An Overview of Lupus Research: Where We’ve Been and Where We’re Going

Summary of a presentation given at the SLE Workshop at Hospital for Special Surgery Michael D. Lockshin, MD

• What is Clinical Research? • Conducting Clinical Research: Safety and Confidentiality • Treatment Trials • Trial Phases • Kinds of Drugs Observed in Clinical Trials • Aims of Lupus Research • Lupus Clinical Trial Consortium • Tips for Patients/Participants • The Good News • The Bad News/Challenges • Types of Studies at HSS

What is Clinical Research? What is clinical research? “A whole doctor and a whole patient in a room at the same time.” This is very different than looking at tissues in a lab. There are several types of clinical research taking place here at Hospital For Special Surgery. These include: • Treatment trials • Observations to understand the course of disease • Interventions to understand the course of disease • Epidemiology studies that look at how much a population is affected and why • Psychosocial studies • Blood or tissue specimens or autopsiesConducting Clinical Research: Safety and Confidentiality In order to conduct a clinical research study, a series of regulations that is in the interest of patient safety and confidentiality must be followed. For example, a research project must meet Health Insurance Portability and Accountability Act (HIPAA) regulations that guarantee participants’ privacy. The Institutional Review Board (IRB), which is a hospital based entity, has to approve the process of the study as well as the risks and benefits involved and must grant permission to conduct the study in order to ensure the patient’s safety. This process can take about six months or so. In addition to several other regulatory bodies, an outside monitoring board that is not affiliated with the study must monitor the proceedings (Data and Safety Monitoring Board, DSMB). This board can put a stop to the study if they perceive that a participant’s safety and/or privacy are being compromised. A substantial amount of time is invested to ensure that participants are safe throughout the research project and that their confidential health information is not compromised.

Treatment Trials When most people think of clinical research, they usually think of treatment trials. In placebo-controlled studies, treatment is compared to no treatment, and researchers just look to see what happens. These studies usually produce the cleanest and clearest answers. However, an undesirable consequence of this kind of study is that some patients come to realize that they may not receive the treatment under question. More commonly used as a comparison is the standard-therapy controlled approach. In this type of study, a new drug is compared to standard therapy. Although very common and informative, this type of comparison requires more patients to participate than does a placebo-controlled trial because all patients are expected to improve. Lastly, treatment can be compared to how patients did in the past when compared to the new treatment; these comparisons are called historical controls. This involves looking at the history of the treatment of a person over a number of years. This method is not very reliable, however, because the period of time under observation can be influenced by the introduction of other medications in the system, such as antibiotics or blood pressure medications that may also influence a patient’s outcome. … See the complete article on the Hospital for Special Surgery’s web site Summary by Jillian Rose, MSW

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