Clinical trials process

Table 4.4 The clinical trial process. A drug must satisfactorily complete each phase before it enters the next phase. Note that the average duration listed here relates mainly to traditional chemical-based drugs. For biopharmaceuticals, the cumulative duration of all clinical trials is, on average, under 4 years...

Institutional Review Boards (IRBs) in the Clinical Trial Process... 

The sponsor bears ultimate responsibility for the success, failure, and safety of the treatment under study, even after FDA approval. In addition, the sponsor is the true innovator in the clinical trial process. Innovation is expensive, causing newly available treatments to be costly to the end user. Thus, because of e escalating price of medications, the innovators are under increased scrutiny by consumers and polic5mrakers. Paradoxically, as the population ages, the consumers are driving the demand for new cures and better treatments. 

The clinical trial process prescribed by these guidelines is the subject of Chapter 7. 

Both the EMEA and the EDA have recognised the need to streamline the drug development process in order to bring new medicines to patients more rapidly see for example FDA (2004) Critical Path Initiative . The FDA raise (FDA (2006) Critical Path Opportunities List ) a number of statistical issues that need to be resolved in order to help make the clinical trials process more efficient ... 

Prior to phase I clinical trials, process steps and assays that relate to safety should be validated. For example, sterility assays and sterilization processes must be validated. Cell lines should be qualified prior to any clinical trials, including testing for adventitious agents and identifying and quantifying indigenous virus. Virus clearance steps should be validated, and removal of any potentially toxic or otherwise harmful agents should be validated [41,42],... 

It is clear that the quality assurance organization plays a central role in coordinating facilitating, and documenting the formal investigation of an OOS result, whether the affected batch is utilized prior to approval (i.e., clinical trials, process validation) or postapproval as marketed product. 

Building quality throughout all aspects of the clinical trial process and installing QA oversight early on will not only serve to assure the integrity of the study, but will most certainly support the compliance requirements set forth by FDA. 

The effect of this reversal of the trend toward individualization is likely to increase burdens on the clinical trial process and on the submissions of NDAs and ANDAs. If customization is not practical through physician-patient trial and error experimentation, the submission of clinical data that defines effects and side effects specific to interactive medical conditions, ethnicity, gender, age, and genetic characteristics becomes all the more important. Unless a developer is willing to settle for a high-restricted label, significantly expanded and targeted clinical trials are the most likely response to the need for customized medication. 

The formulation, manufacturing process, analytical development, and long-term toxicology studies in animals are parallel to the clinical investigation (Table 1.1). Clinical trial materials should be developed, manufactured, tested, and released before conducting a phase I clinical trial. Process chemists may redesign the synthetic route for the dmg candidate to meet the requirements of large-scale production in a pilot plant. Preformulation scientists complete the activities of salt selection,... 

At any time in the clinical trials process, the FDA is allowed to issue a clinical hold if it is deemed necessary. A clinical hold is an order to the sponsor to delay a proposed investigation or to suspend an ongoing investigation entirely. When a clinical hold is issued, no new subjects are allowed to enter the program, and patients already in the study must be taken off the drug unless discontinuing the treatment could interfere with patient safety. During the period from 1999 to 2001, the FDA... 

The DCO is the point person for daily clinical operations. He is the individual who interfaces with sponsors, investigators, study coordinators and other professional staff on a regular basis to oversee clinical and budgetary status of ongoing and upcoming studies. Because of the intense, close attention to detail that the job demands, it makes sense to fill this position with a highly detail-oriented individual with an understanding of the clinical trials process. 

To offer sponsors, investigators, and patients a guaranteed quality in the clinical trial process, by executing a correct reception, storage, and dispensation of the investigational drug. 

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