Planning a major meeting in three months is difficult enough, but when a pharmaceutical company hires Kendle International Inc., a contract research organization in Cincinnati, Ohio, to handle its clinical trial of a new drug, there's a lot more involved than the usual conference logistics. Sharyn D'Souza, PhD, Kendle's senior project manager, is responsible for not only coordinating the first investigator meeting--the program that brings together all the participating physicians--but she also oversees the myriad of complex tasks involved in launching a trial, from developing case report forms to ensuring the study follows FDA regulations.

It takes an average of 15 years and about $300 million dollars to bring a drug to market. By the time a pharmaceutical company is ready to launch a clinical trial, where doctors test the drug on patients, the drug has been through years of development. It is during the clinical trial that companies collect and analyze the data that will be published in journals and presented to the FDA for drug approval. In today's competitive market, companies must get the clinical trial jump-started as cost-effectively and quickly as possible.

But trials also must be done right. Investigator meetings are the nucleus of clinical trials--the success of the study depends on them. Investigator meetings are where doctors get hands-on training in every aspect of the study. Presenters go over reams of data, ensuring that physicians comprehend every detail. If doctors don't comply with the protocol, they can jeopardize the whole process.

Investigator meetings touch on many aspects of the medical conference industry. Corporate meeting managers, independent planners, communications companies, academic CME departments--all are players. And even if you aren't involved in organizing these events, you may find yourself next door to one--investigator meetings are sometimes

scheduled in conjunction with a national medical society's annual convention. And investigator meeting planners cope with many of the same challenges faced by any medical meeting organizer--tight budgets, ethical gray areas, and demanding physicians. Here are the experts' strategies for successful investigator meetings.

Laying the Groundwork Contract research organizations (CRO) such as Kendle are the specialists in investigator meetings. Pharmaceutical firms typically subcontract trials to a CRO, which then often subs out the meeting logistics to a conference management firm. Communications companies, which usually for-mulate promotion and educational campaigns for drug companies, are also staking out a share of the market.

At initial investigator meetings, physicians receive training and discuss modifications to the protocol. Interim meetings allow physicians and other health care professionals involved in the trial to review findings and solve problems. Depending on the size of the study and the stage it is in, anywhere from 100 to several thousand participants may be invited. Investigator meetings must be brief--one to three days, usually over a weekend, to accommodate physicians' increasingly hectic schedules--but also extremely thorough.

D'Souza's challenge is to kick off these trials within her clients' tight time frames. Fortunately, finding physicians to participate is not hard, she says, because of Kendle's reputation in the medical community. "We know many of the investigators better than the sponsors do," D'Souza says. "Word spreads through the grapevine and we get lots of calls [from physicians] asking to participate." Doctors are especially excited if the trial involves a therapeutic area where current medications are not effective. "Physicians are eager to try something new that might help their patients," she says.

On the other hand, the pool of potential investigators is not bottomless. Usually, only the top physicians in the field are asked, but not all are willing to expend the enormous amount of time and effort it takes to participate. Pharmaceutical companies compete for first-rate investigators--and project managers must convince physicians that working with their study will be a positive experience. That means, says D'Souza, nurturing long-term relationships with the investigators.

Physicians as Guests When they sign on as investigators, physicians become, in effect, consultants of the company. As such, it is perfectly acceptable, ethically speaking, for the company to cover conference expenses and pay honoraria. But that's not enough. Planners must take physicians' needs into account every step of the way to facilitate their continued commitment.

"They are your guests, and you have to take care of them," says Toby Joseph, vice president, meeting and event management, OCC North America, Inc., a communications company based in Newtown, Penn. OCC sends out questionnaires asking doctors when they prefer to fly and whether they are under dietary restrictions. OCC keeps profiles of attendees on record. "Remembering their special needs makes them willing to attend [meetings]," she says.

Planners also act as intermediaries. "We are on the front line of communication between the physician and the pharmaceutical company," says Joseph Lipman, president of Summit Management Services, a meeting planning firm in Cedar Grove, N.J. "We are responsible for taking care of the uncomfortable situations."

For example, a physician may balk at flying the most economical airline because the schedule is not convenient. In those cases, D'Souza, acting as the physicians' advocate, will ask the pharmaceutical company for permission to book a more expensive flight.

Convenience and Comfort Convenience is also the first consideration when choosing a venue. D'Souza looks for easy air access and a quick transfers. After considering all the factors, she usually picks four-star hotels in downtown or resort locations; recent choices include Chicago and Phoenix. She prefers hotels that have experience handling investigator meetings and that understand the security issues and unusual requirements involved. For instance, she may need to set up phone banks so physicians can be trained to use Kendle's telephone reporting system.

Convenience may be the first consideration, but planners acknowledge that physicians prefer superior service and plenty of amenities. While many organizers follow the American Medical Association's Ethical Opinion on Gifts to Physicians, which says that meals and lodgings at conferences should be "modest" (see Walking the Line, page 37), there is nothing inherently wrong with choosing a classy venue. "You send them to a nice place, so at least they'll have a little bit of enjoyment while they are gone. They are not seeing patients; they are giving up income," says Joan Sondag Taylor, health care education consultant, Kansas City, Mo.

In fact, with the growing crunch on doctors' time and incomes, the pressure is on to select top-flight venues, says Timothy J. VanSusteren, PhD, associate dean for CME and faculty development, University of Florida College of Medicine in Gainesville, Fla. He recently convened an investigator meeting at a resort on Kiawah Island, S.C. "It was hugely expensive," he says, "but if we held it at a Holiday Inn in downtown Charlotte, we would not have had many people come."

One way to avoid spending exorbitant funds is to schedule an investigator meeting in conjunction with a medical society convention, suggests Lawrence Sherman, vice president, business development, CoMed Communications, Philadelphia. That way, physicians get their airfare covered for their association's annual meeting.

When Top Dogs Start Barking During investigator meetings, CRO and pharmaceutical company staff must present oodles of material. But it is equally important that physicians share experiences. "A key part of the learning process is that everybody is encouraged to ask questions," says D'Souza. In fact, the Q&A sessions are so valuable that Kendle records them and sends them to the investigators after the meeting.

The pharmaceutical company also needs to hear from investigators, says Sherman. Does the protocol need revising? Should the case report form be altered? Such discussions can get volatile, Sherman cautions. Investigators may criticize the company's methods or argue about researchers' data analysis. Investigators--the top dogs in their field--may be competing with each other. But despite the ego flares, open forums are critical to success, Sherman says.

Set aside a couple of hours at the end of the meeting, Sherman advises, and delve into the minds of the investigators; solicit their ideas for how to best market the drug. "Investigators want to be treated as partners," he says. "They have opinions. They want to be heard." Firms give themselves a competitive edge when recruiting if they promote the sense of partnership.

Personal interaction is so important that D'Souza won't use technology to replace live meetings. Even though planners say they are getting more requests for videoconferences, and some companies are doing online meetings, D'Souza holds firm, saying, "The discussions and interaction that come up at meetings cannot be duplicated."

Virtual Investigators When Knoll Pharmaceuticals contracted the University of Florida College of Medicine, Gainesville, Fla., to conduct a clinical trial for a cardiovascular drug, the challenge was daunting. The study involved 10,000 investigators across the U.S., Great Britain, Germany, France, Spain, and Italy.

"It would be almost impossible to have a meeting with so many investigators scattered over the globe," says Timothy J. VanSusteren, PhD, associate dean for CME and faculty development with the college. So, VanSusteren and his staff came up with an unusual approach--they launched the study online. They enticed investigators with an incentive--a free computer, which was theirs to keep after the trial. Technicians installed the computers in doctors' offices, and trained the physicians to use them. The computers were loaded with the study protocol and all the information investigators needed.

"The plan was that the doctor could enroll the patient, using the computer, in ten minutes," says VanSusteren. The medications were then mailed directly to the patients. The computer replaced the nurse who would ordinarily interview the patient.

The study is in its second year, with one more year to go. The biggest obstacle, says VanSusteren, is "there's a large group of docs that just aren't interested in computers." Some doctors have taken the computers home; others can't figure out how to use them, even though they've had training.

Nevertheless, says VanSusteren, "In-person investigator meetings are becoming more expensive, and it's more difficult to get docs to attend. We did this because we really believe the [clinical] trial of the future is going to be Internet-based." He predicts that the college will conduct more trials online, but adds that face-to-face investigator meetings "may never go away." In fact, VanSusteren has convened about eight meetings during this trial, bringing together small groups to go over data or address problems. He acknowledges that there are many investigators whom he has never even talked to, and while that is not unusual during large, international trials, the electronic format, he reflects, "adds another level of insulation."

Very Hush-Hush With hundreds of millions of dollars at stake, drug companies make all-out efforts to protect their data. Investigator meeting veterans have these suggestions to ensure confidentiality.

* Select properties that have experience handling the security requirements for investigator meetings.

* Add a clause to the hotel contract stipulating that no other pharmaceutical companies can book the property during your investigator meeting without your permission.

* Look for a staff-to-attendee ratio of one per 50 or 60 to ensure that no materials or meeting rooms will be left unattended.

* Insist that name badges are worn at all times, and consider barring spouses/guests from functions.

* Destroy all confidential materials at the completion of the program.

Investigator meeting planners walk a fine line, motivating physicians to attend meetings without crossing into ethical gray areas. Many say they adhere to AMA and FDA guidelines, and also follow the drug firms' internal policies, but, increasingly, there are reports of ethical violations. Industry veterans point to instances where pharmaceutical companies have taken physicians on week-long junkets, where perhaps an hour or two is devoted to "consulting." Or firms have convened "investigator meetings," which are really forums for promoting new drugs to physicians.

According to the AMA's Ethical Opinion on Gifts to Physicians from Industry, when physicians are consultants to a company--as is the case during a legitimate investigator meeting--they can expect to have their expenses covered and receive honoraria. But that does not give the physician carte blanche. Compensation, travel, lodging, and meals should all be "reasonable," state the guidelines.

Industry leaders speculate that ethical violations may be on the rise because it's been 10 years since the AMA issued its guidelines and some in the industry have grown lax. It's time to re-examine the guidelines, says says Robert M. Tenery, MD, chairman of the AMA's Council on Ethical and Judicial Affairs. This month, the AMA is convening a meeting of representatives from various constituencies of the health care industry to create a task force that will map out ethical guidelines that apply across the board. "The AMA has issued its opinion on physicians' behavior," Tenery says, "but we can't tell [pharmaceutical firms] how to act." An industry-wide initiative, he says, is what is needed now.

For a copy of the AMA's ethical guidelines, or more information, call (312) 464-4671 or visit www.ama-assn.org.