International drug development processes and policies are responsible and need to be reformed – ScienceDaily

Beate Wieseler and her colleagues from the German Health Technology Assessment Agency IQWiG (Institute for Quality and Efficiency of Health Care) state that the processes and policies for the development of International medicines are responsible and need to be reformed.

Between 2011 and 2017, IQWiG evaluated 216 drugs entering the German market after regulatory approval, they explain. Almost all of these drugs have been approved by the European Medicines Agency for use throughout Europe.

Yet only 54 (25%) were found to have a significant or major additional benefit. In 35 cases (16%), the additional benefit was either minor or impossible to quantify. And for 125 drugs (58%), the available evidence did not prove an additional advantage over standard care in the approved patient population.

The situation is particularly shocking in some specialties, they add. For example, in the areas of psychiatry / neurology and diabetes, additional benefits were demonstrated in only 6% (1/18) and 17% (4/24) of badessments, respectively.

Some people have argued that the limited information at the time of regulatory approval (and therefore the widespread use by patients) is the price to pay for rapid access to innovative drugs, explain the authors.

The reality, however, looks very different. For example, an evaluation of cancer drugs approved by the EMA between 2009 and 2013 showed that most had been approved without any clinically significant benefit on patient-relevant outcomes (survival and quality of life) and that few Years had changed.

In addition, post-marketing studies are often not realized and at the global level, regulators do not punish non-compliant companies, they write.

Evidence also suggests that many of the drugs studied add benefits only to subgroups of patients. "For the entire patient population, the current results of drug development could therefore lead to even less progress than those suggested by our evaluations," say the authors.

Clinicians and patients deserve unbiased and comprehensive information about what to expect from a given treatment, including information about the benefits of substitution treatment or lack of treatment, write the authors. But given the current information gaps, this is not possible.

"As a result, the ability of patients to make informed treatment decisions, consistent with their preferences, could be compromised, and any health system that hopes to call" patient-centered "is failing ethical. "

They believe that regulators should become much less tolerant of shortened drug development programs and require strong evidence of long-term randomized controlled trials that are large enough to prove efficacy and effectiveness. 39; safety.

The missing information could still be filled by an obligation to conduct active controlled trials, they add. While reimbursement and pricing decisions "should avoid encouraging patients to achieve marginal results or results based on highly uncertain evidence, but rather rewarding the achievement of relevant results."

In the longer term, health policy makers need to take a more proactive approach, they write. "Rather than waiting for the pharmaceutical companies to determine what they will develop, they could define the needs of the health system and implement measures to ensure the development of the required treatments."

They conclude: "A combined action at European and national level is needed to define public health goals and to revise the legal and regulatory framework, including by introducing new drug development models, to achieve these goals and focus on this. which should be the main priority of health care: the needs of patients. "

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