Ethical issue in clinical trial............
Transfusion for Protocol Eligibility
N Engl J Med 2010; 363:1681-1682October 21, 2010
Article
To the Editor:
Over the past year, we have observed three instances in which patients with advanced cancer received blood products solely for the purpose of altering a laboratory value to satisfy eligibility criteria for clinical trials of new chemotherapeutic agents. The first patient received a transfusion of 25% albumin to meet the albumin threshold of 30 g per liter (pretransfusion level, 22 g per liter). The second patient required a platelet count of 50,000 per cubic millimeter to meet enrollment criteria (pretransfusion count, 48,000). The third patient required a hemoglobin level above 9.0 g per deciliter for enrollment. Her physician ordered the transfusion of a unit of red cells to raise her hemoglobin level above that threshold (pretransfusion level, 8.3 g per deciliter).
These are predictable ethical dilemmas that clinicians face when participating in clinical trials. There should be a formal process in place to ensure that patients are not forced to take the unnecessary risks of transfusion to access therapy in a clinical trial. We offer several recommendations that should help clinicians address the ethical dilemmas presented by this practice.
First, researchers need to carefully consider the eligibility criteria during trial design, particularly for laboratory variables that can be manipulated with transfusion. If criteria are listed, there must be a medical reason for excluding patients on the basis of these values; if clinicians believe that a specific criterion is arbitrary, with no medical justification, they may be tempted to provide transfusions that will help patients meet that criterion. Institutional review boards should carefully consider the eligibility criteria when approving protocols.
Second, clinicians need to explore all other possible options, including other trials at other institutions, and should try to correct the underlying laboratory value through treatment other than transfusion when possible (e.g., treatment of anemia).
Third, there should be a specific reference in the eligibility criteria as to whether the criteria may be met with the use of transfusion. If the decision is made to allow transfusion to meet certain criteria, the clinician should make this intention clear to the institutional review board, the transfusion service, and the sponsor of the trial. We caution against this practice, given the risks of transfusion. The real risks of transfusion must be presented to the patient.
Fourth, the scientific publication must disclose to the reader the proportion of patients who received transfusions in order to qualify for inclusion in the study.
Patient safety must trump all decisions for such patients. There should be few situations, if any, in which a patient receives a transfusion solely for the purpose of temporarily altering a laboratory value to gain admittance to a clinical trial.
Jeannie L. Callum, M.D.
Blair Henry, M.T.S.
Yulia Lin, M.D.
Sunnybrook Health Sciences Centre, Toronto, ON, Canada
jeannie.callum@sunnybrook.ca
Posted by : insulin , Date : 2010-10-27 , Time : 13:18:10 , From IP : 172.29.15.136
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