Ethics clinical trials

The number of partidpants must be chosen so that the trial wUl have suflEdent statistical power , particularly in the case of confirmatory trials. As a general prindple, the greater the number of data, the greater the confidence there is in demonstrating that a statistical difierence between two groups exists, or not. However, numbers of participants will be constrained by cost considerations, the availability of suitable subjects and, above all, by the ethical prindple that subjects should not be enrolled in clinical trial unless they add scientific value. 

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects... 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

When conducting a clinical trial, the well-being of the study subjects is primary. Subjects must be treated fairly and with respect. The two primary methods of ensuring fair treatment of study subjects are review of the study protocol by an Institutional Review Board (IRB) or Ethics Committee and... 

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Regulation of clinical trials through use of a specialized ethics committee at the trial site constitutes a decentralized approach. This approach is used in the Netherlands, where a local medical ethics committee at the site of the trial is responsible for the evaluation. 

In Australia, approval of clinical trials involves both the regulatory authority and an ethics committee. Under the Clinical Trial Exemption (CTX) scheme, a clinical trial proposal must first be evaluated by the TGA, and then approved by an ethics committee on-site. Under the Clinical Trial Notification (CTN) scheme, a trial is evaluated and approved by the local ethics committee, and then notified to the TGA. 

Guidelines V 7 N/A Yes, procedures of committee of medical ethics for clinical trials Yes, set up by the Research Committee of the Ministry of Health V V 9 Yes, norms and regulation of research in clinical pharmacology No, applications are sent to external experts for evaluation... 

NR Cutler, JJ Sramek. Scientific and ethical concerns in clinical trials in Alzheimer s patients the bridging study. Eur J Clin Pharmacol 48 421-428, 1995. 

The review of clinical drug trials by IRBs raises a number of interesting and difficult issues. These relate to the origin and sponsor of the proposed trial, the nature of the institution the IRB serves, and the manner in which the norms for determining ethical conduct in clinical trials can be applied to specific trials. 

Shamoo, A.E. (2000). Future challenges to human subject protection. Scientist, 14 (13) 35, June 26, 2000. www.the-scientist.eom/yr2000/jun/opin 000626.html Sharp, S.M. (2001). The ethical foundations of clinical trials. Appl. Clinical Trials April, 2001, pp. 48-54. 

In most cases, there appears to be no overarching ethical reason to exclude certain subsets of patients from pharmacogenetic-based clinical trials, even those who may be at increased risks of a particular toxicity. However, each situation would need to be considered... 

Since the Kefauver-Harris Amendmenf was adopted in 1962, pharmaceutical manufacturers have been held responsible by the FDA for providing new medications fhaf are bofh safe and effective. In addition to the Kefauver-Harris Amendment, the Belmont Report (written in 1979), established the ethical principles and guidelines for conducting research. The FDA requires that clinical trials be conducted in compliance with a protocol that has been... 

Before a drug is put forward for a clinical trial, there are ethical and regulatory constraints for the design and conduct of a clinical trial that have to be considered. 

Regulatory authorities stipulate the need for ethical principles to be observed when conducting clinical trials. Clinical trials should never be conducted to gain knowledge per se. They should be based on risk-benefit considerations, informed consent, and respect for human individuals. Furthermore, subjects should be protected without being taken advantage of. 

Explain the reasons for ethical considerations before a clinical trial is conducted. 

Due to problems in some early clinical trials, where subjects were taken advantage of, regulatory authorities require that clinical subjects be treated fairly. Ethical considerations should be undertaken to safeguard subjects safety and well-being. 

The regulation of clinical trials is to make certain that first and foremost subjects welfare is not compromised. The need for review and approval by the IRB/IEC provides an independent party to decide the need and procedure contemplated for the clinical trials. The watchdog roles are steps taken to ensure trials are conducted ethically. 

---