How to Start Doing Office-Based Clinical Trials

Carmen Arismendy, MD


June 09, 2010

In This Article


Physicians in private practice have more opportunities than ever to participate in clinical trials. New viral outbreaks, new allergens, and an increase in diseases associated with an aging population -- such as obesity, cancer, heart disease, and diabetes -- mean that new drugs are needed and being developed.

More than 37,600 new drugs, drug regimens, and devices are being tested in clinical trials. As a highly profitable business strategy and as a helpful patient medical service, doctors can become involved in clinical trials, whether you run a couple of trials within your practice or build a profitable research business.

Clinical research entails a different mind-set from typical patient care. A physician cares for a patient with the desired outcome of cure or improvement; a clinical investigator treats a population with the desired outcome of proving that the drug or device is safe, effective, and fulfills the purpose for which it was created. In research, the hope is that the patient will benefit from trial participation; however, there are no guarantees.

However, to have your trials run smoothly and be rewarding for your business, it's important to avoid some common pitfalls.

How to Become a Research Investigator While Still Running Your Practice

Some physicians mistakenly believe that "my medical assistant can act as the study coordinator," or "I can manage my research and regular practice myself." This is what leads physicians to quit the clinical trials business after their first attempt. Success comes from understanding the scope of the undertaking, and acquiring the training and tools necessary to ensure success.

Regulatory and compliance issues are critically important and are discussed later in this article.

For physicians willing to learn the rules and best practices, the benefits are legion. You create access to new alternative treatments and drugs for patients; you gain medical practice prestige, intellectual stimulation, peer recognition, and a positive revenue stream as well as benefits to the community -- giving access to the uninsured patients and alternative treatment to patients with few options.


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