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What is your practice’s motive for getting involved with clinical trials—the extra revenue, the ability to offer novel treatments, an enthusiasm for research? Whatever the reason, you will need to make a significant commitment of both time and resources. Unfortunately, many practices find that they are underprepared or ill-suited for study participation, resulting in a frustrating experience for the practice and study sponsor alike. In fact, approximately 40 percent of first-time investigators never take part in a second clinical trial. And even if you want to participate in a second study, a pharmaceutical company may not be willing to work with you again if you do not perform up to their requirements the first time around—a policy referred to as “one and done.” After all, your mistakes could cost that company millions of dollars.
Should You Take Part in a Study?
There are some factors to consider.
Recognize your limitations. “The first and probably most important issue to consider before getting involved in a particular study is to determine whether or not you are the right fit,” said Elise Levine, CRC, OCS, who has completed more than 20 studies during the last four-and-a-half years at North Valley Eye in Mission Hills, Calif., where she is the administrator and the director of clinical research. “Review study information and do not select a study at random just because you want to participate. For example, if you do not see many uveitis patients and a sponsor is recruiting for a uveitis study, you are better off waiting for a more suitable match for your practice. Don’t sign up for trials that involve patient groups that you do not normally treat on a regular basis. It is very important to focus on your strengths and avoid studies that your practice is not equipped to handle.”
The principal investigator (PI) must be involved and provide oversight. The PI is the physician in charge of the research study and is ultimately responsible for its success or failure. Until the recent publication of an FDA document that outlines a PI’s responsibilities, 1 the precise role of the PI had been undefined.
Key staff must be able to invest plenty of time. Kristen Andrews, CCRC, clinical research manager at Wheaton Eye Clinic, in Wheaton, Ill., described some compulsory time obligations related to research participation. “Once accepted into a study, you should attend an investigator’s meeting, which is usually off-site, and plan to meet with study monitors when they visit your practice. Spend enough time to learn everything you can about the protocol so you can delegate study duties appropriately. However, while many tasks can be delegated, at our practice I require that an investigator physician meet with every patient during the informed consent process to answer medical questions and to explain the study’s risks and benefits.”
The research coordinator should be detail-oriented and meticulous. “A coordinator has to like conforming to a predetermined recipe. The protocol is a literal step-by-step outline of the visits that you must follow,” said Ms. Andrews. “It is helpful if the coordinator has a marketing-type personality for selling your site to a pharmaceutical company, inviting patients to participate in a study, and encouraging your staff to follow the protocol.” Likewise, Ms. Levine continued, “good communication skills are important—getting in touch with your monitor when there is a problem, and asking questions, for example.”
Sponsors look for low staff-turnover. “When screening sites for participation eligibility, pharmaceutical companies tend to look for practices with a low rate of staff turnover. In addition to the tangible and intangible benefits of fewer training sessions, staff members with longevity tend to have a better understanding of your patients and practice,” said Ms. Levine.
What about training? The pharmaceutical company sponsoring a study will train the PI and coordinators, who in turn, should train the remaining office staff who will be involved in collecting data for the study.
Do You Have the Right Patients?
Study enrollment is competitive between sites. Suppose the PI at your practice agrees to enroll 30 patients. If not enough patients are rapidly enrolled, then other sites may be allowed to increase enrollment and take over the patients that your practice was contracted to enroll. “This means that a practice must have an early, and comprehensive, understanding of the study. You should know what kind of patients you are looking for and either 1) have compiled a database of eligible patients or 2) know your patients well enough to be able to review your patient list and compile a database quickly. If you are advertising for patients, advertise soon after acceptance and be ready to receive patients for participation,” said Ms. Levine. Approximately 30 percent of the sites on any given protocol enroll 70 percent of the subjects for that protocol.
Don’t rush patient selection. “You can enroll patients too hastily. For example, a site may end up with a high screen-failure rate if the patients were not selected carefully enough to be good candidates for the study,” said Ms. Andrews. Do not enroll patients just to meet your recruitment quota. Selecting appropriate patients can define the success of your study. It is imperative to select those who will remain motivated and complete the study. “You want people who are engaged in participating and will show up for all their appointments, take their medication as directed, and complete the necessary paperwork,” said Ms. Levine. “Choose patients who pay attention to the details—those who can tell you at precisely what time of day they take their medication or use their eyedrops; those who are dutiful about their postop follow-up care.”
What motivates patients to take part? “Patients should never be allowed to participate in a study solely based on financial incentives. In our case, many of our patients are lower income and are motivated to participate because they receive free medication. However, it may be a sign of trouble when someone only cares about collecting money from a study,” Ms. Levine said.
Take time to ensure patients understand what’s involved. Confirming that a patient is suitable for a study and truly understands what he or she is consenting to is extremely time-consuming. “I do not want anyone in a study who does not understand exactly what is happening at every visit and what medications they might be receiving. This might take multiple conversations with a patient over a period of weeks—going back and forth answering questions, giving them time to take home their informed consent documents to discuss the trial with their family, and explaining the procedures. Ultimately, most people participate because they feel comfortable with the process,” said Ms. Andrews.
Do You Have the Space?
Space is an important consideration before becoming involved in clinical research. A practice must have ample room for the research staff to work with study materials, said Ms. Levine. “If your tech is using a little counter in an exam room when it happens to be empty, your site’s documentation for the study will suffer. The best scenario is a private office without distractions.” Study monitors also need a place with Internet access and a telephone where they can work and review your data when they visit, which can be as frequent as once per week during study enrollment. “You want to make their time at your practice as comfortable as possible because a positive relationship with your monitor goes a long way,” she added.
You also may need to open up extra lanes in order to see regular patients and study patients at the same time. And, a locked room for storing data and study medication is mandatory.
What About Your Documentation?
Pharmaceutical companies want to work with practices that maintain meticulous study records. While study data are similar to the data you would normally gather about a patient, it typically involves information beyond what is done during a routine visit. According to Ms. Andrews, “everything should be documented—including the time you performed a task and exactly how it occurred. You must be able to prove what you did, even five years from now, if the FDA audits you.”
Companies also look for practices that submit the required forms and data in a timely manner. For example, Ms. Levine guarantees that she will return study documents in 72 hours or less, which is an excellent way to demonstrate a practice’s motivation to participate. In turn, it improves the possibility that the study sponsor will be willing to work with you again—a goal that most practices involved in clinical research embrace.
1 For the FDA document on PIs, go to www.fda.gov and click through these links: 1) “Clinical Trials,” 2) “Guidance Documents (Including Information Sheets) and Notices,” 3) “Selected FDA GCP/Clinical Trial Guidance Documents” and scroll to 4) “Investigator Responsibilities—Protecting the Rights, Safety and Welfare of Study Subjects, Guidance for Industry.”
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