Clinical studies are very explicit in the eligibility criteria of patients they enroll. For mesothelioma patients, this may mean that only patients who have undergonespecific procedures are eligible. Other studies may only enroll patients who are not candidates for surgery. Most protocols require pathologic confirmation of mesothelioma, and require that patients have a reasonably good baseline function, meaning that they are otherwise healthy enough to tolerate the trial.
All clinical trials need to be approved by the hospital’s Institutional Review Board, which is a panel of clinicians who review clinical protocols/studies, ensuring that they meet standard ethical requirements. Many Cancer Centers also have committees that review studies for scientific merit, determining which studies are worthwhile to open, and should then be reviewed by the Institutional Review Board. All clinicians involved in clinical protocols/studies must periodically take courses and undergo testing to assure that they understand and adhere to the ethics of human research. Institutions must make efforts to assure patient confidentiality and must not coerce patients to enroll in any study in any way (i.e. inappropriate financial incentives, targeting vulnerable patients such as prisoners, etc.). Research studies that investigate new drugs or drug combinations must describe how they are going to monitor the safety of the protocol treatment (i.e. reporting side effects to a data safety monitoring committee).
All patients enrolled on any study must be mentally and legally capable of offering consent. Patients must be able to review, understand and sign an informed consent which outlines the purpose of the study, the study treatment/interventions, possible side effects from the treatment/intervention, any out of pocket costs the patient might incur as a result of enrolling on the study, and who to contact if the patient experiences problems related to the study. Once consent is signed, the patient has demonstrated an understanding of and willingness to participate in the study. At any time, a patient can refuse the treatment/intervention offered by the study, and at any time the patient can ask to be removed from the study. A patient who refuses further treatment/intervention can still continue to participate in the study (i.e. continue to have data recorded for study purposes), and often it is appreciated if the patient does this, since it may be important to keep track of those patients who decline and/or could not tolerate the treatment/intervention.
Next, learn about how mesothelioma clinical trials are organized.