Clinical Protocols risks

For women who are of childbearing potential, the risks can be evaluated in reproductive toxicology studies and steps taken to minimize those risks. Alternatively, stringent contraceptive requirements can be incorporated into the clinical protocol to prevent the occurrence of pregnancy in the participants, although in practice, contraception is usually specified in all cases. Any risks should be... 

Clinical protocols and investigator information—detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators—professionals (generally physicians) who oversee the administration of the experimental compound—to assess whether they are qualified to fulfill their clinical trial duties finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an IRB, and to adhere to the IND regulations. 

Clinical protocols are designed to maximize the amount of data that can be obtained in a particular study while minimizing the risk to the subject. The situation is complicated since our major interests are the investigation of calcium kinetics in children. The protocol must be designed to be benign yet give the required kinetic dat Because the subjects are minors informed parental consent must be obtained in addition to the assent of the subject. 

Clinical Review. The reviewing medical officer, who is generally a physician, evaluates the clinical protocols to ensure (1) that subjects will not be exposed to unreasonable or unnecessary risks during clinical triads and (2) that Phase 2 and Phase 3 trials (generally not submitted in the initial IND filing) are adequate in design to provide scientifically valid data. 

As with the imposition of a clinical hold, FDA can halt further use or distribution of an investigational drug through withdrawal or suspension of an IND. Similar concerns, such as undue patient risk or serious deficiencies in the application or the clinical protocol, trigger both types of agency action, with withdrawal obviously reserved for the more serious cases. 

Prior to the initiation of initial studies in humans, it is important that all of the nonclinical information available is made into an integrated summary. This information must be included in the clinical investigators brochure so that the clinical protocol can be modified to include relevant biochemical or other markers to minimize human risk. The regulatory authority and ethics committees are... 

The a priori identification of specific risk hypotheses leads to the ability to take some of the methodology normally applied to hypothesis testing of efficacy results and apply it to safety assessment. The most important difference between these two analysis domains is that in the case of efficacy, outcomes of interest are identified a priori with great specificity, and clear statistical hypotheses are laid out in advance with complete analysis and decision rules documented in the clinical protocol. In practice, only a few efficacy variables are identified as primary, and only a few others as second-ary. Sensitivity, statistical power, and sample size are all carefully analyzed in advance to assure the trial will have a high probability of detecting differences of interest in these few critical variables. 

Based on the currently available data, three conclusions can be drawn (1) time from symptom onset remains critical in cases of IV thrombolysis, (2) better patient selection and triage criteria can be used to reduce risk, increase efficacy, and expand the therapeutic window, and (3) centers must develop an organized response to acute ischemic stroke with clinical protocols and quality of care assessment tools. 

The clinical protocol determines whether the protocol will expose subjects to unnecessary risks. The protocol contains the qualifications and credentials of the investigator(s). The protocols are very detailed including the qualifications of all professionals administering the nonapproved drug product. Protocols for each phase of clinical study are required. All human research subjects must be informed of all the risks and benefits of the drug product. Informed consent must be obtained from all subjects prior to enrollment in the clinical trial. 

Other findings indicate that many researchers and organizations failed to comply with clinical protocols for carefully assessing and selecting patients for the trials and for monitoring them thereafter. Additionally, it was found that many doctors had failed to fully inform prospective patients of uncertainties about the benefits and risks of the therapies or other relevant information (e.g., that other enrolled patients and test animals had suffered adverse events). Thus, doctors had enrolled patients without their informed consent to medical experimentation in violation of clinical protocols and medical ethics. 

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

Luster, M.I., et al., Associating changes in the immune system with clinical diseases for interpretation in risk assessment, in Current Protocols in Toxicology, Maines, M. et al., Eds., John Wiley and Sons, Hoboken, 2005, chap. 18. 

Name and description of the clinical trial protocol Summary of results from nonclinical studies Potential risks and benefits to human subjects Description and justification for route of administration, dosage, and treatment plan Compliance to GCP... 

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