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CLINICAL RESEARCH
Harvard Clinical Research Group Gains Reputation for Trial Design, Statistical AnalysisStroke clinics throughout the nation are currently recruiting patients for an investigational clinical trial of a device developed by the Boston-based firm NMT Medical. Called STARFlex®, the device is an implant designed to close an opening between the left and right atria of the heart. Though the implant has been in use in Europe, the firm has just recently received the FDA's approval to conduct a clinical trial in the United States.
One of the benefits that the Harvard Clinical Research Institute provides, according to its president Spencer Goldsmith (left), is that data from studies for client companies like that of John Ahern, president and CEO of NMT Medical, is available for further academic research. (Photo by Steve Gilbert) To ensure that the design, implementation, and data analysis of CLOSURE I, the moniker for the large-scale clinical trial that will assess STARFlex, would be appropriately completed, John Ahern, president and CEO of NMT Medical, did what an increasing number of executives in today's competitive medical products industry are doing: he sought assistance on trial design and statistical analysis from a clinical research organization (CRO). Organization ValuesThe CRO he chose was the not-for-profit Harvard Clinical Research Institute (HCRI), a joint venture of HMS, Partners HealthCare, and CareGroup.The pivotal question for Ahern was, "Do they design an appropriately powered study, one that demonstrates the endpoint with the statistical significance needed to pass the 'So what?' test?" "Their record in the field convinced me they do," he said. For Spencer Goldsmith, president of HCRI, that assessment sums up what he describes as the "special value" the institute provides its clients: the strength and depth needed to design and manage large clinical trials and to analyze the data produced.
This growth has mirrored similar progress in the for-profit CRO industry, said Goldsmith. HCRI, however, does offer its clients and affiliated physicians an advantage not found in the for-profit environment: access to the data. "When forced to use for-profit CROs, the clinical data reside outside of the academic institution. This means that academic researchers hoping to mine the data for journal articles, pool it for meta-analyses, or use it in other ways that would advance the knowledge base of patient care are left beholden to the CRO and its client," said Goldsmith. "At HCRI, access to the data for further scientific and academic analysis takes precedence. We provide the client with regulatory-compliant research data and retain the rights for use by our physicians for academic research purposes." The Research PriorityKey to the institute's continued growth, said Goldsmith, is its ability to recruit involved HMS-affiliated physicians. All are prominent in their chosen field, and all are serious about the quality of their research."These are individuals who are driven by science rather than stock options," Goldsmith said, noting that quality research and ethical conduct, such as avoiding conflicts of interest, are standard practice, accepted and codified in HMS's guidelines for physician behavior. The caliber of researcher that HCRI offers fits the regulatory compliance requirements that clinical studies such as NMT Medical's CLOSURE I must meet. To ensure a trial that conforms to regulatory guidelines including those governing patient confidentiality mandated in recent HIPAA legislation, HCRI's Richard Kuntz, chief scientific officer, and Paulette Niemyski, director of trial design and development, worked with NMT Medical to design a two-year randomized trial involving more than 100 clinical centers and 1,600 patients. These patients all have a common congenital defect, patent foramen ovale (PFO), an opening in the wall separating the left and right atria of the heart. As a result, they have suffered a stroke or a transient ischemic attack (TIA), exhibiting stroke symptoms that lasted less than 24 hours. Although usually not troublesome, PFOs are found in up to 50 percent of individuals who have had a stroke or TIA. The reason: the hole allows blood clots or other material that normally would be filtered by the lungs to move from the heart to the brain, causing the attack. Participants will be assigned randomly to one of two 800-member groups. One group will receive either warfarin (Coumadin), aspirin, or both. Participants in a second group will have STARFlex implanted. Encased in a catheter, the device is threaded through a vein in the groin to the heart and into the opening in the atrial septum. Designed as a double umbrella, the STARFlex device unfolds as it slips from the catheter, one umbrella sealing one side of the opening and the second umbrella sealing the other side. Once in place, the device is permanent, and in about six months, is covered by new heart tissue. Participants will be monitored for two years to see whether patients with the STARFlex device show a lowered incidence of stroke or TIA compared with patients who are receiving the medicinal agents. If all goes as hoped, NMT Medical's STARFlex will soon be available for general use, joining other products, like Johnson & Johnson's drug-eluting stent, that have been vetted by physician-researchers at HCRI. --Ann Marie Menting |
