florida life sciences blog

4 Ways the FDA Can Improve Clinical Trials for Immune Diseases


Many chronic diseases possess complications that make clinical trials difficult to optimize. For example, immune system diseases can manifest in a variety of ways that vary from patient to patient. These manifestations can even mutate within one individual patient over the course of their treatment, further exacerbating the challenges of treatment and analysis.

To address this problem, clinicians and clinical trial investigators collaborated to review trial data. The following are their solutions to improving the clinical trial process:

  1. Increase collaboration so trials can be available to all relevant patients. Clinical trials have a habit of focusing on majority groups, leaving minorities with limited data for treatments. Many trials underrepresent these minorities, resulting in uneven quality of care.
  2. Reduce the scope of trials. Many trials are large and unwieldy for determining the effectiveness of a placebo versus a new treatment for specific immune diseases. For example, it’s easier to demonstrate the effectiveness of a treatment over a placebo for trials that focus on a specific organ affected by a disease rather than looking at the body as a whole.
  3. Rely on more recent scientific insights to develop trials. Many trials develop around dated beliefs regarding immune diseases. However, recent trials can provide insight to help studies target better candidates to develop superior treatment outcomes. Immune diseases affect certain groups differently than others and it behooves trials to select their candidates accordingly.
  4. Delve into the symptoms before beginning the trial. Immune diseases produce a variety of symptoms that don’t mesh well with the tested treatment. Clinicians need to make sure that an individual’s symptoms are suited to the treatment they are testing before beginning the trial.

These efforts to improve clinical trials for immune diseases are important because current standards of care are falling short for many people suffering from immune diseases. Many suffer through inadequate treatments while experiencing worsening conditions. By trying to optimize the process, clinical trials can produce more effective treatments at a faster rate. To learn how MMA Florida can help your healthcare business with risk assessments and optimization, contact us today.

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