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Ethical Aspects in Thermal Imaging Research
Published in U. Snekhalatha, K. Palani Thanaraj, Kurt Ammer, Artificial Intelligence-Based Infrared Thermal Image Processing and Its Applications, 2023
U. Snekhalatha, K. Palani Thanaraj, Kurt Ammer
Clinical trials are an important element of clinical research since they help with the discovery of new drugs and procedures, as well as the application of existing medicines and processes. Clinical trials that are well-designed and properly conducted can assist in providing answers to important questions in health care and medication development. Their findings are critical for evidence-based decision-making. Trials that are inadequately designed and/or improperly conducted may result in a negative outcome. This jeopardizes participant safety, and evidence may be insufficient or inaccurate. They squander resources and therefore waste the investigators’ and participants’ efforts and time.
Pharmogenology: The Industrial New Drug Development Process
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
The objective of all of the clinical trials is to produce clear and well-documented evidence that the new drug candidate is effective ("substantial proof of efficacy based on adequate and well-controlled clinical investigations") and is safe when used in the manner intended. A close collaboration between pharmacists and the company clinical monitors is essential to design rigorous methodology of "blinding" (all dosages made to look alike), packaging (bottles, blister packs, etc.) and labeling for these "well controlled" often "double-blind" clinical studies. It is not unusual for thousands of patients to be involved in a massive effort to provide the required proof. The completed case report forms for each of these patients must reflect, in full fidelity, the clinical experience of the patient throughout a clinical trial. These case report forms must be complete and their contents checked for accuracy against source documents. This last step is essential because it is only the data on the case report form that the sponsor has to digest, analyze, process, and tabulate. The assurance of complete fidelity of the clinical trial to the methodology of the protocol and monitoring of the quality of the data on the case report form is the responsibility of medical scientists in the company clinical research group. Mathematical processing of compilations of data from all involved patients as reported on case reports provides the basis of the claim for efficacy and safety of the new drug substance.
Clinical Test Paradigms and Problems: Human Otoprotection Studies
Published in Stavros Hatzopoulos, Andrea Ciorba, Mark Krumm, Advances in Audiology and Hearing Science, 2020
Colleen G. Le Prell, Kathleen C. M. Campbell
Practical, logistical, and ethical challenges occur in designing and conducting human trials measuring prevention of drug-induced ototoxicity as well. As noted above, the risks and benefits of research investigations, including clinical trials, must be carefully assessed to assure participants are not exposed to risks outweighing the benefits that might be gained from participation in the drug trial. For patients that are being treated with life-saving therapies, such as cisplatin and aminoglycoside antibiotics, a key concern is that the otoprotective agent must not interfere with the therapeutic mechanism of the cisplatin or the aminoglycoside. If the protective agent were to inadvertently protect the tumor cells, or bacteria, in parallel to the inner ear target, there may be an unacceptable decrease in efficacy of cisplatin or the aminoglycoside antibiotic that prevents the potential otoprotective agent from moving forwards. To resolve concerns regarding drug-drug interactions, studies typically include in vitro cell culture to assess potential compromises in bactericidal or antineoplastic activity, followed by in vivo studies in animal models, before approval to proceed with human investigations is sought. The potential for patient/participant safety issues has slowed the progress of clinical investigations in humans, although data are now beginning to emerge.
Mycophenolate versus Methotrexate in Non-infectious Ocular Inflammatory Disease: A Systematic Review and Meta-Analysis
Published in Ocular Immunology and Inflammation, 2023
Mohammad Karam, Abdulmalik Alsaif, Abdulrahman Al-Naseem, Amrit Hayre, Abdurrahman Al Jabbouri, Ahmed Aldubaikhi, Narvair Kahlar, Salem Al-Mutairi
Two authors independently searched the following electronic databases: MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL). The last search was run on the 20th of May 2021. Thesaurus headings, search operators, and limits in each of the above databases were adapted accordingly to optimise the search results. In addition, World Health Organization International Clinical Trials Registry (http://apps. who.int/trialsearch/), ClinicalTrials.gov (http://clinical- trials.gov/), and ISRCTN Register (http://www.isrctn. com/) were searched for details of ongoing and unpublished studies. No language restrictions were applied in our search strategies. The search terminologies included “methotrexate,” “amethopterin,” “antimetabolite,” “mycophenolate,” “mycophenolic acid,” “uveitis” and “scleritis.” All terms were combined with adjuncts of “and” as well as “or.” To extend the screening for eligible articles, the bibliographic lists of all relevant studies were reviewed.
Fifty years of experience with loxapine for the rapid non-coercive tranquilization of acute behavioral disturbances in schizophrenia patients, and beyond
Published in Expert Review of Neurotherapeutics, 2022
Philippe Nuss, Emmanuelle Corruble, Emmanuelle Baloche, Ricardo P. Garay, Pierre-Michel Llorca
French REALITE surveys [18,19] revealed that loxapine is frequently used as an adjunct in clinical practice to improve clinical efficacy through stabilization of intercurrent disturbances. The pharmacological properties of loxapine are used by clinicians to treat a broad variety of symptoms associated with schizophrenia, including psychotic and affective ones [18,19]. In this context, loxapine is still being investigated regarding its use for the treatment of various symptom fluctuations observed during the schizophrenia course. Recent pharmacological research has revealed unsuspected pharmacological and therapeutic properties [20–25] that could give a rationale for the pragmatic and dimensional use of loxapine. Therefore, we reexamined the literature on loxapine in order to better understand this compound, refine its clinical use, and outline goals for future research. Particular attention was given to (i) early clinical trials demonstrating the antipsychotic efficacy of loxapine oral solution, (ii) more recent clinical trials demonstrating the efficacy of oral and intramuscular formulations of loxapine for the rapid tranquilization of patients suffering from acute psychotic agitation, and (iii) recent biochemical and cellular studies that are defining new avenues of research for future therapeutic targets. A thorough literature review was performed using the following databases: PubMed, Science Direct, Google Scholar, and Cochrane Library. Current clinical trials were searched for on the ClinicalTrials.gov database.
Integrating supportive care into the multidisciplinary management of lung cancer: we can’t wait any longer
Published in Expert Review of Anticancer Therapy, 2022
Alice Avancini, Lorenzo Belluomini, Anita Borsati, Silvia Teresa Riva, Ilaria Trestini, Daniela Tregnago, Alessandra Dodi, Massimo Lanza, Cecilia Pompili, Renzo Mazzarotto, Claudio Micheletto, Massimiliano Motton, Aldo Scarpa, Federico Schena, Michele Milella, Sara Pilotto
Preliminary data suggest that patients evaluated by a multidisciplinary team have more chances to be enrolled in a clinical trial [23] and be referred to palliative care [20,23]. Both these findings have important implications for patients with lung cancer. On one side, participation in clinical trials provides the opportunity to have access to more innovative and potentially less expensive (when medical expenses should be covered by the patient) anticancer treatments [24]. On the other side, a randomized controlled trial has demonstrated that receiving early palliative care was associated with prolonged survival of approximately 2 months and better quality of life in metastatic NSCLC [5,17]. Lastly, multidisciplinary care may reduce the cost associated with lung cancer care. In this sense, Voong et al. have evaluated the impact of multidisciplinary care on healthcare resources in a retrospective cohort of 297 patients with NSCLC. About 46% of patients were seen by specialists within the single-day thoracic oncology multidisciplinary clinic, whereas 54% followed the traditional referral-based thoracic oncology clinics within the same institution [25]. The results highlighted that patients receiving coordinated lung cancer care had fewer visits (4.8 vs. 6.8; p < 0.01) and exhibited a 23% reduction in total charges per patient sustained in the 90 days before treatment compared to patients having a traditional referral-based pathway [25].