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By Salvatore Salamone

December 15, 2002 | Contract clinical research organization Emissary Inc. has introduced TeamTrials, a Web-based software platform that takes a novel approach to entice doctors to participate in clinical trials.

TeamTrials combines electronic data capture (EDC) features with utilities, such as time cards, expense reports, faxing, and patient record tracking, that doctors can use to better run their practices. Combining EDC with these tools serves several purposes: It gets doctors into the habit of regularly entering patient data electronically; it makes patient data available in the appropriate format for new trials; and it helps both Emissary and the doctors recruit patients for clinical trials.

Like many contract research organizations (CROs), Emissary believes EDC tools help expedite trials. While most CROs simply give doctors a new turnkey EDC computer system or new EDC software, Emissary takes a different approach, and instead gives a doctors a suite of tools they need to run a practice, with the added feature of EDC.

While useful once all a trial’s patient data is submitted, EDC does not help in the early trial stages involving patient and doctor recruitment and patient qualification screening. The TeamTrials service promises to fix this.

Pharmaceutical companies and CROs spend a great deal of time recruiting and qualifying patients for drug trials. A study by the consulting and clinical training company Barnett International Inc. found that in 400 trials, patient enrollment took, on average, about 22 percent of the total time to conduct a clinical trial. Additionally, Cap Gemini Ernst & Young found in a separate study that 80 percent of clinical trials run late because of delays in recruiting participants.

To minimize delays and help improve their overall clinical trial performance, life science companies are increasingly turning to EDC tools, which can help a doctor submit relevant patient data and prove a patient’s medical conditions match the trial’s protocols. For example, a trial might require that the patient have suffered a class III heart failure and that the doctor has seen the patient within the last three months. If a doctor were using an EDC system, he or she would be able to quickly cull this information for their records and submit it to the CRO conducting the trial.

However, one shortcoming of EDC tools is the amount of work required on the part of the doctor. “EDC doesn’t do much for speeding up recruitment,” says Steven Mayo, CEO and founder of Emissary. “Doctors do not want to do data entry.”  Mayo notes that many doctors still track their patients with paper-based systems. And those who use computer systems find “they can’t pull the data out for submission for clinical trials,” says Mayo.

Emissary’s approach is to give doctors TeamTrials for free to get them used to entering patient information and records. When a new trial starts, this information would be readily available for the doctor to submit to the CRO to enroll the patient into that trial.

Additionally, with such patient information already entered into the TeamTrials system, when new trials are getting under way Emissary can scan across all the doctors in its network and get blind information about the numbers of patients each doctor has that meet the protocols of that specific trial. Emissary runs this service for the doctors it recruits for clinical trials.

Emissary is putting TeamTrials to the test in the Novoste Corp. BRAVO (beta radiation for treatment of arterial-venous graft outflow) trial to test the safety and efficacy of the Novoste Corona System. Managed by Emissary, the Novoste clinical trial will have about 230 patients from more than 20 medical centers in North America and Europe.

Commenting on questions faxed to her, Pia Mikkelsen Lynch, Novoste’s vice president of global clinical affairs, said that “Emissary’s contribution in this trial is to assist us with monitoring and clinical trial management using their proprietary electronic data capture system, TeamTrials.” Lynch went on to note that Novoste believes the system will “help facilitate rapid enrollment in this important clinical trial.”

 



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