Clinical Research Personnel

Although clinical researchers conduct the actual research performed in this field, they are supported by biostatisticians, health informatics scientists, pathologists, research nurses and a host of others discussed below.

Clinical Researchers

Clinical research scientists include physicians (M.D.s), who treat patients, (often within the constraints of scientific studies referred to as clinical trials) as well as smaller numbers of PhD's who work entirely in the lab.

Clinical researchers:

Try different combinations and doses of existing drugs to see if they work better than standard treatments (the ones that are already being used to treat patients). Use the information collected from translational research to develop new cancer treatments although sometimes they might use this information to improve standard treatments as well.

• Test new imaging, radiology and surgical techniques using clinical trials in the hope of improving the practice of these specialties.
• Test new psychosocial and prevention strategies

In the United States, the Food and Drug Administration (FDA) must approve new drugs and medical devices (but not dietary supplements) before they can be advertised or sold to the general public. The FDA began overseeing the safety of new treatments in the late 1930s, but didn't require proof of effectiveness until the early 1960s. Today, new drugs and medical devices must go through several phases of clinical trials (discussed further in this chapter) before being approved for use.

Many medicines and drugs work in laboratory tests, but they must be shown to be safe and effective for people before they can be approved by the regulatory authorities and prescribed for patients by doctors.

Clinical research is typically carried out in the hospital setting and usually involves patients in what is known as a clinical trial. Clinical trials show us what works (and what doesn't) in medicine. They are the best way for doctors to learn what is safe and effective in treating cancer.

Biostatisticians

Biostatisticians are statisticians who apply their skills in health-related fields. They typically collaborate with other researchers in the health care field, designing clinical studies, collecting data, and analyzing datasets in pursuit of answers to specific questions.

Such studies may provide information on how a disease progresses, the safety and efficacy of a new treatment or medication, or the impact of risk factors associated with a medical condition. Studies are also conducted to help estimate health care costs and compare quality of health care provided to aid those responsible for making health policy and quality assurance decisions.

Biostatisticians provide expertise in the:

	Planning stages (e.g. experimental design) Sample size considerations Data collection Choosing and implementing appropriate methodologies Interpreting the results of studies.

Sometimes biostatisticians must develop new methods appropriate for analyzing a particular problem. The work of biostatisticians and epidemiologists overlaps considerably, but they are trained to approach problems from different perspectives.

Clinical Research Associates (CRA)

The main function of a clinical research associate (CRA) is to monitor clinical trials. A CRA ensures compliance with the clinical trial protocol (see more about this later), checks clinical site activities, enters data (usually electronically), reviews Case Report Forms (CRFs) (more about this later)) and communicates with clinical research investigators.

A clinical research associate is usually required to have an academic degree in Life Sciences and needs to have familiarity with good clinical practice and local regulations.

		Some CRAs also administer the consent form to patients in a clinical trial ("consenting" the patient). Since data management is the CRAs primary duty, they may not have the required skill set needed to properly consent patients, as this requires good communication skills. Training in good communication skills, however, can help overcome any deficiencies that may exist.