The Importance of a Representative Patient Population for Research

Over the past 4 years, the SolveCFS BioBank™ has become a sought after resource for ME/CFS research. Ten of the brightest investigators from the best medical institutions have used the samples and information from the SolveCFS BioBank™ to conduct research in the following areas:PatientCentered

  •  case definition
  • patient-reported outcomes
  • autoimmunity
  • viral pathogens
  • epigenetics
  • immune function
  • biomarker validation

Importantly, 8 of these 10 researchers are new to ME/CFS research, most of them recruited to the field by our organization.  And ours is an illness which NEEDS more researchers…and much more research.

 

Why did we create the SolveCFS BioBank™?

The Solve ME/CFS Initiative recognized that in order to recruit the best and brightest into ME/CFS research, the researchers would need access to ME/CFS patients and controls. If we could offer researchers access to the right type of biological specimens for their experiment – access to ME/CFS patients with demographic and clinical characteristics that represent the full range of people affected with ME/CFS – it would remove one of the hurdles all researchers face. By creating a biobank, we realized that we could make ME/CFS research more appealing and/or accessible.

 

What is the ideal representation of patients and controls in any biobank?

An ideal biobank contains patients that reflect the population of all those affected by a disease.  We know that certain diseases can occur more frequently in women, children, or a specific race. There are some diseases in which what is truly a representative patient population is not known, either because population-based epidemiology studies have not been done or because many groups are historically underrepresented in medical research (e.g., because of race/ethnicity, access to care, socioeconomic status, gender, severity of illness).

Fortunately, this is not the case with ME/CFS. There have been several epidemiology studies that have clearly demonstrated that ME/CFS does not discriminate. Community-based research has shown that ME/CFS can strike anyone.  For example, Dr. Leonard Jason of DePaul University found that in Chicago, ME/CFS occurred at higher rates in women, Latinos, middle-aged individuals and people of middle to lower socioeconomic status.[1] Centers for Disease Control and Prevention (CDC) found that even in their epidemiology study with 86% Caucasian participants, rates of ME/CFS were higher in the non-white study participants.[2] The CDC also found the rate of ME/CFS in men and women varied depending on whether one lived in a major metropolitan area or a rural area.[3] There are many more epidemiology studies on ME/CFS. While none are without flaws, these studies clearly indicate that ME/CFS affects individuals of all ages, genders and race.

representative_crowdLooking forward to our goal – a treatment approved by the FDA – it is important that studies are done using a representative patient population. Therefore, it is important that researchers have access to representative patient populations so that their results can be generalized to the affected population as a whole.  For example, if research is only done on women, then these results may not be relevant to men.  This is not to say that research cannot ask specific questions about ME/CFS in women, for example, but the limitations of studying only women must be made clear.  And access to a representative patient population provides researchers the opportunity to conduct very specific research on sub-groups AND research that can be generalized to the population as a whole.

 

As a national organization, reaching patients online rather than in a clinic in a specific location, we have the unique and important ability to reach a broad, diverse population of patients.  Over the past year our SolveCFS BioBank™ has grown to 1,000 strong.  Patients, family members and friends have signed up to participate in research that will help us Solve ME/CFS.

BioBank participants have recently begun receiving survey requests that will help us begin to determine how representative our SolveCFS BioBank™ is at this time.  If we find that some patient groups are underrepresented, we will reach out to these groups to increase their enrollment. Earlier this year, SMCI was fortunate to have received from Google access to $10,000 per month in in-kind online advertising support through a program called AdWords. With this tool, we look forward to reaching even more patients and controls to further strengthening our BioBank… and in turn, strengthening our offering to the research community to further progress.

 

Read more about the future of the Solve CFS BioBank™ in this prior post: SolveCFS BioBank™: Then, Now & the Next Evolution

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big-donate-modifiedThe Solve ME/CFS Initiative is targeting our work in order to one day understand ME/CFS at an unprecedented molecular level and be able to guide research and development of new diagnostic tests and better treatments. Your support and participation has gotten us this far and it is critical to the path forward. Please consider a gift that is meaningful to you – any and every donation helps fuel the path forward.

Tags: , , , , , , , , , , November 18, 2014
  • Firestormm

    How do you ensure a diagnosis of ME/CFS is vlaid when asking for/collecting samples i.e. who determines diagnosis and how is this determined?

    Many thanks

  • Nancy Selissen VandenPlas

    If you need more subjects. PLEASE choose me…I will try anything!! Thank you, Nancy