"Who Coordinates Clinical Trials? "
As with most medical care, the point of contact is usually a nurse who acts as care giver, advocate, and coordinator. If a physician refers a patient to enroll in a clinical research trial, the initial contact for screening of eligibility criteria and informed consent process will most often be with a Research Protocol Nurse (also known as a Clinical Research Coordinator, (CRC). Oncology CRCs are usually former oncology nurses with a special interest in research. Requirements to become a CRC include specialized training and a scientific/clinical background. The Association of Clinical Research Professionals offers a CRC training course and a CRC FDA Exam Certification. ACRP is the largest worldwide clinical research professional organization, and has certified over 10,000 professionals to date.
CRCs work at the clinic under the supervision of the Principle Investigator of the study protocol, to coordinate the logistics of the tests for eligibility and outline the calendar of events for the patient. Most importantly, CRCs may perform the informed consent process, register the patient for randomization, act as the point of contact throughout the trial period and document all side effects of the study drug. CRCs are responsible for maintaining the Case Report Form (CRF) which is the document that stores the patient’s research data during the trial. The CRF must be separate from the patient’s medical chart. Furthermore, the CRF must remain anonymous without any patient identification to protect confidentiality. For all communication with the sponsoring pharmaceutical company, the CRF may reference the patient by a unique protocol identification number. This reveals the details of the patients’ medical case to the researcher without compromising patient anonymity.
Another important documentation performed by the CRC is the side effects of an experimental drug, known as an adverse event (AE). All new symptoms, complaints, abnormal labs, or side effects while on a protocol must be documented and graded according to the NIH Common Toxicity Criteria (CTC). This 0-5 scale requires the investigator to document if the side effect is clinically significant and if attributed to the study medication. Adherence to this scale maintains conformity among investigators and thus prevents bias in the toxicity results of the research trial. Any hospitalization or grade 4 toxicity is considered a Serious Adverse Event (SAE) and must be reported within 24 hours with an investigator summary. The protocol sponsor and medical director then immediately alert all investigators about the new SAE and precautionary measures. Grade 5 toxicity is life threatening or death from a toxic complication and immediately places the trial on hold. Ultimately, if the FDA approves the study medication, it will require a package insert that list the incidence of all toxicities found during the trial.
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