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25 Ocak 2014

FDA ilaç onaylarında standart davranıyor mu? SocialDoctors İçerisinde Paylaş

Kaynak: USA Today, U.S. News & World, The Wall Street Journal, Bloomberg, Breitbart, The Washington Post, JAMA

2005-2012 arasında yapılan çalışmalar bakılmış. Genelde 206 toplam endikasyonda her endikasyon başına 2 çalışma varken, 74 endikasyon 1 pivotal çalışma ile onay almış.  Çalışmaları %89.3’u randomize iken, %79.5’i  çift kör, ve %87.1’i aktif ya da plasebo ile karşılaştırmış. Çalışmalar alınan hasta sayısı 270-1550 arasında.
 
68 endikasyonda 6 aydan daha fazla süren bir pivotal çalışma kullanılmış. 91 çalışmada bir biyomarker son nokta. 67 çalışmada ise klinik sonuç son nokta olarak kullanılmış.
Kanser ilaçları genellikle tek çalışma ile onaylanmış. Psikiyatrik, kardiyovasküler ve diyabet ve hipertansiyon ilaçları en az 3 çalışma ile onay almış. Kronik hastalıkların çalışmaları 1 yıldan az sürdüğü için bu ilaçların uzun süreli etkinlikleri ve güvenlikleri hakkında tereddüt var.

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Ref: USA Today, U.S. News & World, The Wall Street Journal, Bloomberg, Breitbart, The Washington Post, JAMA
Study results published Tuesday in JAMA suggest there is wide variation in the quality of clinical trial evidence used by the FDA as the basis for recent new drug approvals. Senior author Joseph Ross said "some [drugs] are approved on very robust evidence, and some are based on preliminary evidence," adding that "there is a lot of nuance at the time of approval that isn't well communicated to patients."In order to characterise pivotal efficacy trials for newly approved novel therapeutic agents, investigators conducted a cross-sectional analysis of publicly available FDA documents for all such drugs approved between 2005 and 2012. During that period, the US regulator approved 188 novel therapeutic agents for 206 indications based on 448 pivotal efficacy studies. Findings showed that the median number of pivotal studies per indication was two, although 74 indications gained FDA clearance based on a single pivotal trial. The authors also noted that 89.3 percent of the studies were randomised, 79.5 percent were double-blinded and 87.1 percent used either an active or placebo comparator. The number of patients enrolled in the trials ranged from 270 to 1550, with the median number per indication among all pivotal trials being 760.The study found that at least one pivotal trial lasting six months or more supported the approval of 68 indications. Trials using surrogate endpoints, which were defined as any endpoint using a biomarker expected to predict clinical benefit, formed the exclusive basis of approval for 91 indications, while clinical outcomes were the basis for approval for 67 indications, and clinical scales for 36 indications. "This reliance on surrogate outcomes leaves patients and physicians to extrapolate clinical benefits from trials, again raising questions about the certainty of medications' benefits in practice," the researchers said, with lead author Nicholas Downing noting that many studies "were small, short, and focused on laboratory values, or some other surrogate metric of effect, rather than clinical endpoints like death." Further, study features differed by therapeutic and indication characteristics. The authors found that, for example, most drugs authorised for cancer indications were approved on the basis of a single trial, whereas drugs for psychiatric indications, cardiovascular disease, diabetes, or hyperlipidaemia often relied on at least three trials. They also found that most studies evaluating drugs for chronic treatment lasted less than one year, "raising questions about the certainty of these medications’ long-term efficacy and safety."Still, the researchers noted that the FDA's "regulatory flexibility allows for a customised approach to approval, including the ability to rapidly approve potentially effective therapies for life-threatening diseases." In an accompanying editorial, Steven Goodman said that "the FDA walks a tightrope, and until now we haven't had a huge amount of information about how they're doing that balancing act." He said the criteria used by the FDA "could be perfect, in that [the agency is] being flexible and allowing innovation and getting lifesaving drugs through to market," but that, conversely, "they could be making decisions too precipitously and allowing potentially dangerous medications through. It's a difficult balancing act that requires constant monitoring." FDA spokeswoman Stephanie Yao said that "the agency applies the same statutory approval standards of safety and efficacy to all drugs, but uses regulatory flexibility in applying those standards." Meanwhile, a third study, which was conducted by the FDA and whose results were also published in JAMA, examined why the agency delayed or rejected approval of new medications tested between 2000 and 2012. Findings indicate that these regulatory outcomes were often caused by problems with setting the correct dosage, choosing the appropriate patients to include in the trial, or establishing proper endpoints. The authors suggested that "early and frequent dialogue between the FDA and drug sponsors addressing critical aspects of study design…has the potential to reduce delays in the approval of new drugs."

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