By Mark D. Uehling
March 10, 2003 | David Isralowitz is an internist in Rutherford, N.J. He's participated in a few clinical trials, but felt crushed by paperwork.
Dr. Isralowitz changed his mind when approached by a new recruitment-enabling company, MedAvante Inc. "I can treat the patients, see them progress," Isralowitz says, "and not get involved in the paperwork. It was just overwhelming."
MedAvante, based in Princeton, N.J., hopes to use teleconferencing to fix a fundamental problem with clinical trials: the chronic shortage of volunteers. The company's goal is to give the sponsors of clinical trials all the human guinea pigs they need in less than the eight months it now takes, on average, to populate a trial.
To expedite the process, MedAvante plans to go straight to doctors like Isralowitz who see dozens of patients a day. Those physicians, MedAvante hopes, will recruit all the patients drug companies need once its teleconferencing technology has resolved two thorny issues: armloads of paperwork and the potential to lose patients when they travel to see specialist physicians interviewing candidates for clinical trials. The system will rely on two 15-inch flat-panel screens and peripheral devices displaying a patient's vital signs. Initially, the connection will run over six linked 384-kilobit/second ISDN lines. As needs grow, the traffic will shift to a virtual private network facilitated by Groove Networks.
Either way, MedAvante hopes the technology will impress community doctors (each of whom may have 2,500 patients in their files) into enrolling those patients in clinical trials. "Our goal is to find appropriate patients wherever they are by removing traditional barriers to participation," says Paul Gilbert, MedAvante marketing vice president.
The New Jersey startup has just eight employees, and has yet to facilitate its first trial, but a heavyweight advisory board of former pharma execs like a former chief scientific officer of Eli Lilly and Co. and a former CEO of Hoffman-La Roche) could help it avoid the most glaring missteps.
Traditional patient recruitment is low-tech, based on advertising. Patients responding to a mass transit or newspaper ad must diagnose themselves and then report to a clinic to see if they meet the study's criteria.The pharmaceutical industry recognizes the inefficiencies inherent in telling all of Dallas, for instance, about an insomnia study needing 17 patients, but hasn't come up with an alternative. To find out if telemedicine works, AstraZeneca Pharmaceuticals will help fund a mock clinical trial using the MedAvante technology at Columbia University. "The question is whether we can execute," says Gilbert. "They don't doubt the validity of the concept."
Show Me the Money
Part of the concept is simple: dollars. "We want to give the primary care physicians the most remuneration for the least work," says Gilbert. "They are very up front about the fact that they need an incremental revenue stream." Depending on a trial's length and complexity, MedAvante will offer physicians $600 to $2,000 per patient per study. With such blandishments -- and by giving the tedious record keeping to expert doctors -- MedAvante says it has been able to sign up most of the community doctors it has approached. It has enlisted 110 New Jersey physicians with 325,000 patients.
The technology will not be cheap, but it will be straightforward. It will cost about $15,000 to outfit each physician office that needs the Polycom Inc. teleconferencing gear.
Telemedicine setups are common in the military and rural America. The MedAvante twist is that the company takes no position on electronic data capture (EDC), in which nurses or patients record clinical facts on computers, avoiding errors and record-keeping issues associated with pen and paper. These days, a clinical trials vendor not working with EDC is as common as a fast-food chain not working with beef.
In its defense, MedAvante says it wants to be able to collaborate with all comers, using whatever paper- or EDC-based infrastructure a study site prefers. The specialist physicians who run clinical trials use a plethora of paper forms, hardware, and software, most of which has long defied attempted improvements by hospital and university IT departments, not to mention consultants and vendors.
MedAvante is deferring to existing data-collection norms to such an extent that a key part of its pitch--reducing paperwork hassles--becomes hard to evaluate. Traditionally, the majority of physicians who participate in one clinical trial never sign up for another. If MedAvante can retain physicians at the community level, it will be a sign the bureaucracy is not too onerous and the teleconferencing equipment works.
Glitches aside, even boosters of telemedicine say MedAvante will not be able to count on everyone cooperating. Some patients have suspicions about technology -- or about doctors taking shortcuts to save money. "Patients will vary in their willing-ness to use the technology," says Richard L. Street, a communications professor at Texas A&M University. "There are some patients who will say, 'I am not going to do this.'" Street notes that just aligning the schedules of a patient, a primary care doctor, a specialist doctor, and a telemedicine suite could be a big challenge.
But it sounds like one of the key ingredients to success in telemedicine is already in place at MedAvante. "We're dealing with people, with relationships," says Street: "The problem with a lot of the telemedicine advocates and proponents is that they are too machine oriented and they are not relationally oriented."
On the relationship front, MedAvante is being built around uniting community doctors and their colleagues in universities. The primary care doctors, after all, have seen an unknown percentage of patients disappear after getting to know the expert doctors running clinical trials. Stopping that poaching -- if patients have no need to travel to the experts -- is crucial if MedAvante hopes to win the trust of community doctors.
Beyond the numbers of patients, the crux of the MedAvante pitch is better data. As drug companies have known for years, most physicians in clinical trials struggle to sign up, say, 100 extremely hard-to-find women with a specific type and stage of colon cancer and all meeting exacting demographic and medical criteria.
As the deadline for finding 100 patients approaches, some physicians will fudge the eligibility. Perhaps a certain patient does not perfectly meet the study guidelines but is close. Inappropriate patients will not respond to the drug being studied in the same manner as the rest of the patients, so data quality suffers.
If telemedicine-based recruitment works -- if doctors are not forced to include borderline patients -- fewer patients could be needed overall. That could mean faster, cheaper clinical trials. It might even mean drug companies need to recruit fewer specialist doctors to run the trials. "Because you're choosing your best principal investigators," says Gilbert, "you're going to have better data collection."
And the patients? Some might like the spotlight. "We were surprised," says Livingston Johnson, chief information officer at MedAvante, recalling a recent pilot project to test the technology at North Shore Long Island Jewish Hospital. "Some of these patients are much more comfortable talking to the remote assessor via telemedicine than they were talking to a doctor face to face."