Talking globalization, adverse events, and successful sites at the Drug Information Association annual meeting.
By Ann Neuer
SAN DIEGO—At the DIA annual meeting in San Diego in June, clinical trial professionals met to discuss what’s working, and what’s not, in the clinical trials space.
Many conversations centered on the role of the investigative site in clinical trial operations. The site is the end user of clinical trial technology, so there is a need to better understand how it operates if its performance is to improve. Newly released versions of electronic data capture (EDC) tools boast simplicity as the best way to engage sites in collaborative efforts with sponsors and contract research organizations (CROs) seeking better performance. Steve Powell, Phase Forward, said, “Everyone is battling for the investigator space. The simpler you make it for them, the more beneficial it is for the sponsor running the trial.”
Another trend focused on data management across the enterprise and the growing emphasis on standards. Terek Peterson of Octagon Research Solutions commented, “There is a stabilization of CDISC standards—including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). Some companies are somewhat resistant to adopting standards as it is disruptive to their process, but after years of talking about it, people are adopting standards.”
Carmen Gonzalez, with Healthcare Communications Group, noted what was missing: “What wasn’t present this year is the growing impact of social media. We know the patients are there, but we need some guideposts so we can do a good job using social media.”
Globalization was a central topic, the most visible example being presence staged by the Federation of Indian Chambers of Commerce and Industry (FICCI). From the Indian Pavilion in the Exhibit Hall to dedicated sessions to a special “India evening” featuring representatives from the Office of the Drugs Controller General of India (DCGI)—the Indian regulatory agency—the FDA, and industry, it was clear that India is positioning itself to be a major player. Dan McDonald, VP business strategy, Excel Life Sciences, a trial management organization focused on India, said the country is en route to being an accepted clinical trials locale. “Two or three years ago, there was a lot of misconception about India. But now, it’s a destination that people consider.”
McDonald’s observation is supported by the FICCI. According to company, the percentage of global clinical trials in India is estimated to be 8% in 2009, and forecast to jump to almost 14% by 2011, a 75% increase in two years.
At the India Evening, panelists discussed this growth as part of the country’s vision of making India a global hub for pharmaceutical innovation. Much of this effort is slated to happen through government initiatives aimed at encouraging public-private partnerships. Murali Nair, a partner at Ernst & Young India, explained, “We will shortly be commencing work for the Indian government regarding what should be its focus and role in this effort.”
One of the most telling developments that India is a growing force in the pharmaceutical sector is the recent opening of two FDA offices in that country—one in New Delhi, the other in Mumbai—eventually employing a dozen people. The offices provide technical experts and inspectors in regulated product areas such as drugs, devices, and food. Although their responsibilities extend well beyond the realm of clinical trials, the offices are expected to be a major plus in terms of working with Indian government authorities to ensure the quality of clinical research from India coming to FDA.
According to David Lepay, FDA’s senior advisor for clinical science, the new offices are already proving valuable. “They have provided a communication channel to establish interaction, and over the past few months, we have had a very productive interaction with the DCGI office.” Lepay said the Indian regulators have asked the FDA for help in setting up systems of clinical trials oversight and inspection that are compatible with international standards.
As always, patient safety and adverse event reporting was another hot topic. Michael Ibara, head of pharmacovigilance information management at Pfizer, chaired a session on a highly original pilot study focused on a simple way for busy clinicians to report adverse drug events (ADEs) to MedWatch, the FDA’s safety information reporting program. The study, named ASTER—ADE Spontaneous Triggered Event Reporting—has just wrapped up its three-month pilot, which was conducted earlier this year at two Partners HealthCare hospitals in Boston: Brigham and Women’s and Massachusetts General Hospital (MGH).
“This was a proof of concept study involving real doctors and real patients. Our intent was to create a new business model using digitized data from electronic health records so doctors could quickly and easily report adverse events.” Ibara says.
Ibara, through Pfizer, collaborated with other institutions with a strong interest in improving patient safety. His colleagues included Jeffrey Linder, representing Partners HealthCare, and principal investigator on the study; Landen Bain of CDISC; and Lise Stevens of FDA. CRIX International, a not-for-profit organization dedicated to building a common electronic infrastructure for the clinical research industry, provided the technology that enabled the information to be forwarded to FDA.
Linder explained that 26 doctors with affiliations at either Brigham and Women’s or MGH were selected to participate in the study. Doctors were chosen based on two main criteria. “These are doctors who are very busy and who discontinue a lot of drugs in patients due to adverse events,” Linder said. Despite their workloads, these doctors were keen to participate provided the reporting was straightforward.
The ASTER study signaled doctors electronically when they entered information into the electronic medical record about a patient discontinuing a medication due to an adverse event. At that point, a pre-populated form would pop up requesting the outcome of the event (death, hospitalization, etc.), and the earliest date of the adverse event. Once complete, the doctor would hit “OK”, and the data would be sent off. Packaged with it would be additional information taken from the medical record, such as the adverse reaction, other medications taken by the patient, demographic data, and laboratory results.
Training was minimal; after a few attempts it took the doctors less than a minute to fill out the form. According to Linder, “We did a survey at the end, and overwhelmingly, they said, ‘This is great. It was fast, and didn’t interrupt my workflow at all.’”
This article also appeared in the September-October 2009 issue of Bio-IT World Magazine.
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