Clinical Trials & Regulatory Affairs
Advancing Regulatory Framework with AI: A Step Towards Quicker Medication
While extending treatment protocols and refining systematic processes within the healthcare industry presents immense promise artificial intelligence (AI) comes along with multiple benefits. It would arrive at accurate diagnoses of diseases help generate personalized treatment plans facilitate corporate interactions in healthcare systems and benefit both patients and healthcare organizations. With the evolving trends in AI the healthcare domain expects to see substantial effects in the coming few years hence calling for strong regulation to ensure the protection of human ethics and practical application. The establishment of common regulatory frameworks will enable responsible usages of AI while accentuating patient rights and privacy concerns. AI is changing how drug approvals are done through positive interventions on both the time and cost aspects.
Whereas traditional drug development takes anywhere from 5.5 years to 14.5 years AI has shortened this time frame for target discovery to a preclinical candidate to as little as 18 months. Furthermore AI has reduced development costs by nearly 50% thus rendering development more efficient while enhancing the accuracy of predictions of the efficacy and safety of drugs. The stepped integration of AI into drug approval processes accelerates innovations by providing cost-effective solutions and enhancing precision that eventually benefits both patients and healthcare organizations.
Efficacy of Nanofiber Mats Loaded with 5-Fluorouracil and Rosemary Extract on Actinic Keratosis: A Randomized Double-blinded Clinical Trial
Actinic keratosis (AK) is a precancerous skin condition caused by abnormal growth of epidermal keratinocytes. Current treatments like 5-fluorouracil (5-FU) cream have limitations. Rosemary extract has shown anticancer and antioxidant properties enhancing the effects of 5-FU. Nanofibers are a potential drug delivery system due to their unique properties. Thus this study aimed to investigate the efficacy of 5-FU and rosemary extract-loaded nanofibers in AK treatment.
Polymeric nanofibers loaded with 5-FU and rosemary extract were created using electrospinning. A randomized controlled double-blinded clinical trial was conducted on AK patients divided into three groups: Group A (nanofibers with 5% 5-FU and rosemary extract) Group B (nanofibers with 5% 5-FU) and Group C (5% 5-FU cream). Improvement satisfaction and side effects were assessed using visual analogue scale (VAS) scores and the modified Investigator Global Improvement Score.
Group A exhibited significantly higher global improvement scores compared to Group B (p value<0.001). Group A also had the highest VAS score indicating greater patient satisfaction. Side effects were lowest in Group A and highest in Group C.
This randomized double-blinded clinical trial suggests that nanofibers loaded with 5-FU and rosemary extract (Group A) are more effective in improving AK lesions compared to nanofibers with 5-FU alone (Group B) and 5-FU cream (Group C). Group A also showed higher patient satisfaction and fewer side effects. The combination of 5-FU and rosemary extract in nanofibers holds promise as an alternative treatment for AK. Further studies are needed to validate these findings and investigate the long-term effects of the treatment.
IRCT20210118050067N1.
Acknowledgements to Reviewers
Applied Drug Research, Clinical Trials and Regulatory Affairs
Applied Drug Research Clinical Trials and Regulatory Affairs is an international journal with vast readership and contributions that are scientific original relevant innovative and statistically validated. The journal aims to further bridge the gap in the publication of clinical drug development biotherapeutics and regulatory affairs between high growth and potentially growing regions.
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Applied Drug Research Clinical Trials and Regulatory Affairs is an international peer-reviewed journal on all aspects of drug research clinical trials and regulatory affairs published continuously (print & online) by Bentham Science Publishers.