Recruiting Diabetes Subjects

July 1, 2011
Ryan Luce

,
Neil Warnock, MD

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2011, Volume 20, Issue 7

The disconnect coordinating and connecting interested patients to clinical trials is an ongoing struggle.

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

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

Figure 1. Survey takers were asked: Which of the following is the most important reason you might consider participating in a clinical trial?

Survey of diabetes patients

In a recent survey, 355 patients with diabetes were asked about their background, income level, medication use, clinical trial involvement, overall experience, and reasons for participating in clinical research (the demographics of respondents are provided in the online version of this article).

Noteworthy survey findings include: 57% of patients had not previously participated in a clinical trial, of those patients, 55% had never really considered nor talked with their doctor about clinical trial participation.

Of the patients that had participated in a clinical trial, there was a wide range of times since they had first enrolled in a clinical trial (less than six months to more than 10 years). When asked about their experience in clinical trials, 88% rated their experience as positive to very positive and 88% would recommend clinical trial participation to other patients with diabetes. Additionally, 88% of patients indicated that it was likely or highly likely they would consider participating in another clinical trial.

How do patients find trials?

Pew Research reported that 80% of online Americans search for health information on the Internet and an overwhelming majority of patients (75%) feel reassured or empowered with the ability to search and satisfy their information needs.4

A common site when beginning an Internet-based search is http://clinicaltrials.gov. Since 2008, it has been required by law that all clinical trials in the United States are listed on the http://clinicaltrials.gov website. While it is comprehensive, it is heavy in medical jargon and does not have some of the key functionality needed for helping educate patients.

The search process for clinical trials is a barrier, even for motivated patients. When considering how patients learn about clinical trials and gain access, Internet-based searches are the obvious starting point, and often the primary source for consumer health information. Simon and Hegedus, examined website content that provided details about cancer clinical trials using popular search engines.5

Of the 66 sites they reviewed, many provided detailed information about cancer clinical trials and about half offered some form of clinical trial search function. Their conclusion was that clinical trial websites provide benefits, including access to information about clinical trials and links to clinical trial search tools. Unfortunately, however, the amount and diversity of this information, the difficulty of the language used, and the potential lack of confidentiality may all be barriers to a patient finding the right trial.

As patients search for clinical trials, only 14% obtain information from their physicians whereas 44% find out about clinical trials through media. Another small percentage of patients are referred to clinical research by family members or friends. Researchers and sponsors are using the power of the Internet to help people identify and enroll in studies. In a recent NIH study, content analysis revealed that clinical content is highly variable on these sites.6

Most require users to be fairly knowledgeable about their medical condition and quite adept in their web navigation skills. In order to identify a potential trial, patients must comprehend the medical terminology related to their condition and understand the potential treatment or intervention. This is combined with a need to understand the general clinical trial research process while learning the demands of a specific trial to determine their interest and eligibility.

Often patients begin their search for clinical trial information on familiar sites, such as YouTube and Google, where site navigation is familiar and straightforward. Other websites' (i.e., http://WebMD.com, http://MedlinePlus.gov) health discussion forums are emerging sources to obtain general health information.

The more sophisticated patients may search the NIH website or go directly to a pharmaceutical company's site known for producing their medication. Social media and blogs are rapidly becoming popular sources for clinical trial information. For example, research sites and academic medical centers are beginning to use Facebook links to their trials.

Optimized search tools

To optimize success in identifying a clinical trial that a patient is qualified to enroll in, a search tool needs to provide a comprehensive listing of all clinical trials without complex medical jargon and provide some basic patient educational information in a user-friendly format.

Conclusion

The clinical trial search process by and recruitment for patients needs to be continuously updated and improved. In addition to gaining input from patients to simplify and enhance their search options, developers should share these tools with healthcare providers and their staff to integrate patient recruitment into the clinical encounter.

Neil Warnock,* MD, MBA, MS, is CMO at Corengi, e-mail: nwarnock@gmail.com and Ryan Luce, PhD, is President at Corengi, 7054 Mary Ave. NW, Seattle, WA.

*To whom all correspondence should be addressed.

References

1. D. Wendler, B. Krohmal, E. J. Emanuel, and C. Grady, "Why Patients Continue to Participate in Clinical Research," Arch Intern Med, 168 (12) 1294-1299 (2008;).

2. National Diabetes Information Clearinghouse, "National Diabetes Statistics, 2007," http://diabetes.niddk.nih.gov/DM/PUBS/statistics/.

3. The Center For Information & Study on Clinical Research Participation, "Clinical Trial Facts & Figures for Health Professionals," http://ciscrp.org/professional/facts.html

4. S. Fox, "Online Health Search 2006," Pew Internet & American Life Project, http://www.pewinternet.org/Reports/2006/Online-Health-Search-2006.

5. C. Simon and S. Hegedus, "Exploring Websites on Cancer Clinical Trials: An Empirical Review," Contemporary Clinical Trials, 26 (5) 530-533 (2005).

6. N. L. Atkinson, S. L. Saperstein, H. A. Massett, C. R. Leonard, L. Grama, and R. Manrow, "Using the Internet to Search for Cancer Clinical Trials: A Comparative Audit of Clinical Trial Search Tools," Contemporary Clinical Trials, 29 (4) 555-564 (2008).

Survey Demographics

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