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Harnessing AI and Real-World Data: The Future of Clinical Development

PPD

The pharmaceutical industry is currently experiencing a significant transformation. The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. With good performance, these algorithms can then be used to maximize use of existing secondary sources.

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Patients report improvement in haemorrhoid treatment trial

Drug Discovery World

Citius Pharmaceuticals has revealed positive results from its Phase IIb Study of Halo-Lido (CITI-002) for the treatment of haemorrhoids. Following the 21 st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (PRO) instruments in clinical trials.

Treatment 130
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Drug’s unique mechanism of action targets schizophrenia abnormalities

Drug Discovery World

Newron Pharmaceuticals has reported new findings of mechanism of action that indicate its drug candidate evenamide could be uniquely effective in patients with treatment resistant schizophrenia (TRS).

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$5 million to fund trial of immunotherapy for uveal melanoma

Drug Discovery World

Cancer Focus Fund is investing $5 million in funding to support ISA103, ISA Pharmaceuticals’ PRAME-targeting immunotherapy, in a first-in-human study for the treatment of uveal melanoma, a rare ocular cancer. . A total of 90 patients will be enrolled in the trial. .

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Pfizer launches Phase III trial for Lyme disease vaccine  

Drug Discovery World

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. February 2022.

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The Growing Role of CROs in Clinical Trials

PPD

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.