News on clinical trials
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Short-fall of drugs after short-fall of physicians?
The Hungarian Association of Innovative Pharmaceutical Manufacturers is ready to initiate negotiations with the Government on the possible solutions. The Association of Innovative Pharmaceutical Manufacturers sees no further possibility for restrictions in drug reimbursement. However, the Association is ready to negotiate with the Government on the possible solutions. In the past years governments have all the way up the line reduced the money spent on drug reimbursement: Continuous access to treatment was only ensured by increasing the extra taxes and pay-back inflicted on the pharmaceutical companies. According to the Association of Innovative Pharmaceutical Manufacturers as a result of these measures the level of public spending on [...]
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EU Clinical Trials Directive Leading to Dramatic Decline in Clinical Trials, Says UK Cancer Charity
Cancer Research UK claims the Clinical Trials Directive has resulted in a “huge expansion in bureaucracy” that has almost doubled the cost of its drugs programme. Since the directive was introduced in 2004 the UK’s share of trials across the world has dropped from six to two per cent. Drugs firms have started to pull jobs out of Britain as a result, according to Professor Peter Johnson, the charity’s chief clinician. He said: “We are driving a Rolls Royce organisation down a cart track, in terms of the bureaucracy and impediments that we have to overcome along the way. ”The directive [...]
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Dilemma: When 1 Drug Treats 2 Diseases
A drug used to treat multiple sclerosis has also been shown to slow the progression of Lou Gehrig’s disease in mice, a nonprofit biotechnology company plans to announce Tuesday. Now, scientists face a dilemma. Many patients with Lou Gehrig’s disease, a fatal disorder formally known as amyotrophic lateral sclerosis, may want to try the drug on their own—even though there’s no evidence that it is safe or effective in patients with the disease. But scientists want patients to enroll in a clinical trial, one that specifically examines how the drug, Gilenya, works in people with ALS. They hope to launch [...]
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Where Have All The Unreported Clinical Trials Gone?
Last month, a series of studies published in BMJ reported various problems with clinical trial data. More specifically, there is a lot that goes unpublished. Although the Food and Drug Administration Amendments Act requires mandatory reporting of summary clinical trial results within one year of completion on ClinicalTrials.gov, one BMJ paper found that only 22 percent adhered to the mandate. And so a trio of House Democrats – Henry Waxman, Ed Markey and Diana DeGette – has written FDA commish Margaret Hamburg and National Institutes of Health director Francis Collins to ask what these agencies are doing to enforce the [...]
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Ockham has expanded its oncology trial services offering through its acquisition of Nexus Oncology
Ockham said the takeover, completed this week, was a direct result of increased demand from its clients who want a more complete service as they move towards later phase clinical studies. Full article.
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Driven by loss, father inspires tireless pursuit of a cure
Last week, the Food and Drug Administration issued an announcement with a title only a federal bureaucrat could write: “FDA approves Kalydeco to treat rare form of cystic fibrosis.’’ In fact, it was a blockbuster development, the first drug that would treat the cause, rather than the symptoms, of cystic fibrosis, a medication that showed such breathtaking results in clinical trials that it was sanctioned by the FDA in about half the typical time. Behind that announcement sits a human narrative, a quarter century in the making, of loss, hope, and triumph. Read the full story here.
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Russian trial approvals up in 2011, but reviews still slow says ACTO
Russia’s trial sector has largely recovered from the ‘crisis’ created by revision of approval system in 2010, but regulators are still taking too long to OK studies says industry group ACTO. According to report by the Moscow-based Association of Clinical Trial Organization’s (ACTO) the Russian Ministry of Health (MoH) approved 567 studies in 2011, 17.6 per cent up on the previous year, with a record 370 international multicentre clinical trials (IMCT) being given the green light. For the full article please click here.
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Journals aim at recruitment & data in trial transparency push
Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim. Read article.
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New online patient recruitment unit will streamline process, says Quintiles
Quintiles says it will streamline its patient recruitment model with a new digital unit. The clinical service provider said the new resource will create an online community of people willing to participate in trials and thereby accelerate recruitment. Read the full article here.
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“Science” Names HIV Prevention Trial As Breakthrough Of The Year
Science named the HIV Prevention Trials Network (HPTN) 052 study “Breakthrough of the Year.” FHI 360 congratulates our HPTN 052 collaborating partners on this important achievement. This is the second year in a row that Science selected a trial for which FHI 360 provided scientific leadership and operational support. Last year, the CAPRISA 004 study was recognized as one of Science’s breakthroughs of 2010. Read the full article here.
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