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Access to full and properly structured data from clinical trials can benefit the biopharmaceutical industry by improving the efficiency of drug development, enhancing comparative-effectiveness analyses and reducing duplication of effort among trial sponsors, officials from the European Medicines Agency (EMA) insist.
“A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders,” said representatives from the EMA, including senior medical officer Hans-Georg Eichler and executive director Guido Rasi. They shared their thoughts in an article published recently in the New England Journal of Medicine.
They agree that the current rate of costs is not sustainable. The timelines and costs of clinical drug development “are increasing relentlessly, and the attrition rate of assets in development remains high”, they note.
At the same time, “growing cost pressures in all healthcare environments are forcing restrictions on drug use, aiming to limit coverage only to patients who can be expected to benefit from a given intervention and for whom that intervention is clearly cost-effective”.
Addressing industry concerns over privacy, Eichler et al said that standards for hiding personal data “are available and continue to evolve to ensure adequate protection”. Legally binding data-sharing agreements can provide an additional level of protection, they point out.
You can read more here on the PharmaTimes website.
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