(PDF 156 KB—Includes ONLINE EXTRA: A Glossary of Terms)
The climate of clinical research has changed tremendously in the last 10 years. Long gone are the days when the threshold for trial entry was low and the compensation for participation was high. Today, clinical trial involvement is heavily regulated and requires considerable tenacity and finesse from its participants. Maneuvering through the complex system of rules, expectations and negotiations is time-consuming and complicated.
Despite these changes, clinical studies may still be a good fit for your practice—see last month’s EyeNet for help in making that decision. If you have decided you want to get involved in research, how do you get started?
In the past, pharmaceutical sales representatives usually facilitated a site’s participation in clinical research. Interested physicians simply asked their rep to set them up with the right person within the company. These days, however, getting onto a trial can take a lot more legwork and perseverance.
Take care when talking to your sales rep. Changes in policy have created a “strict separation between sales and research at many companies,” said Kristen Andrews, CCRC. “And at those companies, it can actually impede your chances of participation if you attempt to go through the sales department for trial entry. At other companies, however, it is acceptable to ask your sales rep if they know of the right person to contact. Although they cannot make the contact on your behalf, they can help you find the correct person.” Ms. Andrews is the clinical research manager at Wheaton Eye Clinic in Wheaton, Ill.
Visit the NIH registry of trials at wwww.clinicaltrials.gov. Every clinical trial must register with the National Institutes of Health, and a list of trials in progress is posted on its trials website, which is sortable by condition, drug intervention, sponsor and location. “It will tell you which trials are currently enrolling, or not yet enrolling or closed. Usually, however, by the time a trial is listed here, it has already been filled with investigators. And even though a trial is open, you might not have access to it—it may, for instance, be a single-site trial or overseas. You have to nuance how you use the site,” said Elise Levine, MA, CRC, OCS, administrator and director of clinical research at North Valley Eye in Mission Hills, Calif. And although a trial may have its full quota of investigators, it still might be worth making inquiries, said Ms. Andrews. “Sometimes one of the originally selected sites experiences problems with enrollment, which may give us an opportunity to join the study. I review the list occasionally and call or e-mail some of the sponsors that are conducting studies suited to our capabilities and offer our practice in case they need a rescue site.”
Check the R&D section on pharmaceutical companies’ websites. Almost every pharmaceutical company has a research and development page on its website. Here you will find the areas of study the company is engaged in, as well as other research-related information. “On the website is an investigator interest form. Fill it out,” said Ms. Levine. “Once you submit this initial query, someone from R&D will contact you and send you an investigator profile questionnaire. They want to know why you think you have the means to do clinical research for them—what type of equipment you have, how many doctors will participate and whether or not you have a large enough staff available to assist in data collection, for example. Once you complete this background information, you are entered into the company’s database for future consideration.”
Get in touch with the medical-science liaison. Most pharmaceutical companies have a medical-science liaison—a person who gives physicians drug information and apprises them of new findings. People in this position can, for instance, discuss the off-label use of drugs, whereas sales reps cannot, said Ms. Andrews. “They are also very well tied into phase 4 studies and can help you get into the clinical trials database and make some contacts within the clinical research department for you.”
Keep up with the latest research. Read scientific literature, trade publications and industry newsletters. These are excellent places to find information about drugs in development and those that were recently approved. You also should contact companies engaged in research that is in line with your practice’s proficiencies.
Use personal contacts. “Any connections that you have at a pharmaceutical company will definitely be helpful,” said Ms. Andrews. “I set up my e-mail program to remind me to contact various sponsors once every three months if I have not heard from them. It is just another way to keep our site in the forefront of their minds and remind them that we are interested in participation. It is also an opportunity to provide any additional information about our site. You can also ask for recommendations from colleagues who are not competing for studies with your practice—in terms of their subspecialty or geographical location—and who therefore won’t be trying to get into the same studies.”
Assemble a Trained Staff
“It is usually very difficult to get chosen for your first clinical trial, particularly if you do not have experienced staff members. Pharmaceutical companies are looking for sites that are willing to take the extra step and hire a coordinator who will oversee the research activities,” said Ms. Andrews. Ms. Levine agreed and added, “Equally important, the principal investigator (PI) and research coordinator should be versed in the ABCs of clinical research, including good clinical practices and regulatory documentation, for example.”
Seek additional training. Individuals interested in supplemental training can pursue online and in-person clinical research courses and certifications. There are two industry-related organizations that offer a variety of professional development services, including online webinars, classroom courses, conferences and certifications for both physician investigators and staff members: The Association of Clinical Research Professionals (www.acrpnet.org) and The Society of Clinical Research Associates (www.socra.org).
Negotiate a Budget
Calculate your expenses. Budgets vary by sponsor, type of study and phase of study. Much of the time, budgets are negotiable in some way, but not to the same extent as they used to be. “While there once was a lot of wiggle room with budget negotiation, that is just no longer the case,” said Ms. Levine. “You really have to ensure that the monies the pharmaceutical company is offering you are going to compensate you for the work you are required to complete. You will receive a spreadsheet in which a dollar value is assigned to every item associated with the study. Review the calculations and determine if it is a realistic proposition for your practice.”
For some trials, said Ms. Andrews, “it can take eight to 10 hours or more to enter each patient’s information into the database. And, there are many small tasks that can add up to a lot of time for your site coordinator and staff. You really need an experienced person who can break down a budget line-by-line and determine the time it will take for those individual tasks. How long, for example, will it take to complete a patient visit, to process the data, to consent a person, and so on. You also need to account for hidden costs, such as document storage once the study is complete or payments for the patient’s parking. It is easy to lose money if you are not paying close attention.”
It is OK to take less. Sometimes a doctor may want to participate in a certain study because the treatment drug is novel or cutting edge. In these cases, it might be okay to agree to a lower budget.
“From my practice’s perspective, we are still establishing ourselves as a site that performs successfully, so we are willing to forgo extensive negotiations. Rather, our primary concern is often submitting the paperwork in a timely manner. The longer it takes to negotiate the budget, the more time that other sites have to say ‘We will do it,’ leaving us out of the loop,” said Ms. Levine.
Hit the Ground Running
If you don’t meet the sponsor’s requirements with your first clinical trial, the company might not want to work with you again. Increase your odds of participation in subsequent studies by following these do’s and don’ts:
- Do take clinical research seriously —do not think of it as just another project in the office.
- Do submit your data on time.
- Do have a doctor available to sign off on the piles of patient paperwork.
- Do not enroll patients who really do not qualify for the study.
- Do enroll enough patients.
- Do stay in contact with the pharmaceutical company.