Clinical trials study centres

Another trick was to publish only some of the data from a clinical trial, a manoeuvre that researchers call cherry-picking the data. Some clinical trials are conducted in more than one location. These are called multi-centre studies. Multi-centre studies make it easier to find sufficient patients to conduct the trial. They also make it easier to cherry-pick the data. For example, one multi-centre study of Prozac was presented to the FDA as showing a drug-placebo difference of three points on the Hamilton scale. When data from this clinical trial was published, the difference was reported as 15 points - a five-times increase in effectiveness. How was this magical augmentation of the benefits of Prozac accomplished The full study was conducted on 245 patients. The published paper reported data from only 27 of these patients. In the published version, the data from the bulk of the patients were left out, making the drug seem much more effective than it really was. 

This section aims to provide sufficient information for the pharmaceutical physician to effectively prepare and support a clinical trial. However, clinical trials come in many forms and what is appropriate for a single-centre non-sponsored trial is totally inappropriate for a multicentre global study sponsored by a big pharmaceutical company or institution. Similarly, a Phase 1 non-patient volunteer study... 

This term is generally used to denote the administration file kept for each trial and each investigation centre. Box 7.1 lists some of the documents that need to be present before a clinical trial starts. (See ICH GCP Chapter 8 for the full list.) Once the study has started, other documents will be added, including completed CREs, ICFs and subjects medical records and other documents directly involved in the study. Some documents have to be kept specifically at the sponsor s office or the controlling centre. Separate files will contain financial and budget-related documents. 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

Currently, the agency recommends sponsors to recruit more than 10 patients at each centre, and most of the study centres are able to accommodate this number. As the overall number of clinical trials has declined because of the new GCP guidelines and unfavourable pricing rules for the new products, with limited advantage over existing products, it has become relatively easy for the sponsors to meet such requirements than before. 

The new GCP guidelines has expanded the IRB constitution and its role in the clinical trial. The IRB must consist of more than five members and must include non-medical personnel and a person who does not relate to the study centre. There are no requirements regarding the balance of gender. The head of the institute can attend the IRB meetings but cannot be a member nor discuss or vote at the meeting. 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

Gordon Rewcastle obtained his PhD in Organic Chemistry from the University of Auckland in 1978, and after post-doctoral study in the U.S., he joined the Auckland Cancer Society s Research Laboratory as a medicinal chemist in 1980. Since then has participated in a number of antibacterial and anticancer drug development projects, and is the author or co-author of over 100 scientific papers and patents in the anticancer area. In all, he has made significant contributions to the development of six of the eight anticancer drugs to have gone to clinical trial from the Auckland Cancer Centre. 

In summary, this novel approach to substituted titanocene dichlorides delivered compounds with a cytotoxic activity in the range of 240-32 pM, which represents an up to 60-fold increase in cytotoxicity compared with the unsubstituted Cp2TiCl2. The major advantage of diaryhnethyl-functionalised titanocenes is the absence of stereo centres, and with further improvements, there are potential candidates for pre-clinical studies with potential for clinical trials. 

The purpose of a clinical trial is to improve our knowledge of treatments in order that future patients may benefit. The patients actually recruited on a clinical trial have not presented for this reason, however. They expect their physician to treat them with the best treatment available, although they may, of course, be prepared to make some sacrifice in the interest of others. (In the case of chronic diseases there is also the possibility that they themselves may be numbered among the future beneficiaries.) On the other hand, to make wise choices as to treatment, one has to know something about the alternatives and this means that to get precise information about the value of a given treatment, one will also have to study other treatments which may turn out to be inferior. Furthermore, because patients vary over time and from centre to centre and because physicians and facilities vary also, in order to deal with these sorts of bias the ideal solution will be to study patients under various alternatives concurrently. There is thus a dilemma facing the physician in a clinical trial how does the physician as scientist satisfy the physician as healer and vice versa ... 

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