Artykuły w czasopismach: „Clinical trials”

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Santhosh R Divya, Samuel. "In Silico Clinical Trials - Review". International Journal of Science and Research (IJSR) 12, nr 6 (5.06.2023): 262–66. http://dx.doi.org/10.21275/sr23512133636.

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Vulto, Arnold G. "Clinical trials on trial". European Journal of Hospital Pharmacy 19, nr 4 (sierpień 2012): 347. http://dx.doi.org/10.1136/ejhpharm-2012-000180.

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Dmitrienko, Alex, Gautier Paux i Thomas Brechenmacher. "POWER CALCULATIONS IN CLINICAL TRIALS WITH COMPLEX CLINICAL OBJECTIVES". Journal of the Japanese Society of Computational Statistics 28, nr 1 (2015): 15–50. http://dx.doi.org/10.5183/jjscs.1411001_213.

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Seow, Hsien-Yeang, Patrick Whelan, Mark N. Levine, Kathryn Cowan, Barbara Lysakowski, Brenda Kowaleski, Anne Snider, Rebecca Y. Xu i Andrew Arnold. "Funding Oncology Clinical Trials: Are Cooperative Group Trials Sustainable?" Journal of Clinical Oncology 30, nr 13 (1.05.2012): 1456–61. http://dx.doi.org/10.1200/jco.2011.37.2698.

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Purpose Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. Methods We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Results Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an “l” shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). Conclusion The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.

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Hamm, Caroline M., Krista Naccarato, Stephen Sundquist, Suzana Kovacevic, Youshaa El-Abed i Janet Dancey. "Clinical trials navigator: Patient-centered access to clinical trials." Journal of Clinical Oncology 38, nr 15_suppl (20.05.2020): e14024-e14024. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e14024.

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e14024 Background: Despite recommendations from premier institutions such as NCCN that all cancer patients should be entered on clinical trials, only 3 – 5 % of adult cancer patients are enrolled on clinical trials in North America. The reason for this is multi-factorial and includes poor trial design, inappropriate endpoints, inappropriate inclusion/exclusion factors, attitudes about trial participation held by patient and/or treating physician and lack of trial availability. Methods: To address issues of trial availability, in March 2019, we initiated a novel service to help Canadian patients find clinical trial options. The service compares patient demographic and health status information provided against potential opportunities sourced using clinicaltrials.gov and Canadian clinical trials websites. A report presenting outcomes of CTN review is developed for the requesting patient or physician. An interview is provided for the self-referring patient by supporting physicians. Results: To date 96 patients have used this service. Most (94%) were stage IV or refractory/ relapsed. Smaller disease sites represented 23% of our patient population (brain, sarcoma, pancreas). Our turn-around-time from request of services to delivery of report to patient or physician improved over time and is currently 24 hours during the working week. Of those eligible, 25% of patients died before referral, the median time from referral to the CTN to the patient’s death was 109 days (3 – 188 days). Conclusions: Significant interest from both physicians and patients for this service was identified. Strategies are being developed to encourage earlier referrals to clinical trials would improve number of patients entering clinical trials as 25% of our patients. [Table: see text]

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Harman, Chloë. "Putting clinical trials on trial". Nature Reviews Nephrology 5, nr 6 (czerwiec 2009): 301. http://dx.doi.org/10.1038/nrneph.2009.89.

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Levine, Deborah J., i Fernando Torres. "Clinical Trials Update". Advances in Pulmonary Hypertension 12, nr 2 (1.01.2013): 53–54. http://dx.doi.org/10.21693/1933-088x-12.2.53.

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The Clinical Trials Update highlights new and ongoing research trials that are evaluating therapies for PAH. In this issue, Deborah Levine, MD, examines the PATENT-1 study results, findings from CHEST-1, and outcomes of the SERAPHIN trial.

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Gnanasambandam, Anjali. "Artificial Intelligence in Clinical Trials- Future Prospectives". Bioequivalence & Bioavailability International Journal 7, nr 1 (4.01.2023): 1–8. http://dx.doi.org/10.23880/beba-16000196.

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Clinical trials are essential for delivering novel medications, technology, and procedures to the market and clinical practice. Only 10% of these studies complete the entire procedure from the drug design to the four phases of development, because clinical trials are becoming more expensive and difficult to perform. The population's health, standard treatment, health economics, and sustainability suffered greatly from this low completion rate. Artificial intelligence (AI) is one of the tools that could streamline some of the processes which are the most tedious operations, like patient selection, matching, and enrollment; better patient selection could also minimize harmful treatment and its side effects. The widespread implementation of AI technology in clinical trials still faces many challenges and requires more high-quality prospective clinical validation. In this review, we discussed the prospective applications of AI in clinical research and patient care in the future

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Bousquet, Philippe Jean, Pascal Demoly, Giovanni Passalacqua, G. Walter Canonica i Jean Bousquet. "Immunotherapy: clinical trials – optimal trial and clinical outcomes". Current Opinion in Allergy and Clinical Immunology 7, nr 6 (grudzień 2007): 561–66. http://dx.doi.org/10.1097/aci.0b013e3282f1d6a4.

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Singh, Jerome Amir. "Adaptive clinical trials in public health emergency contexts: ethics considerations". Wellcome Open Research 8 (23.03.2023): 130. http://dx.doi.org/10.12688/wellcomeopenres.19057.1.

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While Adaptive Clinical Trials (ACTs) have grown in prevalence, prominence, and impact, the ethical issues implicit in such trial designs, particularly in the context of public health emergencies, have been afforded relatively scant attention. This work argues that the ethical dimensions of ACTs should be considered at trial conception, factored into the trial’s design, and subject to ongoing evaluation during the trial’s conduct.

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Kim, Edward S., Dax Kurbegov, Patricia A. Hurley i David Michael Waterhouse. "Barriers to clinical trial accrual: Clinical trialists' perspectives." Journal of Clinical Oncology 37, nr 15_suppl (20.05.2019): e18156-e18156. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e18156.

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e18156 Background: Oncology clinical trial participation rates remain at historic lows. There are many barriers that impede participation. Understanding those barriers, from the perspective of cancer clinical trialists, will help develop solutions to increase physician and site engagement, with the goal of improving accrual rates and advancing cancer treatment. Methods: Physician investigators and research staff from community-based and academic-based research sites were surveyed during ASCO’s Research Community Forum (RCF) Annual Meeting (N = 159) and through a pre-meeting survey (N = 124) in 2018. Findings and potential solutions were discussed during the meeting. Results: 84% of respondents (n = 84) reported that it took 6-8 months to open a trial and 86% (n = 81) reported that trials had unnecessary delays 70% of the time. The top 10 barriers to accrual identified were: insufficient staffing resources, restrictive eligibility criteria, physician buy-in, site access to trials, burdensome regulatory requirements, difficulty identifying patients, lack of suitable trials, sponsor and contract research organization requirements, patient barriers, and site cost-benefit. Respondents shared strategies to address these barriers. Conclusions: The current state of conducting clinical trials is not sustainable and hinders clinical trial participation. New strategies are needed to ensure patients and practices have access to trials, standardize and streamline processes, reduce inefficiencies, simplify trial activation, reduce regulatory burden, provide sufficient compensation to sites, engage the community and patients, educate the public, and increase collaborations. The ASCO RCF offers resources, available to the public, that offer practical strategies to overcome barriers to clinical trial accrual and has ongoing efforts to facilitate oncology practice participation in clinical trials.

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Raya-Ampil, Encarnita, i Jeffrey L. Cummings. "Clinical Trials in Dementia". Progress in Neurotherapeutics and Neuropsychopharmacology 2, nr 1 (13.06.2006): 39–78. http://dx.doi.org/10.1017/s174823210600005x.

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ABSTRACTDementia, particularly Alzheimer's disease (AD), is increasing by patient population included in clinical trials. The methodology for trials of AD patients have been defined in terms of outcomes, standard measures and analytic techniques. Trial methodology is evolving with experience as new potential therapies become available. Screening criteria, instrumentation choices, duration of trials and analytic strategies may have a profound impact on the conclusions that can be derived from trials. The components of AD trials are reviewed in detail in this chapter.

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MN, Khan. "The Role of Pharmacovigilance in Investigational New Drug (IND) Clinical Trials". Advances in Pharmacology and Clinical Trials 9, nr 1 (23.01.2024): 1–6. http://dx.doi.org/10.23880/apct-16000233.

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The total number of clinical trials registered so far across India was 63,174. Clinical trials from India accounted for only 8.7% of the total number of trials conducted, while clinical trials from the US accounted for 47% of the total number of trials registered, followed by 24% from the EU and 13.1% from Japan. We can increase the number of clinical trials by ensuring the role of pharmacovigilance in investigational new drug (IND) clinical trials in ensuring safety, efficacy and ethical conduct of pharmaceutical research. As pharmaceutical companies advance novel compounds through clinical development, pharmacovigilance serves as a comprehensive system for the detection, assessment, and mitigation of potential risks associated with investigational drugs. This perspective review explores the multifaceted role of pharmacovigilance in IND clinical trials, emphasizing its significance in safeguarding trial participants and contributing to the overall success of drug development programs. Underscores the critical role of pharmacovigilance in investigational new drug clinical trials From pre-trial planning to post-marketing surveillance, pharmacovigilance is integral in maintaining the safety, integrity, and ethical conduct of clinical research. As an essential component of the drug development process, pharmacovigilance contributes to the overarching goal of delivering safe and efficacious treatments to patients and can be increase the clinical trial participation globally

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Nakamura, Kenichi. "EL2 CHANGES IN JAPANESE ACADEMIC CLINICAL TRIALS AND FRAMEWORKS FOR PLANNING CLINICAL TRIALS". Neuro-Oncology Advances 1, Supplement_2 (grudzień 2019): ii4. http://dx.doi.org/10.1093/noajnl/vdz039.018.

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Abstract After the enforcement of the Japanese Clinical Trials Act, the number of investigator-initiated registration-directed trials (IIRDT, Chiken) is increasing while the number of non-registration academic trials is decreasing. Pharmaceutical companies tend to make an investment in IIRDT because the data derived from IIRDT can be utilized for new drug application for PMDA, which means the goals and return are clear for industries. On the other hand, the reason of the decrease of non-registration academic trials is the burden of cost and procedures specified in the Clinical Trials Act. In order to start academic trials, certain amount of research budget is indispensable due to the cost for certified review board and clinical trial insurance. Also, even minor changes of site information in jRCT should be submitted to certified review board and the hospital directors of all participating sites, which is one of the most serious burden for investigators. Confirmation of COI declaration in participating sites is another burden for investigators/sites. Under these circumstances, the number of non-registration academic trials will be decreasing for the time being. In the Clinical Trials Act era, investigators must prepare some budget to start clinical trials. In order to obtain public funding, social/scientific value and scientific validity are substantially important. To express the social value sufficiently, the purpose of the trial should focus not on the researcher’s interest but on the contribution for patients. In terms of scientific validity, the framework of PICO is useful; PICO means Patient, Intervention, Control and Outcome. Utilization of this framework and the consistency of these four factors are essential to make the trial design sound.

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Mugosa, Snezana, i Anja Glusica. "Clinical trials challenges - impact of the new clinical trial regulation on the conduct of clinical trials". Vojnosanitetski pregled, nr 00 (2021): 61. http://dx.doi.org/10.2298/vsp200316061m.

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Weinberg, Jeffrey. "Clinical Trials in Progress: ROADS Trial". ONCOLOGY, nr 3508 (sierpień 2021): 495. http://dx.doi.org/10.46883/onc.2021.3508.0495.

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Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with GammaTile for Treatment of Newly Diagnosed Metastatic Brain Tumors (ROADS; NCT04365374).

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Dean, Rachel S. "Veterinary clinical trials are on trial". Veterinary Record 181, nr 8 (18.08.2017): 193–94. http://dx.doi.org/10.1136/vr.j3867.

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Mockus, Susan M., Sara E. Patterson, Cara Statz, Carol J. Bult i Gregory J. Tsongalis. "Clinical Trials in Precision Oncology". Clinical Chemistry 62, nr 3 (1.03.2016): 442–48. http://dx.doi.org/10.1373/clinchem.2015.247437.

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Abstract BACKGROUND Availability of genomic information used in the management of cancer treatment has outpaced both regulatory and reimbursement efforts. Many types of clinical trials are underway to validate the utility of emerging genome-based biomarkers for diagnostic, prognostic, and predictive applications. Clinical trials are a key source of evidence required for US Food and Drug Administration approval of therapies and companion diagnostics and for establishing the acceptance criteria for reimbursement. CONTENT Determining the eligibility of patients for molecular-based clinical trials and the interpretation of data emerging from clinical trials is significantly hampered by 2 primary factors: the lack of specific reporting standards for biomarkers in clinical trials and the lack of adherence to official gene and variant naming standards. Clinical trial registries need specifics on the mutation required for enrollment as opposed to allowing a generic mutation entry such as, “EGFR mutation.” The use of clinical trials data in bioinformatics analysis and reporting is also gated by the lack of robust, state of the art programmatic access support. An initiative is needed to develop community standards for clinical trial descriptions and outcome reporting that are modeled after similar efforts in the genomics research community. SUMMARY Systematic implementation of reporting standards is needed to insure consistency and specificity of biomarker data, which will in turn enable better comparison and assessment of clinical trial outcomes across multiple studies. Reporting standards will facilitate improved identification of relevant clinical trials, aggregation and comparison of information across independent trials, and programmatic access to clinical trials databases.

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Pineda, Jaime Algorta, Ana Belén González Hernández, María Teresa González Martel, Clara Vivanco Tesos i Carlos Corral Corral. "Clinical trials". Pharmaceuticals, Policy and Law 17, nr 1,2 (2015): 117–52. http://dx.doi.org/10.3233/ppl-140405.

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Page, Suzanne. "Clinical trials". Morecambe Bay Medical Journal 2, nr 7 (2.01.1996): 214–16. http://dx.doi.org/10.48037/mbmj.v2i7.1007.

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Giacinti, Laura. "Clinical trials". Frontiers in Bioscience 11, nr 1 (2006): 2918. http://dx.doi.org/10.2741/2020.

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Badiu, C. "Clinical Trials". Acta Endocrinologica (Bucharest) 9, nr 3 (2013): 439–44. http://dx.doi.org/10.4183/aeb.2013.439.

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Palmer, N., i E. Kay. "Clinical trials". British Dental Journal 198, nr 6 (marzec 2005): 350. http://dx.doi.org/10.1038/sj.bdj.4812226.

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Hogan, Michelle. "Clinical Trials". Oncology Times 29, nr 10 (maj 2007): 63–64. http://dx.doi.org/10.1097/01.cot.0000282483.02437.74.

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Shapiro, David. "Clinical trials". Nature 379, nr 6564 (luty 1996): 393. http://dx.doi.org/10.1038/379393c0.

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Steiner, Jan, i June Grindley. "Clinical trials". Nature Biotechnology 12, nr 12 (grudzień 1994): 1313. http://dx.doi.org/10.1038/nbt1294-1313b.

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&NA;. "Clinical trials". Current Opinion in Cardiology 13, nr 5 (wrzesień 1998): B203—B205. http://dx.doi.org/10.1097/00001573-199809000-00012.

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Chaitman, Bernard R. "Clinical trials". Current Opinion in Cardiology 15, nr 4 (lipiec 2000): 273–74. http://dx.doi.org/10.1097/00001573-200007000-00011.

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Boden, William E. "Clinical trials". Current Opinion in Cardiology 16, nr 6 (listopad 2001): 361–63. http://dx.doi.org/10.1097/00001573-200111000-00008.

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Cleophas, Ton J. M. "CLINICAL TRIALS". American Journal of Therapeutics 3, nr 7 (lipiec 1996): 529–34. http://dx.doi.org/10.1097/00045391-199607000-00010.

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Lindsey, Jane. "Clinical Trials". Journal of the American Statistical Association 98, nr 463 (wrzesień 2003): 774. http://dx.doi.org/10.1198/jasa.2003.s299.

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Minneci, Peter C., i Katherine J. Deans. "Clinical trials". Seminars in Pediatric Surgery 27, nr 6 (grudzień 2018): 332–37. http://dx.doi.org/10.1053/j.sempedsurg.2018.10.003.

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Stutzer-Treimel, Karen. "Clinical Trials". AACN Advanced Critical Care 19, nr 2 (kwiecień 2008): 130–33. http://dx.doi.org/10.1097/01.aacn.0000318114.36567.5f.

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Donnan, Geoffrey A., Stephen M. Davis i Donald A. Berry. "Clinical Trials". Stroke 36, nr 7 (lipiec 2005): 1621–22. http://dx.doi.org/10.1161/01.str.0000170637.02692.14.

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Lomberk, Gwen. "Clinical Trials". Pancreatology 6, nr 6 (styczeń 2006): 510–11. http://dx.doi.org/10.1159/000096124.

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Heskett, Karen. "Clinical Trials". Journal of Consumer Health On the Internet 8, nr 3 (23.09.2004): 35–52. http://dx.doi.org/10.1300/j381v08n03_03.

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&NA;. "Clinical trials". Inpharma Weekly &NA;, nr 818 (grudzień 1991): 5. http://dx.doi.org/10.2165/00128413-199108180-00014.

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&NA;. "CLINICAL TRIALS". ASAIO Journal 42, nr 2 (kwiecień 1996): 54–55. http://dx.doi.org/10.1097/00002480-199642020-00010.

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Young, Robert C. "Clinical Trials". Oncology Times 30, nr 9 (maj 2008): 3–4. http://dx.doi.org/10.1097/01.cot.0000319868.25639.1d.

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Verdolini, Katherine. "Clinical Trials". Perspectives on Voice and Voice Disorders 8, nr 1 (kwiecień 1998): 17. http://dx.doi.org/10.1044/vvd8.1.17.

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Cleophas, Ton J. "Clinical Trials". American Journal of Therapeutics 22, nr 1 (2015): e1-e5. http://dx.doi.org/10.1097/mjt.0b013e31824c3ee1.

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Cleophas, Ton J. "Clinical Trials". American Journal of Therapeutics 23, nr 3 (2016): e844-e849. http://dx.doi.org/10.1097/mjt.0b013e318250f779.

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Harms, Michele. "Clinical Trials". Physiotherapy 84, nr 2 (luty 1998): 104. http://dx.doi.org/10.1016/s0031-9406(05)66564-9.

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Ellenberg, Jonas H. "Clinical Trials". Neurologic Clinics 8, nr 1 (luty 1990): 15–30. http://dx.doi.org/10.1016/s0733-8619(18)30371-2.

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Parish, Lawrence Charles, Joseph A. Witkowski i Larry E. Millikan. "Clinical Trials". International Journal of Dermatology 25, nr 5 (czerwiec 1986): 300–301. http://dx.doi.org/10.1111/j.1365-4362.1986.tb02248.x.

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SCHNEIDER, IRIS J. "Clinical trials". Nature 347, nr 6292 (październik 1990): 418. http://dx.doi.org/10.1038/347418c0.

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Ndwandwe, Duduzile, Sinazo Runeyi, Lindi Mathebula i Charles Wiysonge. "Rotavirus vaccine clinical trials: a cross-sectional analysis of clinical trials registries". Trials 23, nr 1 (17.11.2022). http://dx.doi.org/10.1186/s13063-022-06878-6.

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Abstract Background Rotavirus is a primary infectious virus causing childhood diarrhoea and is associated with significant mortality in children. Three African countries (Nigeria, the Democratic Republic of Congo, and Angola) are among the five countries that account for 50% of all diarrheal-related deaths worldwide. This indicates that much needs to be done to reduce this burden. The World Health Organization International Clinical Trial Registry Platform (WHO ICTRP) is a global repository for primary registries reporting on clinical trials. This study aimed to identify and describe planned, ongoing, and completed rotavirus vaccine trials conducted globally. Methods We searched WHO-ICTRP on 17 June 2021 and conducted a cross-sectional analysis of rotavirus studies listed in the database. Data extraction included trial location, participant age, source of the trial record, trial phase, sponsor, and availability of results. We used the Microsoft Excel 365 package to generate descriptive summary statistics. Results We identified 242 rotavirus vaccine trials registered from 2004 to 2020. Most of these trials were registered retrospectively, with only 26% of the rotavirus vaccine trials reporting the availability of results in their registries. Most of the trials are studying children aged less than 5 years. The recruitment status for these trials is currently shown in the WHO-ICTRP as “not recruiting” for 80.17% of trials, “recruiting” for 11.57% of trials recruiting, and unknown for 6.61% of trials. The continents in which these rotavirus vaccine trials have recruitment sites in Asia (41%) and North America (20%), with the maximum number of trials in the clinical trial registries coming from India (21%) and the USA (11%) with most being sponsored by the pharmaceutical industry. Our analysis shows that only 26% of the rotavirus vaccine trials report the availability of results in their registries. Conclusions Mapping rotavirus vaccine clinical trial activity using data from the WHO ICTRP beneficial provides valuable information on planned, ongoing, or completed trials for researchers, funders, and healthcare decision-makers. Despite the high rotavirus disease burden in low- and middle-income countries, including Africa, there is minimal clinical trial activity related to the condition on the continent. The clinical trial registries as a valuable tool to share interim results of the trials.

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Jakkula, Shirisha, Pravalika Pasupuleti, Mujeebuddin C.S, Ravindra Pratap Gaur i Sujay S. Patil. "Clinical trials tranformation intiative-decentralized clinical trials: a review article". World Journal of Current Medical and Pharmaceutical Research, 4.10.2021, 107–15. http://dx.doi.org/10.37022/wjcmpr.v3i5.190.

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In clinical research, Decentralized clinical trials (DCTs) can provide opportunities to maximize efficiencies. Unlike the traditional clinical trial model, Decentralized Clinical Trials (DCTs) promote telemedicine, mobile/local healthcare providers (HCPs), mobile/web-based technology, and direct distribution of Investigational Medicinal Products (IMP) to patients, among other things. Hence, DCTs are in the spotlight as technology, infrastructure, and knowledge providing a backbone in clinical research. Background: Advances in electronic communication, data storage, emerging technologies, and biosensor development provides new opportunities to exchange information, such as the patient is tested from their home locations and are with locations distant from the investigator. Trials that take place at locations distant from the investigator (i.e., spectrum: CCTs → Hybrid Models → DCTs) in any or all study-related procedures and data is collected electronically fall in the category of the decentralized clinical trial. Trials should be designed to integrate the current healthcare system of the study subject, optimize convenience for study subjects and take advantage of existing programs and data sources including The study subjects themselves through the utilization of telecommunication, videoconferences, mobile or internet-based tools for patient reporting, mobile technology tools and biosensors. Local healthcare providers, home-based healthcare services, pharmacies, clinics, regional hospitals, their perceived obstacles have impeded the widespread use of mobile devices in clinical trials. To encourage solutions to these challenges, The Clinical Trial Transformation Initiative (CTTI) has released best practices and practical methods to advance solutions to these issues that clinical trial sponsors can now use. Conclusion: Decentralized clinical trials are not only operationally feasible and show high recruitment rates, have better compliance, lower dropout rates, and are conducted faster. DCT meets the goal of the industry in being low-risk, high returns trials and can offer a reliable, time-based, and cost-effective approach.

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"Clinical Trials Update". Advances in Pulmonary Hypertension 10, nr 1 (1.01.2011): 60–61. http://dx.doi.org/10.21693/1933-088x-10.1.60.

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The Clinical Trials Update highlights new and ongoing research trials that are evaluating therapies for pulmonary arterial hypertension. In this issue, Deborah Jo Levine, MD, describes a recent trial of sildenafil.

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Cornely, Oliver A., i Cara Lange. "Clinical Trials". VacciTUTOR, 8.11.2021. http://dx.doi.org/10.33442/vt202114.

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Clinical trials (a.k.a. clinical studies) in vaccinology are investigations with humans to assess the immunogenicity, reactogenicity i.e., the expected local or systemic symptoms of the desired immune response, safety and/or efficacy or effectiveness of vaccines. Such investigations must be designed, conducted, and analysed based on scientific principles to get sound answers to specific questions stated in the trial plan. Since Clinical Trials involve human subjects, highest ethical standards need to be applied. In addition, national laws, licensing regulations and international standards, for example Declaration of Helsinki, regulate the procedures and conduct of clinical trials. Vaccine trials can be classified by development phase (phase I-III before licensure; phase IV post-licensure); by purpose; or role of the investigator. The study protocol covers design, selection of study subjects, selection of endpoints, methods to minimize bias, conduct of the study and analysis plan, all aimed at answering the study question with best possible internal scientific validity.

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