The entire trial document

The roadmap described above is actually a very small portion of an extensive document describing all aspects of the clinical study. The entire document often exceeds 100 pages and covers the following topics: study hypothesis, experimental design, scientific background and rationale with relevant references from the scientific literature, patient eligibility and randomization, therapy for each arm of the study, required observations, pathology guidelines, radiation therapy guidelines (if applicable), supportive care guidelines, specific information about each drug, relapse therapy guidelines, statistical considerations, study committee, record-keeping, reporting of adverse drug reactions, and consent form.

The full protocol is intended for the use of specialists in oncology medicine and nursing, and is not written in lay language. It is highly technical, and can be confusing and/or overwhelming.

Some parents throw themselves into research to better understand their childs illness. These parents may want to have a copy of the study document for several reasons. First, it provides a description of some of the clinical trials that preceded the present one and explains the reasons the investigators designed this particular study. Secondly, it provides detailed descriptions of drug reactions, which comfort many parents who worry that their child is the only one exhibiting extreme responses to some drugs. Thirdly, motivated parents who have only one protocol to keep track of occasionally prevent errors in treatment. Finally, for parents who are adrift in the world of cancer treatment, it can return a bit of control over their childs life.

Since knowledge is comfort for me, I really wanted to have the entire clinical trial document, despite its technical language. Whereas the brief protocol that I had listed day, drug, and dose, the expanded version listed the potential side effects for each drug, and what actions should be taken should any occur I learned the parameters.

Parents have a right to review all literature and information related to their childs treatment. If you wish to read all of the details of the study, ask that a copy be provided to you. Informed consent documents for Children's Oncology Group protocols specifically inform families that they will receive a copy of the full protocol upon request. After you read the protocol, it maybe helpful to schedule an appointment with your physician, nurse practitioner, or research nurse to address any questions or concerns.

The protocol is not for general distribution, because use of these protocols outside a controlled research setting can be dangerous and is unethical. Thus, if you receive a copy, it should be for your personal use only.

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