Clinical trials application procedure

Information in regulatory files (e.g., clinical trial applications). Existing literature and current compliance guidelines and procedures. Feedback on early phase methods. 

The principles of the Directive should remove the complexity of clinical trial application, authorization and regulation in existing, new, and future Member States. Thus, substantial amendments to protocol that impact on safety of the subjects or where there is a change in the interpretation of data on the IMP must be notified under the legislation underpinning the Directive. This common process will obviate current disparate national procedures that range from a simple notification scheme to a complex authorization proce-dure. Implementation of the Directive cannot be expected to alter national requirements for provision to examiners of Information to Subjects and Informed Consent forms in local languages. 

If the results of the in vitro tests are satisfactory, then in vivo tests in small animal models such as mice, rats, guinea pigs or rabbits are performed at different durations with a statistically significant number of animals, including controls. If these results are satisfactory, then the device is tested in large animal models relevant to the application, such as pigs or sheep. Finally, the device is tested in clinical trials. Different procedures for all these tests have been described and normalised. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

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... 

Research in the field of ultrasound contrast materials will develop in two basic directions - the simple and the complex . The simple would mean wider clinical application of the store of available (or to-be-approved) contrast agents in clinical diagnostics. The success will depend not only on the quality of the new diagnostic procedures and results of the clinical trials with new ultrasound... 

The LA had 35 days to respond to the notification to proceed with a clinical trial but could in exceptional circumstances require a further 28 days to consider the notification, if the CTX was refused, the applicant could apply for a CTC, in which case complete data had to be filed, if the CTC application was refused the statutory appeal procedures came into play if the applicant company wished to avail itself of this provision. These appeal procedures were identical with those applying to marketing applications. The CTX scheme proved highly successful in encouraging inward investment into research in the United Kingdom, in a sample of 42 companies, an increase in research investment of 10% or more was attributed to the scheme by 23 of them. its implementation was criticised by consumer groups and its effect was carefully monitored every 6 months to ensure that no added risk to patients had been introduced. 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

For each clinical trial contributing to a marketing application, all important details of its design and conduct and the principle features of its proposed analysis should be clearly specified in a protocol written before the trial begins. The extent to which the procedures in... 

HPLC is a complex analytical methodology that involves the development of a unique method for each new application. This method development often requires the optimisation of several method conditions to achieve a desired selectivity and sensitivity [12,13]. HPLC is also one of the most commonly applied analytical techniques and is in widespread use throughout the pharmaceutical industry for applications as diverse as quality control, stability studies and clinical trials. These two reasons mean that HPLC has been the focus of most research into ruggedness testing procedures because it is most likely to require extensive ruggedness... 

The key elements of an inspection are to ensure that the facility is capable of fulfilling the application commitments to manufacture, process, control, package, and label a drug product following GMP the adequacy and accuracy of analytical methods submitted, to ensure that these methods are proper for the testing proposed correlation between the manufacturing process for clinical trial material, bioavailability study material, and stability studies and submitted process that the scientific data support full-scale production procedures and controls that only factual data have been submitted and that the protocols are in place to validate the manufacturing process. 

As mentioned earlier, the expectation of the FDA is not only that the applicable regulations from 21CFRwill be complied with during the course of clinical trials, but also that pharmaceutical companies will develop adequate written policies and procedures to describe how the conduct their clinical research processes in compliance with the regulations. Table 2 provides a list of some procedures that Parts 50,56, and 312 require in writing. 

Platelet glycoprotein Ilb/llla (GPIIb/llla) receptor inhibitors are widely used to prevent thrombotic vascular events, especially in patients with acute coronary syndromes (ACS) or in those undergoing intravascular interventional procedures. The purpose of this chapter is to evaluate the quality and magnitude of the clinical trial evidence in support of their use, In addition, key issues regarding their optimal application in clinical practice will be discussed. 

Before a new pharmaceutical product can be tested in clinical trials, the test product, its labelling and the intended trials must be approved. This is usually done by the same authority that is responsible for the market approval of the final product. The formal procedures to obtain permission for clinical trials vary. Some countries require only a notification to the authority, which may then object within a certified period, other countries require a formal application in order to obtain approval, e.g. by issuing a Clinical Trial Certificate (CTC), before the trials can commence. 

In the EEC, applications or notifications for clinical trials have to be lodged with the individual national authorities. A common procedure or even mutual recognition of clinical trial certificates does not exist. A list of the different national requirements is provided in "The Rules Governing Medicinal Products in the European Communities" Volume III, Annex 1. A discussion paper (III/ 3044/91) released in 1991 by the EEC Division for Pharmaceuticals (DG III) addresses various issues on the harmonization of approval of clinical trials and may eventually lead to common, non-binding recommendations. 

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