Advantages and Disadvantages of Mesothelioma Clinical Trials

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Advantages of clinical trials include:

(1) Studies allow the opportunity to receive break through treatments, which have the possibility of being more effective than standard treatments

(2) Patients who enroll in studies help future patients with the same condition, by allowing researchers to answer scientific questions about the efficacy of the study treatment.

(3) The study protocol has undergone rigorous review. As described above, every institution with an available clinical study has an institutional review board which reviews all protocols open at that institution to assure adherence to ethical standards, and many institutions have committees which review the scientific basis and design of the study. Studies sponsored by drug companies have also undergone thorough scientific review by the drug company. National or international cooperative group (see above) studies have been extensively reviewed by multiple cooperative group committees, each made up of national/international experts, as well as the federal Cancer Therapy Evaluation Program (CTEP). For these studies, the treatment plan has been determined by a consensus of national of experts, who delineate strict treatment and follow-up guidelines for the study, to assure adherence to a national standard; often there is patient monitoring for quality assurance. For example, to assure correct diagnosis, the study may require sending biopsy tissue to a national expert to confirm the correct diagnosis.

Disadvantages of clinical trials include:

(1) The experimental treatment may not be effective and/or may have severe side effects. For studies which compare an experimental treatment with standard treatment, the experimental treatment may be no more effective (or less effective) than standard treatment,with possibly greater side effects.

(2) For randomized studies, 25-50% of patients will not receive the experimental treatment- depending on the number of treatment arms (usually 2-4) and the stratification (usually 1-2 patients are randomized to receive an experimental treatment for every patient who is randomized to not receive an experimental treatment). Furthermore, it is possible that the treatment will be a placebo — an inert substance with no efficacy against cancer — and neither you nor your doctor will know that. The reason for using placebos is that the researchers want an unbiased assessment of how well the experimental treatment is working. By not knowing whether or not a placebo is given, neither the patient nor doctor will be biased one way or the other (consciously or subconsciously) in assessing treatment response or side effects. If it possible that you could receive a placebo, you will be informed of this, and the protocol consent will explicitly mention this.

(3) There may be an extra commitment of time, such as filling out surveys and questionnaires or undergoing additional diagnostic tests. The study may require additional blood draws. When protocols mandate additional diagnostic testing or blood draws, there may be compensation for this, though the compensation is necessarily not excessive, as this can be considered a form of coercion (and most studies do not have the budget to finance more than small compensation).