Where Do Clinical Trial Protocols and ICDs come from?

Photo by Chatham University

According to the Center for Information & Study on Clinical Research Participation (CISCRP), 94 percent of people recognize the importance of clinical trials in advancing medicine; but, 75 percent say they have little to no knowledge about how to participate.

And, unfortunately, those who do seek out clinical trials can find themselves feeling frustrated and overwhelmed by the huge volumes of information available on sites like ClinicalTrials.gov. It is often difficult for someone new to the clinical trial space to know where to begin.

When you read the real-life accounts of clinical trial participants and patients caregivers like Jeri Burtchell and Jenny Dwyer you quickly see that better tools and resources to navigate the world of medical research are sorely needed. In addition, the clinical trial culture could benefit from a shift toward patient-centricity. It’s important that patients know that they are seen as more than a data point; developing resources that help meet their needs before and after the trial may be a good place to start.

Why Do Patients Enroll in Clinical Trials?

People enroll in clinical trials for different reasons. Often, the reason people join a trial is to improve the quality of their care. Some believe they have no other treatment options. Others enroll because they wish to help advance medical research.

Most often, a patient’s journey into clinical research begins with their primary care physicians and specialists. According to research from CISCRP, most cancer patients who participate in clinical trials say that their physician had a great deal of influence on their decision to participate. Unfortunately, though, only 7 percent of patients say that their doctors have ever suggested that they participate in a clinical trial.

Clinical trials can be large, complex, and may involve many people, processes, and documents. In order to understand opportunities to provide better services to patients, let's consider who's involved in clinical trials, the roles they play, and the way information about the trial is shared with patients.

Clinical Trial Roles and Responsibilities

clinical trial protocol

The Sponsor

The sponsor initiates the trial to study a new drug, medical device or treatment option. They fund the research and do most of the data analysis during and after the trial to determine whether or not it was successful. The sponsoring organization can be a pharmaceutical company, a bio-tech company, a government agency, a not-for-profit or an academic medical center.

The Protocol

The sponsor is also the originator of the clinical trial protocol, which is basically an instruction manual for conducting the trial. All parties involved in conducting the trial must follow the protocol to ensure that the trial runs smoothly and that all ethical and medical considerations are taken into account.


In addition, sponsors may  choose to outsource to a Contract Research Organization (CRO) to help conduct the clinical trial. A CRO can help find study sites, investigators and recruit participants, and perform additional duties as specified by the sponsor.

The Institutional Review Board

The Institutional Review Board (IRB) scrutinizes the research plans for both medical safety and protection of the patients involved in the study. Before the board approves any study it can require  the sponsor to make changes in study's procedures or in the explanations given to the patient.

The Clinical Investigator

Photo by Phalinn Ooi

The clinical investigator has site-level responsibility to conduct trial.

clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. (Wikipedia)

The Clinical Research Coordinator

The investigator works closely with a clinical research coordinator (CRC) as part of their research team. A CRC is someone who ensures that all study documentation is recorded, handled and stored to allow accurate reporting. They are also responsible for making sure that information consent is given freely by study participants, and that their confidentiality is respected and protected. The CRC often works to gain IRB approval of a study at the site level.

The Informed Consent Document

The sponsor and the investigator research team are jointly responsible for writing the  informed consent document (ICD). The ICD serves to accurately inform potential subjects of the risks and potential benefits of participating in the study. It includes information about the drug being studied, possible side effects, and the procedures that will be performed during the trial.

Opportunities for Improvement

What role was left out of the above list? The patient.

There's greater opportunity for sponsors, IRBs and CROs to consult with patients and patient advocates early in the clinical trial processes.  Including the patient's perspective could help to ensure that:

  • Clinical Trial Protocols are aligned to both research and patient objectives. If physicians, researchers and patients were all able weigh in wouldn't that help to assure the best possible clinical trial design—one that includes patient-centered endpoints and inclusion/exclusion criteria to attract the right patient population?
  • Informed Consent Documents are presented in an easy-to-understand format. Rather than providing a lengthy, text-heavy, technical documents, maybe we could enlist the help of some user experience designers and provide a sleekly organized document enhanced with photos, charts, and videos that help patients gain a better understanding of the trial in less time?
  • Monitoring plans work with patients' needs and lifestyles. How could patients shape and provide feedback on monitoring plans and oversight, so that data and safety monitoring is clear, transparent and personal?
  • The research sites selected are well-equipped to provide a positive experience to the patient. Could patients have insight into facility and staff characteristics to help make site selection and trial execution more efficient?

Share your ideas with us.

At Lilly COI, we're experimenting with ways to put patients at the center of trials and building platforms from which they can share their thoughts, needs, and opinions about all aspects of clinical trial participation. And, you can help by participating in the Clinical Trial Visualization Redesign Challenge. Submit a design, or vote for your favorites when the competition ends this October.

Your ideas and insights are important to us, and could help make a difference in finding better treatments for patients. We look forward to hearing from you!

Design Challenge


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