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Transforming Lives Through Precision Medicine

In this section you will learn:

From Aug. 1, 2014, to July 31, 2015, the FDA approved nine new therapeutics for treating certain types of cancer, one new cancer prevention vaccine, and one new cancer-screening test.

During the same period, the FDA authorized new uses for six previously approved anticancer therapeutics and one imaging agent.

Pairing the increased understanding of cancer biology with information about each patient’s own cancer is increasing the precision with which radiotherapy and traditional chemotherapy are used.

Clinical trials that aim to match the right therapeutics with the right patients earlier are based on cancer genomics research, and are becoming more common.

Identifying ways to help cancer survivors meet the numerous challenges they face after their initial diagnosis is an area of intensive research.

The dedicated efforts of individuals working throughout the cycle of biomedical research (see Figure 14) have led to extraordinary advances across the continuum of clinical care that are transforming and saving lives in the United States and worldwide.

Biomedical Research
Biomedical research is an iterative cycle, constantly building on prior knowledge, with one discovery influencing the next (see Figure 14). In recent years, the cycle has become increasing efficient as the pace of discoveries has increased, and various sectors within the biomedical research enterprise have become further integrated, leading to one seamless ecosystem (see sidebar on Biomedical Research: What It Is and Who Performs It). As a result of these changes, the pace at which patient lives are transformed through precision medicine has accelerated and will continue to do so for the foreseeable future (see What Progress Does the Future Hold?).

In short, the biomedical research cycle is set in motion when discoveries with the potential to affect the practice of medicine are made by researchers in numerous areas of biomedical research, including laboratory research, population research, clinical research, and clinical practice. Ultimately, the discoveries lead to questions, or hypotheses, that are tested by researchers performing experiments in a wide range of models that mimic what happens in healthy and disease conditions (see sidebar on Research Models). The results from these experiments can lead to the identification of a potential therapeutic target or preventive intervention, or they can feed backward in the cycle by providing new discoveries that lead to more hypotheses.

After identification of a potential therapeutic target, it takes several years of hard work before a candidate therapeutic is developed and ready for testing in clinical trials (see sidebar on Therapeutic Development). During this time, candidate therapeutics are rigorously tested to identify any potential toxicity and to ensure that they have the maximum chance of success in clinical testing.

Clinical trials are a central part of the biomedical research cycle. Before most potential new diagnostic, preventive, or therapeutic products can be approved by the FDA and used as part of patient care, their safety and efficacy must be rigorously tested through clinical trials (see sidebar on What Is the FDA?). There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, and supportive or palliative care trials, each designed to answer different research questions.