Clinical Research Basics

CLINICAL RESEARCH BASICS

Clinical outcomes research provides vitally important information to healthcare providers, patients, payors of healthcare, and policymakers regarding which treatments are helpful, safe, and cost-effective.  Research trials cover a wide range of forms, sizes, scopes and costs.

“Look back” or retrospective studies can be carried out through medical record review or patient questionnaires, phone surveys or other means.  These can provide information on the effects of prior treatments or insight into the natural history of a particular disease.  Prospective, or “forward-looking”, studies gather baseline information, and then additional information at later points, pertaining to the effect of a particular treatment or the natural history of the particular disease.  Various outcomes measurement tools can be used to look at changes over time of pain and functional levels, patient satisfaction, quality of life, and cost-effectiveness.

Research studies can be randomized and controlled through various research protocol designs.  The randomization process is helpful in removing certain population or researcher biases, by ensuring that any particular person in a research study is equally likely to be placed in one arm of the study or another.  This can be randomized to either receiving an active treatment, receiving no treatment, or a placebo treatment.  The no treatment or placebo (fake) treatment group is known as the control group.  These studies are known as randomized controlled trials, or RCTs.  When a treatment group is compared to a non-randomly chosen comparison group, or cohort, this may be referred to as a cohort study.

Clinical trials may also compare two or more different treatments or prevention strategies for a given disease.  This is called comparative effectiveness research (CER). Randomized controlled trials (RCTs) and high quality and well-designed prospective studies provide a high level of evidence that can be used to help with clinical and health policy and payment decision making.