Investigational drugs

Definition

Investigational drugs is the term that refers to drugs that have received FDA approval for human testing, including those drugs still undergoing clinical trials , but are not approved for marketing to the general public.

Description

Investigational drugs represent interesting and novel new agents in the fight against cancer. These agents include chemotherapy designed to treat specific cancers, to provide palliative therapy for pain and symptoms, and to reduce invasive cancers in high-risk patients. The challenge faced by private and commercial investigators is to reduce the lag time in bringing an investigational drug to market without compromising drug quality or patient safety. The guidelines that insure the correct procedures are being followed in the process of drug development and approval fall under the direction of the Food and Drug Administration (FDA).

At present, the cycle of investigational drug research and development, to clinical trials, to FDA approval can easily cover a period of 10-12 years. Under exceptional circumstances, provisions can be made for patient use of investigational drugs under the guidance of specially trained and registered oncologists. These specific investigational drugs are classified as "Group C" drugs, and have demonstrated a high level of reproducible activity in pre-clinical testing. There is also the route of "Accelerated FDA Approval" for some investigational drugs. Accelerated approval relies on specific indicators that suggest that a particular investigational drug is likely to have beneficial effects before the benefits have been clinically verified. All investigational drugs that have been granted accelerated approval must undergo follow-up testing in order to receive final FDA approval. Some researchers are presently working on a format to combine traditional clinical testing of investigational drugs with a global database of drug information. This integrated system would give FDA monitoring agencies and healthcare providers access to the most comprehensive source of archived data available on investigational drugs. This combined approach is another attempt to reduce approval time for investigational drugs and make these agents available to the cancer patient for treatment.

Resources

PERIODICALS

Chopra, Ian. "Research and development of antibacterial agents." Current Opinions in Microbiology 1998 (1):495-501.

Johnson, Dale E. and Grushenka H.I. Wolfgang. "Predicting human safety: screening and computational approaches." Drug Discovery Today 5:10 (October 2000): 445-454

OTHER

Preclinical Development of Investigational Agents: The Developmental Therapeutics Program CTEP Feb. 2001 Info CTEP. 08 May 2001 <http://www.CTEP.info.nih.gov>

Understanding the Approval Process for New Cancer Drugs. Understanding Trials. July 1999 NCI Cancer Trials.18 May 2001 <http://www.cancertrials.nci.nih.gov>

Jane Taylor-Jones, Research Associate, M.S.

KEY TERMS

Oncologist

—A physician who specializes in the diagnosis and treatment of cancer patients.

Palliative

—Therapy or medication designed to provide relief but does not affect a cure for the condition.