Recruiting Diabetes Subjects

The disconnect coordinating and connecting interested patients to clinical trials is an ongoing struggle.
Jul 01, 2011

Many patients with a chronic medical condition are interested in finding new and improved treatments for their disease. One method of achieving this is through participation in clinical research. According to a survey of participants,1 two primary reasons patients participate are: potential benefit to themselves or other patients and to enhance knowledge and understanding of their disease.

As researchers work on improving medical treatments for patients, there is often a disconnect coordinating and connecting interested patients to the clinical trials. Understandably, with sponsors spending an average of $7,500 to recruit a single patient for a Phase III clinical trial, linking patients to the correct clinical trial is challenging and expensive. Improved search platforms have been developed that are patient friendly, allowing patients to navigate the complicated and medical terminology laden clinical trial descriptions. These provide search results of trial opportunities that match their medical condition and are close to where they live.

Diabetes mellitus disease

US clinical trials segmented by therapeutic area show metabolic/endocrinology related trials as one of the larger segments being studied. Diabetes is a large component of this segment. In 2011 the estimated prevalence of diabetes was 25.8 million people (8.3%) of the US population.2 Diabetes mellitus is a chronic disease requiring long-term medical care to restrict the development of complications and manage them as they occur. Type 2 diabetes mellitus (T2D) was referred to as adult onset diabetes, typically affecting patients over 40 years old. Because of the epidemic of obesity and the inactivity of children, it is occurring in ever-younger ages. T2D is characterized by peripheral insulin resistance with a varied insulin secretory defect. About 90% of patients who develop T2D are overweight with insulin resistance and lack the ability to increase beta-cell production of insulin. The morbidity and mortality associated with diabetes are related to the short- and long-term complications. These complications include: increased risk of infections, microvascular complications (retinopathy, nephropathy), hypoglycemia and hyperglycemia, macrovascular disease (CAD, stroke), and neuropathic complications. The prevalence of T2D varies widely among various racial and ethnic groups—the fastest growing racial and ethnic groups are Native American and Alaska Native. The risk of retinopathy and nephropathy appears to be highest among blacks, Native Americans, and Hispanics.

Participating in research

Figure 1. Survey takers were asked: Which of the following is the most important reason you might consider participating in a clinical trial?
Many people who take part in studies believe that doing so will benefit themselves and possibly others by increasing life expectancy or reducing suffering now or in the future (Figure 1). The advances in what are known about their disease and medications that they may take now are available only because people before them volunteered to participate in clinical trials. Another reason to consider participation is the access it affords to leading healthcare professionals and potentially useful new therapies that are usually free of charge and are provided under high standards of care.3