The primary function of the advocacy team is to help the patient by connecting them to the right therapies (possibly investigational.) This goal is accomplished through well-documented patient interviews and at times medical record review. A compassionate communication style, detail-oriented documentation and a scientific approach are required to be effective.
Forty percent of clinical trials fail because of inadequate patient advocacy resulting in insufficient sample sizes thereby slowing the progression of medicine. This illustrates the crucial nature of this role which requires someone with a strong scientific foundation, great capacity for communication, and dedication to helping people in need. Advocates must have a strong moral compass and truly recognize the risks and consequences of both under recruiting for a trial and inappropriately placing subjects. At first, it might seem that these two risks are at odds but that is not the case. The advocate is successful by placing people into to trials when it is best for the person and best for the study. Advocates must vigorously educate candidates, diligently and relentlessly gain contact and often guide and support candidates who might no longer have the capacity, energy, or knowledge base to take the necessary steps to potentially benefit society and themselves through involvement in research.
Subjects might access investigational medicine that is otherwise unavailable. When subjects participate in a clinical trial, they have the chance of receiving investigational therapies that are not currently available. Since this is an investigational product, it cannot be promised that this will help their condition. Additionally, in phase 2 and 3 studies some patients do not receive study medication during the study. Some participants receive placebo (a sugar pill) so that they can be compared to the participants receiving the investigational product to see if it does make a difference. Many studies will give patients who complete the study the opportunity to receive the investigation product without a chance of placebo. This is called an open-label.
Additional access to specialized physicians and care should be considered. Subject safety is a primary concern. Safety is constantly being monitored, and subjects will be made aware of any concerns that may arise. If, during a trial, we find that we cannot treat subjects adequately, or their safety is jeopardized, they will be removed from the study. Additionally, they have more frequent visits with doctors who are monitoring their condition while participating in the study.
Hope is a powerful thing. Many patients find that working towards potential new treatment options gives them hope; not only for themselves but also for future generations.
Advocates are responsible for determining with the candidate whether they can meet the time requirements associated with research. Each clinical trial requires the subjects’ time, but the requirement for each study is different. Before enrolling a subject in a clinical trial, it is important they know how much time they will need to commit to the study.
Candidates should personally weigh the risks and benefits involved in the study and make sure that they feel comfortable. It is the advocate’s job to make sure they understand these risks. Each study has different risks associated and the advocate should reference the Informed Consent Form for known potential side effects. Since these are investigational treatments and medications there may be unknown side effects.
It is important to consider other options available to the candidate because while in the trial the candidate may be limited from treatment options. If another treatment is clearly better at any time during the trial, the doctor should take them out of the trial to provide the best possible care.
It is important that the candidate understands that many clinical trials might not help the patients involved to get better.
Target patients of the PI first it’s a quicker process because there is no need to collect medical records and the doctor is familiar with the trial.
When screening these people, make sure they 100% pass the I/E since we will not be collecting records to verify. We don’t waste people’s time, and we want to show them we are identifying high-quality candidates. Make sure to ask the subject when the last time they saw their doctor was, and if the doctor brought up any clinical trials at that time – document this.
Send the ICF if I/E if authorized by the sponsor.
When you follow up on the ICF, answer any questions and ask if they are still interested. If they are interested in participating, document the next time they will be seeing the study doctor. This is important. If it is soon, we want them to show up to the visit with the ICF in hand and specifically ask the doctor about it. Contact the site coordinator and make them aware that this candidate will be in the clinic *appointment date/time* and they will be showing up with an ICF looking to speak to the doctor about it. Let the coordinator know we asked them all of the I/E criteria questions over the phone and they seem eligible to participate, and we reviewed the ICF with them and they are interested in participating. Ask the coordinator to please review the subject’s chart with the study doctor to see if they agree this subject is a likely candidate. A site transfer doesn’t get any easier than that. If the appointment is further away that’s okay, call the coordinator and do the same as above and make the coordinator aware the next time the candidate is scheduled to come in. If the coordinator and doctor review the chart and agree this is an eligible candidate, they will likely schedule the subject for a screening visit before their appointment.
Always follow up with the coordinators accordingly to see if they have reviewed the chart and if/when the subject will be coming in for screening.