Abstract
Dear Editor:
The responsibility of palliative medicine specialists to further develop the science behind the art of our clinical practice is well documented. 1 However there remains an inertia and in some instances obstacles and opposition to the enrollment of palliative care patients in clinical trials. 2
Contemporary specialist training provides little exposure to the conduct and complexities of clinical trials. Few of us have been taught how to make contact with sponsors and cooperative groups, read a protocol carefully, understand good clinical practice, or have the wherewithal to deal with the complexities of opening a trial. This includes budget negotiations, legal and insurance issues, ethics submissions, and research governance. Conducting a trial requires expertise as an investigator, a cadre of experienced research nurses and data managers, as well as financial oversight and an ability to withstand an external audit of site data and trial conduct.
But how does one get started in running trials if you need experience to start in the first place? The answer of course is to use the expertise of others, and/or use of the experience and wisdom of a cooperative group such as the Palliative Care Clinical Trials Collaborative. 3 Our department has an excellent relationship with a medical oncology unit that has an extensive trial portfolio, streamlined administrative processes to open trials, and experienced investigators and research staff. Leveraging this expertise and experience has been instrumental in getting started.
Why should a patient consider a trial when nearing the end of his or her life? The justification comes from knowledge that the trials we offer have good scientific rationale, and are designed to minimize harm and provide clinically relevant answers that may improve care. We must keep in mind the emerging knowledge that patients on trials and those receiving care in hospitals that run trials may live longer and have better outcomes. 3
Incorporating discussion of trials into routine clinical practice takes forethought. For patients with delirium in our unit, the routine practice of a family meeting to convey the seriousness of the illness and limited prognosis it often heralds is followed by reiteration of the palliative approach and the treatments we have to ensure that comfort is provided to the best of our ability. With our trial in mind, we raise our limited understanding of the particular symptom in order to introduce the rationale for a clinical trial—this can take some getting used to.
So after a year of hard work, has it been worth it? Without doubt, absolutely. We now have five trials covering symptoms such as cachexia, constipation, and pain. They are a mix of pharmaceutical and cooperative group studies, and patient accrual has been strong, indicating a willingness of our patients to embrace the clinical trial approach. We have employed two research nurses and our investigators have acquired substantial knowledge. Of course, any benefit or harm to our patients is for our trials to assess; however the benefit to our science and to our art is definite.