Reach Out to the People - Applied Clinical Trials

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Reach Out to the PeopleWho better to educate a wary public about clinical research than the industry's own?

Source: Applied Clinical Trials




In recent years, the public's perception of the clinical research industry has eroded to an all-time low. Media coverage of study mishaps combined with the rising cost of prescription drugs have contributed to the growing mistrust between the public and industry.

A survey conducted by the Kaiser Family Foundation back in 1997 found that 79% of individuals felt drug companies did a "good job" of serving the public. The same survey conducted in 2004 found that a majority of Americans felt for the first time that drug companies did a "bad job" of serving their customers.1 This change demonstrates that the clinical research industry needs to re-establish its credibility to regain public confidence.

Clinicians as educators

Clinical research is a fundamental process that is necessary to bring safe and effective new drugs to the market for public use. Surveys show that 83% of individuals agree that it is either "essential" or "very important" to test new drugs on humans before they are approved for general use.

Although the majority of respondents strongly believe that clinical trials are valuable, only 32% feel that participants receive good medical care, and only 13% believe that participants will not suffer more pain or side effects than if they received standard treatment. In addition, only one in four people indicated they are very confident that "new treatments are tested in clinical trials only after there is good scientific evidence that the treatments are likely to be effective and safe,"2 and 62% believe that pharma companies manipulate clinical data.3

The perceptions and attitudes of individuals who have participated in clinical research studies are drastically different from the general public's: 90% rate the quality of care they received during a clinical trial as "excellent,"4 and 84% indicate they would participate in another clinical study if given the chance.5 This difference in attitude between the general public and those who have actually participated in research indicates a significant gap between what the general public perceives and the positive experiences of research volunteers.

In order to regain public confidence, clinicians and industry leaders need to alter their current patterns of industry promotion and media response. They need to become more active in broad-based advocacy and outreach programs, proactively promote the clinical research industry within the health care community, and improve media relations. These changes will help educate the public about the clinical research process by giving them a more complete understanding of the quality of care subjects receive and how they can find research opportunities and information on clinical research studies for which they may be eligible.

Public perception impact

The cost of trials is rising exponentially. In 1997, it was estimated that the cost to bring a new drug to market was $800 million; costs have soared to nearly $1.5 billion today.6 Contributing to rising costs are the longer development timelines required to bring a new drug to market. The average clinical phase time for new biopharmaceuticals increased from less than three years in the 1980s to between six and seven years today, while total R&D spending rose from $21 billion in 1998 to more than $51 billion in 2005.7,8,9

As mentioned, an increasing number of individuals are growing skeptical of the personal benefits and safety of clinical studies. Of the 50,000 trials taking place in the United States, 80% are delayed at least one month due to unmet enrollment projections.10 This lack of subject participation stems from a variety of sources, including negative media coverage, poor public perception, and a lack of education. Only one in four people feel that trial patients receive honest and accurate information and are not treated like "guinea pigs."11

The abundance of information indicating public trust has rapidly declined in recent years helps identify why many clinical studies fail to meet enrollment projections. Robert Kelch of the University of Iowa College of Medicine credits two reasons for why this lack of trust has occurred: insufficient clinical advances compared to public expectations, and social and business trends that have changed the public's perception of health care from a social good to a purchasable commodity.


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