Recruitment Operational Guides & Resources
Connect the Right Patient to the Right Treatment
Lead Generation
Call qualifying members within an hour of alert
Call, Email & Text Once Every Third Day x 3 (leave different messages)
Calls in between messaged calls are permitted with no message (ie call day 2 but don’t leave a message)
Call weekly with text, email, and voice mail x 3 weeks
Stop calling after 6 messages and 4 weeks have passed
Eligibility
Call qualifying members within an hour of alert
Call, Email & Text Once Every Third Day x 3 (leave different messages)
Calls in between messaged calls are permitted with no message (ie call day 2 but don’t leave a message)
Call weekly with text, email, and voice mail x 3 weeks
Stop calling after 6 messages and 4 weeks have passed
Medical Record Aquisition
In the medical records folder, you can find all of the people you will be getting medical records for. You will see two separate folders in there. You will receive an email with a pdf attached containing a new patient’s MRR. The patient’s name will also be automatically populated into the “emailed pdfs” tab in the Medical Records Table.
Save PDF from email and rename it MRR AA (patients initials)
Create a folder for the patient and add the pdf
Update the Emailed PDFs tab to say created
Make a Copy of the Fax Cover Sheet Template
Create a fax cover sheet for each doctor listed
Rename the title of the document to be “FAX COVER SHEET (patient first and last initial for example AB) Dr. First and Last Name so an example: FAX COVER SHEET AB Dr. John Smith”
Add these documents to the patients folder
Call the doctor’s office to get the fax number for medical records specifically using 8×8
Add the patients information and doctors information into the table
Send Fax in 8×8 (adding the cover sheet first and then the MRR) with the subject: Attn: Dr. First Last
Update the table that the fax has been sent
Either a few hours later or the next day, call the office using 8×8 to confirm that they received the fax
Continue to call them every few days to see any updates or progress and document these notes in the table
Make sure to update the table with all dates and notes
Check by fax and mail to see if the records are received and once they are, download them into the patients folder and update the spreadsheet
If it has been 3 weeks and we haven’t received anything then please reach out to me ([email protected])
Research Coordinator Communictaion
This step in the process takes place after pre-screening once we have the patient’s documents ready to be transferred to the coordinator. The pharmaceutical company conducting the trial will share a list with information on the sites. Using this, we will call the site and explain who we are, what we have done and any other relevant information. We will then send them an email with the password-protected information and they will contact the patient. From here we want to check in with them to get updates and document this is our own system.
Call the study coordinator to transfer the patient. Make sure to establish a good relationship. The coordinators will be much more willing to answer your calls in the future.
If necessary, update the coordinator contact information
Always try to be in contact with the main coordinator and maintain that good relationship. Occasionally send gift cards etc.
Transfer the patient folder to the coordinator via email
Update table with relevant information
Check-in with the coordinator to get status updates (patient unresponsive, pre-screening, reviewing medical records, screening, randomized). I will do this weekly.
If the coordinator is unresponsive after multiple attempts at contact then have Dr. Kumar intervene and email the PI at the site.
If the patient is unresponsive then we will step back in and contact the patient ourselves to see if they are still interested. If they are, then let the coordinator know and/or attempt to do a warm transfer if possible.
Continue to update all relevant tables with new information
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. Â 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.
There are many investigational medications currently being studied. These investigational treatments attempt to help improve patient lives in many ways.
Breakthroughs can only happen with help from people like you.
Benefits of participating in clinical trials at no cost to patients or their family may include:
Lab Work
Neurological Exams
More Access to Physicians
Investigational Medications
Lodging and Meals
Travel for Caregiver &Â Patient
To find treatments and ultimately a cure for diseases, patients need to volunteer for clinical trials. Many trials fail, and most are delayed because of limited patient participation. All clinical trials need volunteers.
Clinical Trials FAQs
- Overview: Clinical trials are done with human volunteers to add to medical knowledge to try and find new ways to treat, prevent, or detect diseases. They are a way to test if new investigational medications are safe and effective in treating the disease they are intended for. There are two types of clinical trials-interventional and observational.
- Types of studies: Interventional studies are what people typically think of when thinking of research. Individuals are given a certain intervention (medication, surgery, etc.) to see if it is helpful. Observational studies gather important information about diseases and often look at cause and effect relationships. Patients in observational studies are not offered any new treatment options.
- The idea for a clinical trial usually starts in a laboratory. Researchers first test their new product with animals to see if it does what they hope. They look to see if it is safe and helpful. Once this is done, the drug can be tested in humans to see if we get the same results
- Sponsor: Every study is funded by an organization such as a pharmaceutical company, federally funded agencies (such as NIH), or an individual or organization. They are referred to as the sponsor of the study. The sponsor makes a lot of decisions about the study and chooses sites (or locations) that the study will be performed.
- Site: There are many locations that the study can be performed. At each site, there is a principal investigator (PI), who is usually a doctor, and study coordinators that conduct the study. While you are in a study, you will generally see the same study coordinator and provider throughout the study. Most of the study tasks will be done with the study coordinator, and they should be your primary contact throughout the study.
- Protocol: Each study has a written out plan of what everyone conducting the study needs to do; this is called the protocol. The protocol is written to protect the participants’ health and answer a particular research question. The medication and dosages are reviewed in the protocol as well as who is eligible for the study. The protocol also outlines what needs to be done at each visit and what time period they need to be done in.
- IRB review: Studies are reviewed by an independent committee called the Institutional Review Board (IRB). The IRB reviews the protocol and study materials to confirm that, in their eyes, the risk is worth the potential benefit in the study. The primary goal of the IRB is to ensure the rights of the participants are maintained and the study is conducted ethically.
- FDA: The Food and Drug Administration (FDA) also provides oversight to interventional studies to also ensure that volunteers’ rights and welfare are maintained and that the data is accurate. The FDA provides guidance on what should be done during a study. Once a study is completed, the sponsor can submit their data to the FDA to be reviewed. The FDA decides if there is enough evidence that the investigational medication is safe and effective to be approved and prescribed.
- Phase 1: This phase of studies is done with a small number of patients, typically 20-100 people, either healthy volunteers or people with the disease. Phase 1 studies are used to evaluate the safety of the drug, determine a safe dose, and look at side effects. This phase does not look at the effectiveness of the drug at all. The FDA states that approximately 70% of drugs move on from this phase.
- Phase 2: Phase 2 studies are done to determine the effectiveness and further look at the safety of the investigational product. This phase of study is done in up to several hundred patients with the disease. The FDA states that approximately 33% of drugs move to the next phase.
- Phase 3: In phase 3 studies, 300-3000 patients with the disease participate to further look at the safety and efficacy of the investigational product. The FDA states that approximately 25-30% of drugs move to the next phase.
- Phase 4: These studies with several thousands of patients and are done after the drug has been approved by the FDA to provide further long term data including risks, benefits, and optimal use.
Not everyone can, or has the desire, to participate in clinical trials, but finding volunteers is very important. A drug may look promising in animal models, but it needs to be tested in humans to ensure that it is safe and effective. New treatment options cannot be approved without clinical trials. One of the biggest obstacles in getting new medications approved is recruitment. Sponsors consistently have challenges getting enough patients into their studies in the time that they had predicted. This is costly, delays therapy, and can discourage further clinical research.
- Hope: many patients find that working towards new treatment options gives them hope; not only for themselves but also for future generations.
- Medical attention: In clinical research, your safety is our primary concern. Safety is constantly being monitored, and you will be made aware of any concerns that may arise. If, during a trial, we find that we cannot treat you adequately, or your safety is jeopardized, you will be removed from the study. Additionally, you have more frequent visits with doctors who are monitoring your condition while you are participating in the study.
- New options: When you participate in a clinical trial, you have the chance of receiving new, cutting edge therapies that are not currently available. Since this is an investigational product, it cannot be promised to you that this will help your 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 definitely receive the investigation product without a chance of placebo. This is called an open-label.
Inclusion/Exclusion: Each study has criteria that the participants must meet called inclusion/exclusion. These include things such as age, gender, disease stage, medical history, and medications that they are currently taking. Inclusion/exclusion criteria are not created to exclude certain patients from research studies. The criteria are created to ensure that participants are safe and that the data is precise.
All clinical research is completely voluntary. Before you decide to participate, it is important that you have been given all the information to make your decisions. It is good to ask questions about the study to decide if it is a good option for you.
- The study
- What is the purpose of the study?
- How does the investigational product work?
- What are the dosages and chance I will be on placebo?
- How long does the study last?
- How many visits are there?
- How long is each visit?
- What is expected of me during the study?
- Does someone have to come with me to the visits?
- Potential risks and benefits
- How many people has this investigational product been studied in before?
- Possible side effects?
- What other options do patients with my disease have?
- Participation
- Will I be able to continue taking my current medications?
- Who will be in charge of my care?
- Will the doctor be able to change medications if needed during the study?
- Costs
- Will travel be covered?
- Do I have to pay to be in the study?
- Will I get paid to be in the study?
- Will my insurance be charged?
- Time: Each clinical trial requires your time, but the requirement for each study is different. Before enrolling into a clinical trial, it is important to know how much time you will need to commit to the study.
- You should personally weigh the risks and benefits involved in the study and make sure that you feel comfortable.
- Each study has different risks associated and you 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 treatment options available because while in the trial you maybe limited to other treatment options. However, if another treatment is clearly better at any time during the trial, your doctor will take you out of the trial to provide you with the best possible care.
- Many clinical trials do not help the patients involved.
- Informed consent: The informed consent document is created to ensure that each patient completely understands the study and makes an informed decision about their participation. The consent form contains information about the risks and benefits, the purpose of the study, duration, and procedures.
If you are interested in a study, you will be given a consent form to review. It is encouraged that patients take time to read this document fully and ask any questions that they have during their review. Once a qualified participant reviews the consent and decides that they would like to enroll in a particular clinical trial, they will be brought to the site.
Your first visit will begin by reviewing the informed consent form with the research staff. If you decide to participate, the informed consent document will be signed at this time. Â If a patient is cognitively unable to sign for themselves, they can verbally agree to the study and their legally authorized representative can sign the consent form on their behalf. The informed consent is not a contract; you are free to withdraw from the study at any time. Â The informed consent is an ongoing process and the research staff should ensure that you want to continue to participate throughout the study.
- Confidentiality: Confidentiality is important to patients and researchers during clinical trials. When you participate in a clinical trial you are given a random number so that your name is not associated with the data you contribute throughout the study. As with a regular doctor, researchers are required to be HIPAA compliant.
- Drug vs placebo: Most phase 2 and 3 studies are randomized. This means that each patient is randomly assigned to get one of the dosages of the investigational product or placebo. Generally, neither you nor your doctor will know what you were randomized to during the trial. Randomization creates groups that are as alike as possible. This is important in clinical trials because it allows the data from the control group to be compared to the group on the study medication. This comparison provides the best way to prove the effectiveness of a new medication.
- Visits: Each study differs in how many visits there are, the lengths of the visits, and what is done at each visit. During the study, you will be required to come to the research site and perform the procedures outlined in the informed consent document; this generally includes safety measure, like blood draws and vitals, and questionnaires to help determine if the investigational product is working.
- Communication: While you are participating in a clinical trial, it is important that you are open and communicate with your research coordinator. The research coordinator needs to be made aware of any changes to your health; even if you do not think it is related to the study medication. It is also important that you communicate any medication changes that you and your doctors would like to make while you are on investigational product. This is for your safety to ensure that none of your medications interact.
The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. The main elements of the Common Rule include: Requirements for assuring compliance by research institutions, requirements for researchers’ obtaining and documenting informed consent, and requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. The Common Rule also includes additional protections for certain vulnerable research subjects: Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses, Subpart C contains additional protections for prisoners, and Subpart D does the same for children.
The FDA Good Clinical Practice regulations are a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.