you regardless (which is very rare), the indemnification from the sponsor will protect you as described above. 17. Do I need special insurance to conduct studies?
Sponsors generally will not use doctors or institutions in a study unless the doctors and institutions have sufficient medical malpractice insurance to reasonably cover any damages that they may cause to patients if they are negligent or make medical mistakes. Sponsors' opinions as to the amount of insurance that is reasonably necessary to cover such damages varies from sponsor to sponsor and from study to study. The amount of insurance that the sponsor is requesting you to carry will be stated in the study agreement, and if you do not have the amount of insurance requested, some sponsors may agree to accept a lesser amount, but others may decide not to use you for the study. 18. Can I publish findings or results only from my set of patients?
Sponsors virtually always reserve the right to make the first publication of study results based on data from all patients at all sites. Once that publication occurs, you are generally able to publish your own conclusions provided the sponsor reviews your proposed publication to ensure that you are not disclosing trade secrets unrelated to the data your patients generated. The actual terms under which you are allowed to publish will be in your study contract and/or the study protocol, and should be consulted before you publish.