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Why Clinical Trials?

07/07/2015

Clinical trials are the fastest, most impactful gateway to effective therapies. They are used to test the safety and effectiveness of drugs and devices in humans and are the critical step between the laboratory and commercial availability of a drug therapy. Support of a drug in clinical trials has a higher probability of success, and a shorter potential lead time to a cure or therapy, as compared to funding of earlier stage research.

Despite this, there is specifically a lack of clinical trial funding outside NIH and traditional industry channels.

Through funding a clinical trial, individuals will be able to see near-term tangible impact from their contribution in the form of a specific clinical trial with open, and published results.


BASIC QUESTIONS ABOUT CLINICAL TRIALS


WHAT ARE CLINICAL TRIALS?

Clinical trials are research studies to explore whether a treatment is safe and effective for humans, and may show which approaches work best for certain illnesses or groups of people. They are one of the last stages in the drug development process.

Clinical trials are used to study:

  • Prevention options
  • New treatments
  • New ways to use existing treatments
  • New diagnostic or screening techniques
  • Comparison of existing treatments
  • Quality of Life trials that explore ways to improve comfort and quality of life for those with a chronic illness
  • The studies are regulated by the Food and Drug Administration (FDA) and conducted according to a protocol that describes what types of patients may enroll, exact tests and procedures, drugs, dosages, length of study, and study endpoints. 


WHERE ARE CLINICAL TRIALS CONDUCTED?

Clinical trials are sponsored by an organization (e.g. a pharmaceutical company, a non-profit), a federal agency (e.g. National Institutes of Health), or an individual (e.g. a researcher or health care provider). The sponsor determines where the trials are conducted, and these are usually at universities, medical centers, clinics, hospitals, and designated research sites.


ARE CLINICAL TRIALS SAFE?

The FDA and other regulatory agencies work very hard to protect participants in clinical trials. There are extensive specific regulations and guidelines for clinical research to protect participants from unreasonable risks. Of course, some risks may be unavoidable because of the uncertainty inherent in drug research involving new treatments.


WHO SHOULD CONSIDER CLINICAL TRIALS?

Most people participate in clinical trials to gain access to new treatment options. Many have exhausted standard existing treatment options, and clinical trials offer an alternative medical option. In addition, participants gain access to expert medical care for the condition being studied. Other people participate in order to contribute to the advancement of medical knowledge.

Not everyone who applies for a clinical trial will be accepted and enrolled. Researchers develop specific eligibility criteria such as age, sex, type and stage of disease, medical history, and other biomarkers and allocate for a specific number of participants. Volunteers may be excluded based on eligibility criteria and/or the trial size.


WHAT ARE THE POTENTIAL BENEFITS AND RISKS OF CLINICAL TRIALS?

Participating in a clinical trial can have many benefits. Participants can gain access to new treatments before they are widely available, and if the treatment is proven to work, participants may be among the first to benefit!

Participants also have the support of a team of health care providers usually specialized in the medical condition being treated who will monitor participants closely. Not to mention, even if participants don’t benefit directly from the clinical trial, information gathered in the trial can help others and the research community.

Clinical trials also present risks and some down sides. The new treatments aren’t always better than current treatments, and there is always the risk of unpleasant, serious, even life-threatening side effects. Or the treatment may simply not be effective for the participant. Additionally, participants may need to dedicate more time and attention with the new treatment, visiting the study site on a regular basis and taking more tests than are normally necessary.

(Source: FDA website)