Almost all of the studies conducted by Aix Scientifics were designed by the company itself or by some of the clinical investigators, always in close cooperation. The direct consequence is the realization of high-quality scientific trials, in which always contemplate the circumstances of clinical practice and formal requirements. These factors ensure a high degree of cooperation and, ultimately, the quality of the data collected in the study.
The criteria for selection of clinical investigators and centers are mainly based on the following: The ability, the number of patients with an indication to study the feasibility and practicality of the centers (availability of equipment and personnel in the office or health center), and the particulars of the promoter, and the international nature of the study.
Throughout the study period, an independent committee will have medical liability that may arise from it, in addition to the center’s researchers. The independent committee (in Europe, “the study advisory committee” in the U.S.: “independent committee monitoring data security”) is required to suspend the examination immediately if, based on the new information discovered, it is questionable continue compensating advantages the risks they take patients.
The site investigator receives a payment enough for the extra work performed and services rendered. In trials of phase I to III, the sponsor usually provides the experimental product without charge. The promoter and all researchers must sign a statement that, apart from this consideration, have not been agreed or undeclared premiums or benefits, to demonstrate that researchers do not have any particular interest in the product.
Clinical studies must be approved by the appropriate ethics committees. However, national laws collect these details.
There are several ways to guarantee the quality of the data collected in the study. The most important is to reduce the number of copies of the hand enrollment data, i.e. the data file transfer from patient to CRD, and then from there to the database. For over ten years Aix Scientifics ® has achieved this goal by creating their own CRD available online. Other common methods are tracking and duplicate data entry. Monitoring is another person to check the accuracy of the data transmitted. Regarding the duplicate data entry, is that two different people enter the same data, a computer program and subsequently compare both sets of data.
Researchers are required to maintain the original records of the patient and study documents for a long period of time, which is agreed in the relevant study protocol. The developer must do the same, so that is maintained for years the possibility to check that the study is correct.
Aix Scientifics, acting as scientific researchers involved in studies from beginning to end scientific assessment of survey data, and writes independently the statistical report. This document is the basic part of the “Clinical Report”, further comprising a medical assessment of the results. Researchers and the developer will have to read and correct the “Clinical Report” and, finally, should affixing its signature.
Researchers, as a group, have the right and, whenever possible, the obligation to publish on their part the main results of the study in a scientific journal. Before presenting the document to the editors, the developer must be able to read the text in order to claim patent rights and correct factual errors, whenever necessary. The promoter has no right to intervene in the study in any other way. To improve the quality of publications, the editors of peer-reviewed journals must have agreed to accept articles from clinical trials whose study has been accepted in a public register before implementation.
Kelly Wilson is a freelance writer. She writes on a variation of topics, regarding this article, she used Clinical Research Organisation websites in order to find out more information about Clinical Project Management.