n the wake of a clinical trial in France that recently left one person dead and five others hospitalized, the European Medicines Agency has begun a review of its guidelines for so-called first-in-human studies.
The review, which is being coordinated with the European Union, is supposed to identify which existing guidelines need to be revised in order to avoid a repeat of the tragedy, and a report is expected to be completed by July. The effort will also examine data needed to ensure these studies are designed correctly, according to an EMA statement released on Friday.
The drug tested in France was being developed as a treatment for chronic pain for people with cancer and other ailments. Four days ago, French authorities partly blamed the clinical research organization and drug maker involved in the fiasco for various lapses.
France’s social affairs inspectorate, known as IGAS, concluded the CRO, Biotrial, overseeing the study failed to properly manage testing, continued to administer the drug even after one patient was sent to the hospital, and failed to confirm patient consent before running the trial.
As we have reported previously, the episode focused attention on the lack of public reporting of early-stage clinical trials. The issue was highlighted because there was little known about the drug that was being tested in France and anxieties were heightened because Bial, the Portuguese drug maker, disclosed very little about its medicine even after the patient reactions came to light. French authorities, in fact, have said little themselves about what, if any, role the drug played in the debacle, other than that there were dosing issues.
To what extent the EMA review will encompass this concern is unclear. The issue was not addressed by French authorities and there is no mention in an EMEA statement discussing the review about such disclosures. So we asked the agency for comment and will update you with any reply.
The agency did say that two groups are being formed to assess guidelines. One group will look at preclinical matters and the data needed from lab tests or animal studies to safely initiate first tests in humans. The other group will look at clinical aspects of first-in-human trial designs and how these could be improved to better ensure the safety of human volunteers who participate in the studies, according to the EMA statement. A public meeting is expected to be held later this year.
The EMA also noted that severe adverse reactions in healthy volunteers, such as what occurred in the trial in France, are “extremely rare.” Since 2005, about 14,700 Phase I trials, which involved 305,000 participants, were conducted in the EU, and these included 3,100 first-in-human studies, the agency said, adding that only one other severe incident has been reported during that time in the EU.