Considerations for Conducting Research

January 5, 2015 -- Clinical research studies can provide rewarding opportunities for medical practitioners. Studies allow doctors to provide patients with early access to promising new treatments that may otherwise take years in the United States to obtain approval. Especially in challenging economic times, patients may appreciate the chance to receive compensation and/or discounts on treatment and medications through study participation. In addition, engaging in clinical research can be intellectually stimulating for physicians and staff. Newcomers to clinical research should consider various aspects of research before beginning the study.

Consider Staff Training

Study site personnel must be trained and knowledgeable about good clinical practices, protection of human subjects, confidentiality of protected health information, and U.S. Food and Drug Administration (FDA) regulations. Increasingly, government resources are being devoted to auditing clinical sites, and you, rather than the sponsor, will be held completely responsible for how the study is conducted at your site.

Consider the Criteria

Before agreeing to participate in a study, carefully examine the criteria for study participation specified in the protocol. Sometimes the criteria are extremely restrictive, and it can be frustrating to expend time and effort screening patients only to find a few actually qualify for the study. Make sure that the clinical trial agreement provides reasonable compensation for screening costs. Also, check on whether compensation is included for long-term storage of the copious documents typically generated in the conduct of a clinical study and for the expense incurred if your site is selected for an FDA audit. Clinical trial agreements often fail to recognize these costs, so you may need to specifically ask that they be included.

Consider Patient Expectations

Allocate extra time for counseling potential study participants to ensure patients understand what the study entails so they can provide informed consent. In randomized clinical trials, be prepared to deal with disappointment from patients who are desperately seeking a new treatment if they are randomized to a control group that only receives placebo. You can explain to them that if we were certain that the treatment worked, we wouldn’t need to do the study.

Consider the Impact of Tightening Regulations

The current economic and regulatory environment is creating new challenges for clinical research. On the one hand, we are fortunate to live at a time when so many new ideas exploring how to treat different medical problems are being generated. Each of these new ideas has to be tested in clinical trials to demonstrate safety and efficacy.

On the other hand, the economic collapse last year has made it more difficult for small start-up companies, where many new ideas originate, to obtain the necessary funding to conduct clinical trials. Furthermore, the regulatory hurdles and expense of getting new drugs and devices approved is increasing exponentially. This reduces the incentive for companies to initiate clinical trials unless the medical condition being targeted is relatively common, so that the potential market for the new product will be sufficiently large to recoup the investment.

Consider Outsourcing

Outsourcing, as we have seen in other areas of the economy, is an interesting development in clinical studies. Companies are increasingly recruiting study sites and participants outside of the United States, because more are able to demonstrate the ability to meet strict U.S. standards and are less expensive.

Despite these considerations and the faltering economy, many opportunities to participate in clinical research studies are available. A good way to get started is to make your interest in research known to the medical companies whose products you use regularly. Ask if they are looking for new study sites for their clinical trials. Or suggest a new study idea. If they think it has promise, they can help provide the funding and advice necessary to help you carry it out. Also talk to others who are undertaking research here in Indiana. They may have ideas and considerations to help, too.

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