To be sure that the potential benefits of a trial are larger than its potential risk, the FDA requires that all trials be supervised by an independent review panel. This review panel, called the Institutional Review Board (IRB), must be composed of representatives from both the medical field and the nonmedical public. Most IRBs include representatives from law, nursing, medicine, and the clergy, as well as researchers who are expert in clinical trials. This group has the job of watching out for the participants’ interests, seeing that scientific standards are upheld, and protecting medical ethics. At periodic intervals during the course of the trial, the IRB reviews the results. Any serious or unexpected toxicity must be reported immediately to both the IRB and the FDA. If the toxicity is serious and is thought to be related to the drug, all participants in the trial must be notified, and the informed consent form must be revised accordingly.      Many trials, and especially those at multiple medical centers dealing with treatments of serious conditions such as HIV infection, are also supervised by a Data Safety Monitoring Board that scrutinizes the data from the trials every six to twelve months. The Data Safety Monitoring Board, made up of experts in the field who are not involved in the trial, is also privy to unblinded results. This board is different from the IRB because it has access to data from all centers participating in the trial, not just the local center. The board’s purpose is to stop the trial as soon as valid results combined from all centers emerge about the drug’s effectiveness or toxicity. Six months into the phase two trials of AZT, the Data Safety Monitoring Board’s review of the unblinded data convinced it to stop the trial and give all participants AZT. One year into the second big AZT trial, the data showed that the drug was beneficial when the CD4 count was below 500, arid that it was less toxic at low doses; the trial was stopped and all participants with low CD4 counts were given low doses of AZT.*188\191\2*

“In many cases fathers are more fortunate than the mothers who are at home because they don’t have to live with the problem twenty-four hours a day. They go to work and have other distractions and other responsibilities. Too frequently the burden (and it can be a burden) falls on the mother, and that’s not fair. One of my jobs is to try to make sure that the father stays involved, that he comes in for the counseling sessions, and that he shares some of the burden. I don’t mean just the physical care of the child. He must shoulder some of the emotional burden, as well. Men often handle grief in a different fashion from women. They can bury themselves in their work and avoid having to face their grief and their emotions. This is less common with women, who seem to take on the responsibility, even when it grinds them down. They have to face the problems hourly, without a refuge. Working women can have an even worse problem. Rather than using work as a refuge, work becomes an additional responsibility. They still have the child and the problem back home. We find that many parents don’t share these problems very well. They need help in communicating with each other, and in learning to share the burdens. It is important to try to keep the lines of communication open between the husband and wife. It is surprising how often they just don’t talk. It is essential that the wife get some relief from her role, even if it is just an hour or two to go out to the market without the child, to go shopping on a Saturday when the husband is off work, to go away for a weekend or to a movie and dinner. A brief respite can make things more tolerable.*233\208\8*

Lipids are measured by analyzing a blood specimen. Eating before the blood test does not affect the level of blood cholesterol. However, it has an effect of the blood triglyceride level. Because both are usually measured from the same specimen, youfor a minimum of 12 hours before your blood is drawn. Do not drink alcohol for a full 24 hours before the test. If you follow these guidelines, your physician will have an accurate measure of your cholesterol, triglycerides, and other blood lipids, rather than depending on unreliable data that merely reflect when and what you last ate.Fasting before a blood test for lipids does not mean that your results will be precisely the same day after day, even if you make no change in your diet, exercise, or medications. Your lipid levels may vary by about 10 percent from day to day. The importance of a blood test for lipids, therefore, is not to detect small changes in results to make a large issue out of whether a particular value is several points “too high.” Rather, it is to establish in a general sense what your risk level is, and to determine whether the response to diet, exercise, or medication is satisfactory.*240\252\8*