Making Clinical Trials Safer for Human Subjects

By Baram, Michael | American Journal of Law & Medicine, January 1, 2001 | Go to article overview

Making Clinical Trials Safer for Human Subjects


Baram, Michael, American Journal of Law & Medicine


I. CLINICAL TRIALS

The pace of medical innovation is quickening, pushed by advances in biotechnology and pulled by growing demand for healthcare. Completion of the Human Genome Project has provided a multitude of data for determining genes and their functions, and stimulated the application of information technology and private capital for the development of new individualized drugs, gene therapies, and biomaterials for tissue and organ regeneration.1 Concurrently, demand for healthcare continues to grow, expanding the market for medical innovations that are proven in clinical trials to be safe and effective.2

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the federal Food and Drug Administration (FDA) to determine whether the products are suitable for routine use in healthcare.3 Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake.4 But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on humans.5

The clinical trial is "a point at which research and the practice of medicine intersect"6 because it is supposed to be designed and managed to achieve dual societal objectives: the generation of clinical evidence regarding the efficacy and safety of new products, information needed by the FDA to determine whether the products should be sold for medical use, and the responsible application of such products to selected human subjects for potential therapeutic benefit.7

In some respects, the clinical trial resembles the test procedures for introducing other new technologies into society. For example, the introduction of a new pesticide, aircraft, chemical manufacturing process, or method of producing energy, requires carefully designed field tests to discern gains, risks, and the adjustments needed to secure regulatory approval and societal acceptance. And like clinical trials, the test procedures must assure reasonable protections for workers and other persons exposed to these advances.8

Thus, the introduction of a new technology requires testing by conducting a carefully managed learning process with two main functions: an operational function to discern whether the new product or process can efficiently provide anticipated benefits, and a safety function to identify its risks, which may be latent and unknown at the outset, and to determine if these risks are manageable. Experience in many technological sectors indicates that the safety function is vulnerable to deliberate or inadvertent compromise when it is managed by proponents of the technology who are striving to achieve results which promise personal or organizational gain.9

II. GENE THERAPY TRIALS AND SAFETY ISSUES

Carrying out the safety function in clinical trials of new products containing genetically modified materials poses special challenges. Little is known or knowable beforehand about the risks posed by such advances, and many of the human subjects involved have been chosen because of their seriously impaired health, making them especially vulnerable to any risks. Compounding the challenge are contextual circumstances such as the multiplicity of individuals and organizations commonly involved in such a trial, making it a multi-party enterprise in which coordination and communication difficulties may arise and cause responsibilities to become diffuse and uncertain. In addition, there is urgency and pressure for success because of the substantial investment of capital, facilities and human resources over the long period of time usually involved in bringing a biomedical advance to market. 10

The universe of biomedical advances now being tested includes many gene therapies, products containing specially created genetic material to be delivered into target cells of a person with the intention of curing the person's genetically-based illness. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Making Clinical Trials Safer for Human Subjects
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.