BIOMEDICAL RESEARCHAND DRUG APPROVEDFOR MENTAL ILLNESS INTHE 21ST CENTURY

An Academic presentation byDr. Nancy Agens, Head, Technical Operations, PubricaGroup:  www.pubrica.comEmail: sales@pubrica.com

In brief

Introduction

Use of Biomarkers and Surrogate Measures

Data Summaries of Clinical Records

Conclusion

Future scope

Outline of Topics

Today's Discussion

To sum up, the 21st Century Cures Act is a ground-breakingpiece of legislation receiving tremendous bipartisan support in

Congress. The Act's important aims are impactful and willsignificantly alter future medical and healthcare research intocancer, neurology, and precision therapies, as well as supportpatients with mental health disorders and opioid dependency.

In Brief

On 13 December 2016 President Barack Obama signed the 21st Century Cures Act intolaw.

This $6.3 billion law provides resources to accelerate cancer scientific and medicalresearch through the so-called Cancer Moonshot.

Which enhance human brain understanding through the Brain Research initiative byAdvancing Innovative Neurotechnologies (BRAIN) and extend precision medicinethrough the Precise Medicine Initiative (PMI) to include all diseases.

The twenty-first Century Cures Act defines the phrase extensively and includes “anyscientific statistics concerning the usage of a drug derived from sources different thanrandomized scientific trials.”

Introduction

Use of Biomarkers and Surrogate Measures

Despite generally favourable views involving the enactment of this landmark bill into law,issues have been raised about certain elements of the legislation.

Specifically, the Act discusses the use of biomarkers, surrogate measures, affectedperson experience information, and observational records from movements clinical useor “real-world evidence” to facilitate extra speedy drug and machine approval.

Researchers regularly define real-world evidence as healthcare-related records that arederived from more than a few sources along with electronic health records, claims andbilling data, registries, and health applications.

Data Summaries of Clinical Records

Another potentially concerning difficulty is that additional wording in the Act permits forthe approval of new warning signs for existing medications to be primarily based only on“data summaries” submitted through manufacturers.

Currently, the FDA assesses all of the submitted records for new drug approvals andsupplemental indications.

Some manufacturers have been found to overestimate the benefits and underestimatethe risks of their medicine when summarizing their very own clinical records in the past.

Clinicians should be mindful of the types of documents behind acceptance, andrecognize that when designing and implementing treatment plans and patient therapy.

We strongly suggest that the funding mechanisms of the CuresAct be assessed to make sure that all men and women are in aposition to gain from the enhancements in dependency andintellectual health cure protected in the regulation.

Without a cautious interest in the funding mechanismsincluded in this legislation, the Cures Act has the conceivableto exacerbate racial disparities instead than alleviate them.

Conclusion

The 21st Century Cures Act marks a step on the right path in the U.S. because it is the firstlegislative initiative to decriminalize addiction by providing therapeutic programs.

To that end, through care and recovery services, the Cures Act adopts a public healthapproach to mental well-being and addiction, which serves as a clear departure from theapproach to criminal justice.

Absent a legislative focus on reducing the racial disparities created by the criminal justicesystem, however, the twenty-first Century Cures Act may aim to theoretically result incontinued racial inequity in health and justice.

Future scopes

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