Welcome to the Clinical Research Center!

It is the mission of the Marshall Clinical Research Center (MCRC) to assist our physician and research investigators with every aspect of attracting, designing, conducting and successfully completing clinical trials at Marshall. Our goal is to help make sure all clinical research is safe, appropriate, well-designed and provides the best chance for improved patient outcomes, publication and successful grant applications. For industry-sponsored research, the MCRC wants to insure your clinical site is selected for participation, study and regulatory documentation is complete, IRB submission contains all the essential information for approval, and contracts and budgets meet all the legally-required language and financial requirements to conduct a successful clinical research trial.

It is our aim to help you navigate through the processes and eliminate some of the problematic issues that often prove frustrating to physician investigators. It is important to remember that the MCRC and the IRB exist to make sure all research at our institution is done ethically and in compliance with all regulatory and legal requirements. We must all be vigilant to insure the research at Marshall University is in keeping with the highest achievable standards. Every research project is important to establishing Marshall University as a premiere research institution; a sponsor-preferred clinical drug trial site and a leader in investigator-initiated grant-supported studies and every study must exemplify the very best effort we can offer. We do not expect our physician investigators to bear that burden alone. The MCRC is in place to allow our clinician to keep their focus on the clinic and the critical aspects of their research.

How can the Clinical Research Center help you?

The MCRC staff has expertise in research study design, statistical analysis, and 15+ years of experience conducting hundreds of clinical research trials for industry. The team can assist and guide you with:

Trial start-up:

• Site selection visits by the sponsor, Training, Regulatory compliance, Regulatory packet submission to the pharmaceutical sponsor, IRB submission process, Contracting/Budgeting, Site coordination

Trial Conduct:

• Site set-up, Staff training and inservices, eCRFs (electronic case report forms), Study product management, Patient recruitment, Advertising, Informed consent process, Enrollment, Study conduct, Site monitoring visits, IRB reporting, Sponsor communication, Patient retention, Patient follow-up, Invoicing, Data collection, Adverse Event reporting, Study closure, Site audits

After the Trial:

• Results, Analysis, Publications, Future projects.

Contact us at 304.691.1836 to get started!

How much time will it require to participate in a clinical trial?

Physician investigators should be able to fit study participation into their schedules, no matter how demanding their clinic responsibilities. The primary rationale is: Study visits for your patients in trials can easily be incorporated into your regular practice schedule and usually require little more than what you would ordinarily practice as standard-of-care. The study may require extra visits and additional tasks but the study team will direct and assist you every step of the way to make things run efficiently and fit into your clinic practice.

Some things you will need to do on a regular basis: Meet with the coordinators, Review study issues and provide oversight for the study, Meet with the sponsor at regular site visits, usually 1-3 months per contract.

Why participate in a clinical research trial?

If you are considering a clinical research trial for your practice thinking you will reap financial rewards beyond your wildest dreams, think again. Pharmaceutical sponsors do pay for trial participation and the reimbursements for some trials or study-related tasks may initially seem attractive. However, there are hidden costs and study overhead is more than you realize. Better reasons to participate in clinical drug trials are: providing access to novel or cutting-edge treatments for your patients that would not otherwise be available to them, and the increased attention for patients in trials often proves to be an enormous incentive bonus for patients regarding their health care issues.

Research trials benefit both patients and practitioners. And if you identify a trial that is a great fit for your practice, successfully enroll, conduct the study according to protocol, and you negotiated a good budget, you might see some financial benefit.

What about investigator-initiated research projects?

If you are only interested in doing research of your own design, the Marshall Clinical Research Center can also provide support.  We have expertise in study design, data collection, statistical support, staffing and training to help you set up your own projects.

Industry-sponsored clinical research trials

Sponsors are always looking for physician investigator sites to place their clinical drug trials. The first step in this process is usually a site qualification questionnaire and visit.  The MCRC can assist you in completing the questionnaire and conducting the site visit. This is the first critical step that will convince a sponsor to choose your site to place their trial.

It is important to determine if the trial is a good fit for your site. If you think you have patients who will qualify for a trial, it’s reasonable to explore the trial parameters further with a study sponsor to decide if your patients will actually meet the often stringent inclusion/exclusion criteria to enter a trial. Read this information carefully and recognize that not every patient who qualifies will choose to participate. Be accurate in your assessment as to number of patients you are likely to enroll. Do not overpromise enrollment. This will only hurt your chances in the future. Often, despite best efforts, a study proves difficult to enroll to, so it’s important to choose wisely.

Do not make your decision solely on the basis of the budget. If a budget is unusually high, there may be a reason. Some clinical drug trials require resources, time and effort above and beyond what is anticipated. Others may fit easily into your regular clinical routine or standard-of-care. Pay particular attention to study visit schedules and windows for those visits. Read the protocol carefully in order to identify any costs not covered in the budget template.

Make sure you have adequate time to meet with study representatives for monitoring and follow-up during the study. These visits are important to your ongoing relationship with the study sponsor.  If you develop a good relationship with a sponsor, they will return again and again to your site for future trials.

Finally, don’t hesitate to say "no" to a trial at any point prior to start-up. Most sponsors appreciate your feedback and assessment if a trial is not a good fit, if you think your site will have difficulty recruiting appropriate patients to enroll or meeting the sponsor’s suggested enrollment goal. Both site and the sponsor invest a considerable amount of time and effort to get your site up and running. Some studies can prove difficult to enroll in spite of best efforts but you don’t want your site to develop that reputation. Remember: Your site may be a better fit for the sponsor’s next trial.

Contracting

The Marshall Clinical Research Center can provide critical guidance for negotiating contracts with industry. We can review your contract templates for content and language that is acceptable under WV law, and local requirements and regulations. All legal documents contracted with Marshall Health should be signed by an officer of the corporation. The MCRC can assist you with this in a timely fashion. Confidentiality agreements can be signed in 24-48 hours and contract negotiation requires an average turnaround time of 1-2 weeks

Getting Started – the IRB and IRBNet

For basic guidance on where to begin, standard operating procedures (SOPs), required education and training, and research resources, the Marshall University Institutional Review Board (IRB)/Office of Research Integrity (ORI) website page is a good place to start. There are quick links and more to each of these items.

IRB Website: http://muwww-new.marshall.edu/ori/

On this website, you will also find quick links to the IRB’s SOP and Investigator’s Manuals. These two items will address almost any question you have about the submission process. If you can’t find the answer, please contact the IRB or the CRC directly.

IRB Telephone: (304) 696-7320

MCRC Telephone:(304) 691-1836

Marshall University IRB uses IRBNet, a paperless web-based program for all research activities including submissions, continuing review and oversight. It’s very user-friendly and quick to learn to navigate.

IRBNet Website: https://www.irbnet.org/release/index.html

There is an IRBNet User Manual to assist you with registration, submission, and continuing review and you can locate all the forms you need for IRB submission and oversight on IRBNet.

Basic guidance and suggestions for investigators

The IRB and MCRC are here to assist you with your research project. Do not view guidance provided by these two entities to complete basic requirements as adversarial. The regulations and requirements are designed to be as painless as possible and to keep you and your research projects in compliance.

Marshall University is AAHRPP-accredited. There are specific and stringent requirements to achieve this accreditation and it is mandatory for all research investigators at Marshall to comply with local requirements in order to meet the necessary standards to earn and maintain this accreditation.

If you encounter problems with the process and view some of the documentation as repetitive or unnecessary, both the IRB and MCRC welcome your suggestions. We may also be able to provide you with some additional information about why some of the forms may seem unnecessarily complicated or redundant.

Stay focused on the goal, answer all the questions, fill in all the blanks and call if you need help!