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This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers.
Table of contents
- Practical Guide to Clinical Data Management, Second Edition
- Clinical trial - Wikipedia
- Curtis L. Meinert
In some cases, the male partners of these women are also excluded or required to take birth control measures. Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment s with already approved treatments.
This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for monitoring the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a data monitoring committee DMC, known in the US as a data safety monitoring board. This independent group of clinicians and statisticians meets periodically to review the unblinded data the sponsor has received so far.
The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious adverse events.
The sponsor is responsible for collecting adverse event reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment. The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language.
FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time. The ethical principle of primum non nocere "first, do no harm" guides the trial, and if an investigator believes the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects, and could act unethically to obtain and maintain their participation. The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study.
In other words, they or their legally authorized representatives must give truly informed consent.
Practical Guide to Clinical Data Management, Second Edition
Local investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments. Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events.
When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study.
Approval by an Institutional Review Board IRB , or ethics board, is necessary before all but the most informal research can begin. In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial. However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent s , the data collection forms, and supporting documentation to the local IRB.
Universities and most hospitals have in-house IRBs. Other researchers such as in walk-in clinics use independent IRBs. The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study, before it allows the researcher to begin the study. It may require changes in study procedures or in the explanations given to the patient.
A required yearly "continuing review" report from the investigator updates the IRB on the progress of the study and any new safety information related to the study. In the US, the FDA can audit the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures. This audit may be random, or for cause because the investigator is suspected of fraudulent data. Avoiding an audit is an incentive for investigators to follow study procedures. A 'covered clinical study' refers to a trial submitted to the FDA as part of a marketing application for example, as part of an NDA or k , about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study.
For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as " Alternatively, many American pharmaceutical companies have moved some clinical trials overseas. Benefits of conducting trials abroad include lower costs in some countries and the ability to run larger trials in shorter timeframes, whereas a potential disadvantage exists in lower-quality trial management.
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Beginning in the s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization named after as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH  Currently, most clinical trial programs follow ICH guidelines, aimed at "ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.
These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness. Aggregating safety data across clinical trials during drug development is important because trials are generally designed to focus on determining how well the drug works.
The safety data collected and aggregated across multiple trials as the drug is developed allows the sponsor, investigators and regulatory agencies to monitor the aggregate safety profile of experimental medicines as they're developed. The value of assessing aggregate safety data is: a decisions based on aggregate safety assessment during development of the medicine can be made throughout the medicine's development and b it sets up the sponsor and regulators well for assessing the medicine's safety after the drug is approved.
Clinical trial costs vary depending on trial phase, type of trial, and disease studied. The cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients involved, and whether the study treatment is already approved for medical use. The expenses incurred by a pharmaceutical company in administering a phase 3 or 4 clinical trial may include, among others:. In the US, sponsors may receive a 50 percent tax credit for clinical trials conducted on drugs being developed for the treatment of orphan diseases. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites.
These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them. Using internet resources can, in some cases, reduce the economic burden. Investigators are often compensated for their work in clinical trials.
These amounts can be small, just covering a partial salary for research assistants and the cost of any supplies usually the case with national health agency studies , or be substantial and include 'overhead' that allows the investigator to pay the research staff during times between clinical trials. Participants in phase 1 drug trials do not gain any direct health benefit from taking part. They are generally paid a fee for their time, with payments regulated and not related to any risk involved.
In later phase trials, subjects may not be paid to ensure their motivation for participating with potential for a health benefit or contributing to medical knowledge. Small payments may be made for study-related expenses such as travel or as compensation for their time in providing follow-up information about their health after the trial treatment ends. Phase 0 and phase 1 drug trials seek healthy volunteers. Most other clinical trials seek patients who have a specific disease or medical condition.
The diversity observed in society should be reflected in clinical trials through the appropriate inclusion of ethnic minority populations. All volunteers being considered for a trial are required to undertake a medical screening. Requirements differ according to the trial needs, but typically volunteers would be screened in a medical laboratory for: . It has been observed that participants in clinical trials are disproportionately white. This may reduce the validity of findings in respect of non-white patients.
Depending on the kind of participants required, sponsors of clinical trials, or contract research organizations working on their behalf, try to find sites with qualified personnel as well as access to patients who could participate in the trial. Working with those sites, they may use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go such as doctor's offices , and personal recruitment of patients by investigators.
Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials. For example, the Fox Trial Finder connects Parkinson's disease trials around the world to volunteers who have a specific set of criteria such as location, age, and symptoms. The risk information seeking and processing RISP model analyzes social implications that affect attitudes and decision making pertaining to clinical trials. Cancer patients reported more optimistic attitudes towards clinical trials than the general population.
Having a more optimistic outlook on clinical trials also leads to greater likelihood of enrolling. From Wikipedia, the free encyclopedia. For the journal, see Clinical Trials journal. Main article: Phases of clinical research. Main article: Clinical study design. Main article: Clinical trial protocol. This section does not cite any sources. Please help improve this section by adding citations to reliable sources. Unsourced material may be challenged and removed. November Learn how and when to remove this template message. Main article: Placebo-controlled studies.
Main articles: Clinical research ethics and Clinical trials publication. Bill and Melinda Gates Foundation. Retrieved 1 January Journal of Health Economics. The New York Times. Of the drugs started in clinical trials on humans, only 10 percent secure F. Powerful Medicines , pp.
Alfred A. US Food and Drug Administration. Retrieved 2 October Annals of Surgery. World Journal of Methodology. Clinical trials: design, conduct, and analysis. The Harvard Medical School guide to men's health. New York: Free Press. New York, NY: St. Martin's Press. Diffusion of Innovations. Page 7. Retrieved 9 September Clinical Trials in Oncology, Second Edition. CRC Press. Clinical Trials Handbook.
Educational research: Planning, conducting, and evaluating quantitative and qualitative research 3rd. Retrieved 27 October Journal of Medical Biography. Retrieved 24 May Pharm Med. Archived from the original on 7 July Retrieved 5 January Retrieved 4 January Archived from the original on 14 March Basic Books. Cardiovascular Interventions.
Anesthesia and Analgesia. Retrieved 14 November Archived from the original on 10 April American Society of Clinical Oncology. Annual Meeting. Clinics in Dermatology. Pharm-Olam International. Archived from the original PDF on 15 July Retrieved 26 April Archived from the original on 4 February Retrieved 20 May Medical Law International. Redefining the relationships between doctors and drug companies.
British Medical Journal. Archived from the original PDF on 25 June Retrieved 2 June Retrieved 22 May Current Medical Research and Opinion. Annals of Internal Medicine. Food and Drug Administration. June Retrieved 16 October Retrieved 9 August PLoS Medicine. Common Dreams. Center for Drug Evaluation and Research. Retrieved 11 November December Clinical Trials. Retrieved 27 March Journal of Medical Internet Research. Archived from the original on 14 November A review of trials funded by two UK funding agencies". Boston, MA: CenterWatch.
Retrieved 26 November Financial Times. Retrieved 26 February Fox Trial Finder. Archived from the original on 3 October Journal of Health Communication. Finn R Henninger D In Henderson DR ed. Concise Encyclopedia of Economics 1st ed. Library of Economics and Liberty. Clinical Trials: A Practical Approach.
Pharmacology 5 ed. Edinburgh: Churchill Livingstone. Clinical research and experimental design. Clinical trial Trial protocols Adaptive clinical trial Academic clinical trials Clinical study design. Randomized controlled trial Scientific experiment Blind experiment Open-label trial. Cross-sectional study vs. Incidence , Cumulative incidence , Prevalence , Point prevalence , Period prevalence. Risk difference , Number needed to treat , Number needed to harm , Risk ratio , Relative risk reduction , Odds ratio , Hazard ratio. Attributable fraction among the exposed , Attributable fraction for the population , Preventable fraction among the unexposed , Preventable fraction for the population.
Clinical endpoint , Virulence , Infectivity , Mortality rate , Morbidity , Case fatality rate , Specificity and sensitivity , Likelihood-ratios , Pre- and post-test probability. Risk—benefit ratio Systematic review Replication Meta-analysis Intention-to-treat analysis.
Selection bias Survivorship bias Correlation does not imply causation Null result. Category Glossary List of topics. Product testing. Standards organization Consumer organization Trade organization Food safety organization.
Clinical trial - Wikipedia
Conformance testing Chemical test Destructive testing Discrimination testing Nondestructive testing Physical test Sensory analysis Survey research Test method Usability testing. Outline Index. Descriptive statistics. Mean arithmetic geometric harmonic Median Mode.
Central limit theorem Moments Skewness Kurtosis L-moments. Index of dispersion. Grouped data Frequency distribution Contingency table.
Pearson product-moment correlation Rank correlation Spearman's rho Kendall's tau Partial correlation Scatter plot. Data collection. Sampling stratified cluster Standard error Opinion poll Questionnaire. Scientific control Randomized experiment Randomized controlled trial Random assignment Blocking Interaction Factorial experiment. Adaptive clinical trial Up-and-Down Designs Stochastic approximation.
Curtis L. Meinert
Cross-sectional study Cohort study Natural experiment Quasi-experiment. Statistical inference. Z -test normal Student's t -test F -test. Bayesian probability prior posterior Credible interval Bayes factor Bayesian estimator Maximum posterior estimator. Correlation Regression analysis. Pearson product-moment Partial correlation Confounding variable Coefficient of determination. Simple linear regression Ordinary least squares General linear model Bayesian regression. Regression Manova Principal components Canonical correlation Discriminant analysis Cluster analysis Classification Structural equation model Factor analysis Multivariate distributions Elliptical distributions Normal.
Spectral density estimation Fourier analysis Wavelet Whittle likelihood. Daniels; W. See Chapter 7 on Clinical Trials. Introduction: A clinical trial is a prospective research study conducted in humans to assess the impact of an experimental intervention. The intervention can be a drug product, a device such as a surgical stent or diagnostic tool, a procedure such as a surgical treatment, or a behavioral intervention. Clinical trials are a critical step to therapeutic development because they provide the necessary methodology to make inferences with minimal bias and the best possible precision.
Clinical trials have been in existence since the s, although the primary concepts and terminology of trials were not identified until much later, and clinical trial methods and regulations continue to be developed. Even as the U. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations.
Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April This publication summarizes the presentations and discussions from the workshop.
Meinert Call Number: Online. First published in , this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials.
It contains a wealth of practicalinformation on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail on such issues as sample size calculation, stratification and randomization, data systems design, development of consent forms, publication policies,preparation of funding requests, and reporting procedures.
While the basics of design, conduct, and analysis of clinical trials remain the same, there have been significant changes since the first edition of Clinical Trials was published two decades ago. In this new edition, the author discusses the refinements and improvements made to methods andprocedures, changes in the policies and guidelines underlying trials, as well as requirements for registration of trials. He also discusses current practices for data sharing, for gender representation, for treatment effects monitoring, and for ethical standards of clinical trials.
The importance ofthe randomized controlled trial has grown significantly over time and they are now the cornerstone of all evidence-based medicine. Still rich in tables, checklists, charts, and other resources for the trialist, the second edition of Clinical Trials is an indispensable reference for clinicians,biostaticians, epidemiologists, and anyone involved in the design and implementation of a clinical trial.
Naidu; P. Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinicalfocuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training.
The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.