Clinical and Translational Science Institute
Advancing today’s discoveries to improve health for all.

Recruitment and Retention ResearchMatch Recognition

Mary Becker, Recruitment and Retention Manager at the CCTS, was recently featured in this month's edition of ResearchMatch Liaison. In it, she talks about the success the recruitment program has seen by running social media ads promoting ResearchMatch. 

"Overall, the campaign saw its highest engagement and return on investment (ROI) among older age groups, especially individuals over 65."

Congrats, Mary, for this recognition!

Read Mary's feature and the rest of the newsletter

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

Community Engagement Program Highlight

Sample of Resources

  • Community Scientist Academy introduces community members to the research and prepares for participation across the research lifecycle. The program is offered in multiple formats: hybrid, in-person, and asynchronous.
  • CCTS maintains a Community Advisory Board (CAB) in southeast Ohio where researchers can present ideas, projects and receive feedback from the members. The CAB is a collaboration between communities and researchers from The Ohio State University and Nationwide Children’s Hospital.
  • Appalachian Translational Research Network (ATRN) is a network of universities from several states within Appalachia that come together to focus on the health. The CE staff is active within leadership of the ATRN. The CE team maintains the Ohio State University, Nationwide Children’s Hospital, and community partner memberships.
  • Conversations About Research Ethics (CARES) is supported by Community Engagement to focus on various research ethical challenges. 
  • Facilitate relations between researchers and community members/organization for collaboration.
  • Consultation meetings with researchers to assist in identifying and facilitating engagement with various stakeholders. 
  • Repository of training materials/resources available for researchers looking to learn how to/best practices when putting together, conducting, and maintaining a community advisory board (CAB), introduction to or follow-up on resources available via CE consultation


The community engagement team is here to assist with building relationships between the research community and the community stakeholders. You can reach the team by emailing jeff.grever@osumc.edu or Beverly.stringer@osumc.edu.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

New Responsible Conduct of Research Course Meets National Institutes of Health and National Science Foundation Requirements

The Ohio State University Office of Research has developed a new credit-earning course to meet National Institutes of Health (NIH) Policy Statement on Responsible Conduct of Research (RCR) and National Science Foundation (NSF) requirements for training in the Responsible and Ethical Conduct of Research (RECR). GRADSCH 8000: Responsible Conduct of Research (Course ID 37106) will provide a practical overview of the rules, regulations and professional practices that define the responsible conduct of research.

Dr. Cynthia Carnes, who is the PI for the CCTS KL2 program and Senior Associate Vice President for Research Operations at Ohio State, points out that, "the NIH has a broad conception of what researchers need to know to conduct responsible research, and therefore, they have a long list of topics that should be covered in RCR training. Many courses cover a narrower range of topics. This course was explicitly designed to cover all of them." 

The course features weekly facilitated discussions from experts across campus. It is open to faculty, postdocs, graduate students and staff at the university. The 1-hour credit course will run during the spring term (January 8 - April 22) and take place on Thursdays from 10 - 10:55 a.m. in the Research Commons.
 
Registration for GRADSCH 8000 must be completed through BuckeyeLink. Postdoctoral researchers or staff can also sign up for this course using Graduate Non-Degree. The spring application deadline for Grad Non-Degree is Friday, December 15.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

ConsentTools

You can explore the toolkit by topic below, or complete a text-based learning module on all three topics:

  • Optimizing Key Information

    Provides guidance on how to optimize key information to facilitate understanding by providing simple tools and tips that anyone can apply.

  • Assessments

    Many people are at risk of impaired decision-making capacity, and researchers often overestimate how well participants understand and appreciate informed consent information. To address these challenges, researchers can assess participant’s understanding and appreciation using a reliable and valid assessment instrument.

  • Legally Authorized Representatives (LARs)

    A Legally Authorized Representative (LAR) provides, or maintains, informed consent on behalf of a research participant. An LAR may help researchers recruit participants who lack decision making capacity, or retain those at risk of losing it.

You can also learn about eConsent which involves using electronic devices (e.g., computer, tablet, phone) to obtain consent from a potential participant or legally authorized representative. Here, you can learn the difference between Researcher Assisted eConsent and Self-Administered eConsent Without Research Personnel, and ideas to keep in mind while creating an eConsent form.

ConsentTools is supported by the Bioethics Research Center at Washington University School of Medicine in St. Louis, MO. It was developed as part of a research study funded by the National Institute on Aging [1 R01 AG058254-01; PI James DuBois]. The aim of the study was to help clinical research professionals understand and adopt three evidence-informed practices for consent in clinical trials.

Learn More About ConsentTools.com

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

Open Access Publishing Agreements with No Author Costs Through University Libraries

Whether you're a faculty member, staff or student, as a corresponding author at a journal covered by an open access agreement, the Open Access fees are covered at no cost to you.

University Libraries have established open access agreements with 13 publishers that provide open access to thousands of journals and publications. For an in-depth understanding of each agreement and the publishers, explore more information on the Open Access Publishing Agreements page. The Detailed Table of Agreements: Open Access Publishing Agreements with No Cost for Ohio State Corresponding Authors (PDF) provides an easy comparison of the agreements, ensuring you have the information you need for informed decision-making.

University Libraries' comprehensive website: Transforming Scholarly Publishing @ Ohio State | Ohio State University Libraries (osu.edu) has more information about the efforts at Ohio State to enhance your publishing experience.

For specific questions or assistance related to open access, Maureen Walsh and Gene Springs are there to guide you. Reach out to them at TransformPublishing@osu.edu to explore the world of open access and make your scholarly impact.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

How Clinical Trials Work

You may have had sticker shock at some point when paying for a prescription.

Drugs can be expensive. The high price tag is largely because of the many years of research a company has to do to prove their drug works, and that it’s safe for you to use.

The U.S. Food and Drug Administration (FDA) has nothing to do with setting prices for medications, but it is the agency that determines if a pharmaceutical drug should be allowed on the market.

Getting that approval can take 10 to 20 years of testing, first in a lab, then on animals and, finally, on people, in what’s called a clinical trial. People volunteer in clinical trials to have a chance to try the drug and for the drug’s producer to know if works and is safe.

At any given time, many clinical trials are going on at hospitals and universities across the country to test drugs or other treatments to cure a disease or make it easier to deal with symptoms.

Every clinical trial has at least three phases.

Phases of a Clinical Trial

Drug Side Effects

Whether someone is willing to tolerate difficult side effects of a medication depends on how life-threatening their disease is and how many other alternative medications are available to treat that disease. For example, a cancer patient may be willing to risk having side effects such as nausea, swelling and off-and-on numbing of their hands and feet if the chemotherapy medication shows promise in saving them from cancer. But those side effects wouldn’t be considered acceptable for a medication to treat high blood pressure.

Drug vs. Placebo

Typically, clinical trials test a drug against not having any drug, to see if the medication being tested makes a difference in treating the illness. This means some participants will receive the drug being tested and some won’t. Typically, neither the medical staff nor the volunteer in the trial knows who gets what (called a “double-blind study”), so that participants are as unbiased as possible in reporting whether the drug helped with their symptoms.

The clinical trial volunteers who do not receive the medication being tested receive what’s called a “placebo.” That might be a syringe of saline solution or possibly a pill with no medicine in it.

If the medication being tested is for a serious illness or condition that can’t go untreated, all participants in the study will still receive standard medication already known to successfully treat that disease or condition. In this case, a group of trial participants might receive the new drug being tested along with the standard medication. At the same time, another group of study participants might get the standard medication plus a placebo. Then the researchers can compare the health outcome of each of the groups to see if the medication being tested is any better than the standard one.

Recruiting Volunteers

One of the challenges with clinical trials is recruiting volunteers. It’s particularly challenging to find volunteers among:

  • People living in rural areas
  • People of color

Most clinical trials are done at major universities and large hospitals, which aren’t often found in rural areas. As a result, it can be difficult to recruit people who are able to drive to the study location for tests to see if the medication worked.

White people make up the most people who participate in clinical trials, though there are a lot of efforts to attract more people of color. Efforts are made to ensure that drugs are being tested across a wide variety of people from different areas and ethnic groups. But more work needs to be done so that researchers have enough data about all groups of people who might eventually have the drug prescribed to them.

Clinical trials can only be done if enough people volunteer to be in them. It can be a time commitment, and not everyone can do that. For those who are able to participate, their contribution helps make more medications available to either stop illnesses or make it easier to live with them.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

Using Recruitment and Retention Services at the CCTS

Consultations are available to help research teams with everything from sharing best practices for providing great customer service to explaining the different recruitment tools and methods that can be used to help you meet your recruitment goals.

“Our research group has had incredible success recruiting participants utilizing the CCTS Recruitment and Retention Marketing Program! Through the program, we have been able to better interact with the community and meet our recruitment goals at record speed. The CCTS team is great to work with and helps at all steps of the process.”

Emma
Clinical Research Coordinator

Services offered from our Recruitment and Retention program include: 

  • Listing your study on StudySearch, an Ohio State-specific website dedicated to clinical trials at Ohio State
  • Training on ResearchMatch, a website connecting participants to research studies
  • Social media advertising for clinical trial recruitment
  • Using MyChart for Recruitment
  • Aid in creation of marketing materials for your study

To schedule a consultation email, go to myccts.osu.edu.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

CCTS Receives CHOIR Award

The Ohio State University Center for Clinical and Translational Science Recruitment and Retention program was granted the Catalyze and Harmonize Operational Innovation for Recruitment (CHOIR) award for $31,500. This 5-year grant from the National Center for Advancing Translational Science (NCATS) and from Vanderbilt University will allow us to continue supporting the Trial Innovation Network operating as the Recruitment Innovation Center.

CHOIR will allow us to harness and harmonize expertise from many expert stakeholder groups (e.g. community engagement, informatics, recruitment and retention, evaluation, health equity and many more) to create real-world solutions in support of rigorous, reproducible research designed to improve human health.

Mary Becker, Recruitment and Retention Program Manager, states that she is excited to get started on the new aims of this project by making efforts to connect with the community and share the message of the importance of participating in research. Dr. Michael Para, The Ohio State University’s CCTS Director of Regulatory and Recruitment, says that “Mary and her team work relentlessly to ensure that research teams here and from Nationwide Children’s Hospital, have the tools and resources they need to be successful in their recruitment efforts and this award will give them additional resources to continue that important work.”

If you are interested in participating in a clinical trial at Ohio State, visit StudySearch. If you want researchers to reach out to you, create an account at ResearchMatch and be matched with trials that you may be a good fit for!

If you recently received funding and don’t know where to start recruiting, reach out to our Recruitment and Retention team at Mary.Becker@osumc.edu  and Clara.Kalis@osumc.edu.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

CDME M4 Lab Collaborative

M4 Lab Collaborative (CDME)  is a core service available under the CCTS Voucher Program. Engineering and clinical experts work collaboratively to find innovative solutions for real-world needs in clinical medicine. 

M4 offers engineering services to assist clinicians in translating their needs into healthcare solutions. The team of biomedical, mechanical, materials, electrical, software and quality engineers support the design, testing and fabrication of medical products for user, animal and cadaver studies. M4 works with customers to advance their research tool, medical device, diagnostic, therapeutic and other medically based innovations to drive outcomes that change clinical practice, enhance patient care and improve patient health. They design with the regulatory pathway in mind and are familiar with the clinical trial process, thus leading to outcomes that take innovations from “bench-to-bedside” to improve health outcomes. M4 has a diverse portfolio of projects supporting clients with a wide spectrum of healthcare product types, including surgical tools, implantable electromechanical devices, wound care, diagnostic testing devices, therapeutic devices and surgical training/pre-planning tools. 

Visualization of a healthcare product design using applicable design tools for translation into a prototype is a key step in the product development cycle. Customers bring projects to M4 in various development stages (idea, sketch, non-functional prototype or unrefined alpha prototype) for the development and refinement of that design. M4 offers design tools such as artistic renderings, computer-aided-design (CAD) images, functional and non-functional prototypes via additive manufacturing (also known as 3D printing) and other agile fabrication methods. Their additive manufacturing equipment can produce items using polymers, biomaterials, continuous fiber composite and metals and they have full machining capability to work with nearly any material required. 

The scope of CDME capabilities in medical product development includes:  

  • Translation of user requirements and proving feasibility with fabrication of demonstration units 
  • Design refinement for functionality, manufacturability and assembly 
  • Design of injection molded, machined and additive prototype units to prove out the design and manufacturing methods 
  • Prototype fabrication for user demonstrations or animal and cadaver studies 

New product and process functional prototyping is a core competency of M4. CDME houses or has access to resources required to create fully operational prototypes. In addition to design and fabrication, CDME houses several mechanical and electrical testing systems which are utilized in testing of client projects. They also have access to testing systems throughout the university to support prototype testing. 

More information on CDME

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

Former KL2 Scholar Receives METAvivor Research Award

Mathew Cherian, MBBS, assistant professor of Internal Medicine and medical oncologist who specializes in the treatment of breast cancer, received a METAvivor Research Award to fund his research to help treat metastatic breast cancer. Dr. Cherian’s work aims to determine the potential of a new class of drugs called sulfatase 2 inhibitors to treat metastatic triple-negative breast cancer, prolong patient survival and improve their quality of life.

METAvivor's research mission is twofold: to increase awareness about the funding discrepancy that shortchanges metastatic research in the cancer world, and to directly fund the metastatic research. METAvivor awards grants for research projects that have the potential to shift metastatic breast cancer from a terminal disease to a chronic condition people can live with. Dr. Cherian’s grant from METAvivor will further propel his research around design of therapies to improve outcomes of those with metastatic breast cancer.

Dr. Cherian was a KL2 scholar at the Center for Clinical and Translational Science (CCTS) from June 2019 to May 2022. The KL2 program supports the career development of investigators who have made a commitment to conduct either patient-oriented or translational research. To date, the CCTS has helped fund 40 investigators through the KL2 program since 2009 as they develop successful clinical and translational science careers.

Read Dr. Cherin’s abstract report of his research

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute. 

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