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Still On Trial

Clinical trials – most of them, anyway – are not likely to inspire an episode of CSI or Law and Order: UK.  Research studies are not often  particularly glamorous or provocative.  They do have all sorts of interesting rules and regulations, however, and despite what is being researched, a lot of studies share many activities in common:

  • Participants may be asked to perform certain tasks between appointments or check-ups, including taking medication according to a very particular schedule, completing logs or diaries and answering questionnaires.
  • The health of participants will be checked by the research team at the start of the trial and will be monitored thereafter at regular intervals.
  • Participants will be given specific requirements and instructions for participating.
Clinical trials are conducted in all sorts of settings, depending on what is being investigated.  The use of specialized equipment may involve a clinic or other health care setting while studying the effects of vitamins or herbs may see the participants following a schedule from home.  In some cases where a specific therapy is part of the study, trial participants may go to a hospital, clinic or research center for treatment and evaluation.
Once the trial is completed, the researchers analyze the data collected from the study and consider what the results might mean.  Participants will be told about the study findings or results soon after the study is completed and the data evaluated.  These results might also be shared with the medical community and then the public.  The media may cover the findings.  Trial results are usually reported in a peer-reviewed medical journal and discussed at scientific gatherings.  ‘Peer-reviewed’ means that a report is read and reviewed prior to publication by experts in the same field.
CAM clinical trials present some interesting challenges.  Many traditional treatments have been used for years, even centuries, but there is little by way of science, at least in Western terms, to explain their efficacy or real or potential benefits.  Without science, there may be more risk than practitioners and patients understand.  Researchers today are studying CAM treatments in clinical trials to answer questions such as:
  • Does the treatment work?
  • If yes, how exactly does it work?
  • What dose or schedule is safe?
  • For which diseases, illnesses or conditions does it work?
  • What dose or application is effective for a particular disease or condition?
  • What are the side effects or adverse effects?
  • How should the treatment be given?
  • When is the treatment harmful?
  • Can it be used safely with other treatments?
  • Compared with other options available, is it better or useful?
If you are considering becoming part of a clinical trial, think about the following:
Benefits:
  • You may help others by participating.
  • You may have the opportunity to receive expert medical care while you are part of a study.
  • You may be among the first to benefit from a new treatment or from new knowledge about an existing therapy.
  • Some clinical trails offer a chance to receive excellent treatment or prevention of an illness or condition.
Risks:
  • The treatment or therapy may have adverse effects that were not anticipated by the researchers setting up the trial, or the effects may be very different from what they expected.
  • The treatment being studies may not be better than the standard therapy, or may even be worse.  
  • If you are part of a randomized study, you may not be assigned the treatment you were hoping for.  And you generally do not know which group you are in.
  • The treatment many simply not work for everyone – you included.
  • Participation may see you subjected to more tests, treatments and office or clinic visits than with conventional or regular care.
  • There may be some costs to take part, costs that may not all be covered by health insurance.  Be sure to ask the researchers setting up the study about any costs involved.
ClinicalTrials.gov is a database of thousands of clinical trials being sponsored by NIH, other Federal agencies and the pharmaceutical industry.  The NCCAM Clearinghouse is another really useful site.  The more you know, especially from thoughtful and thorough sources, the better. 
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