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Research & Innovations

The Digestive Disease Clinical Research Unit is currently conducting clinical research projects.

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Digestive Disease Clinical Research Unit is actively enrolling clinical trials in the following areas:

Device and Surgery

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

A Randomized Controlled Trial to Compare the Functional Outcome and Quality of Life of Patients with Low Rectal Cancer who Undergo a J Pouch or a Side to End Coloanal Anastomosis.

Massarat Zutshi, MD

For patients with low rectal cancer requiring an abdominal proctocolectomy (surgical removal of the rectum together with part or all of the colon.) This study will compare bowel function and quality of life after surgery, comparing 2 surgical procedures (the J pouch or side to end anastomosis) which are used to join the colon and rectum. Patient participation will last about 2 years.

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal. (IMPROVE – Ileostomy Reversal)

Jon Vogel, MD

For patients scheduled to undergo surgery for ileostomy reversal. The main purpose of this study is to assess the total amount of pain medications used following surgery, and to determine if overall hospital costs can be reduced when using the study drug. The study drug will be injected into the surgical incision at the end of surgery while you are still asleep. It is thought that the timed release of medicine may provide prolonged pain control after surgery. Patient participation will end 30 days after surgery.

A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection versus Open Resection for Rectal Cancer

Luca Stocchi, MD

For patients who have rectal cancer which can be removed with surgical resection, who are undergoing chemotherapy and/or radiation therapy. This study will compare safety and effectiveness of the two types of surgery currently used for rectal cancer (Open Laparotomy Resection and Laparoscopic-assisted Resection.) Patients will be randomized to one of the 2 surgery groups. There are 15 study visits (including surgery), and patients will be followed annually for 5 years after surgery.

Timing of Rectal Cancer Response to Chemoradiation

David Dietz, MD

For patients who have been diagnosed with rectal cancer that has extended through the rectal wall (Stage II) or involves the lymph nodes outside the rectum (Stage III).

The aim of this study is to determine the best time to perform surgery in relation to chemotherapy and chemoradiation (chemotherapy and radiation given at the same time). We believe that by extending the interval between chemoradiation and surgery, and by giving the chemotherapy before surgery, there may be a greater chance that the existing tumor will disappear completely by the time of surgery. Patients will participate from the day of signed consent until 30 days after surgery (about 7 months total) with annual long term data collection (such as post-op therapy and disease status) recorded for up to 5 years following surgery.

Post-market Clinical Evaluation of the Spiracur SNAP™ Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

Michele Loor, MD

For patients with acute wounds such as post operative wounds, trauma wounds, pressure ulcers, and colostomy take-down sites. The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. This is an FDA approved device for patients who would benefit from a suction device dressing system. Comparison to patients with acute wounds previously treated will also be done, and clinical outcomes and complication rates will be evaluated. Patients will receive the SNaP® Wound Care System for up to 12 weeks, and will be in the study until the wound closes or week 12, whichever comes first.

A Randomized Controlled Trial to Compare the Efficacy of a Biological Implant, Biodesign (TM) Surgisis (R) Tissue Repair Graft, to Reinforce an Overlapping Sphincter Repair versus Standard Overlapping Sphincter Repair

Massarat Zutshi, MD

For patients who have previously been diagnosed with fecal incontinence (leakage of stool) and are scheduled to receive surgery to treat this condition. The purpose of this study is to see if placing a COOK® Biodesign™ Surgisis® Tissue Graft around the anus during surgery is more effective than repairing the anal muscle alone. Surgisis is a porcine derived piece of sterile tissue manufactured by Cook Medical Incorporated. Patients will complete a bowel diary and several questionnaires both pre and post op and will be randomized to one of two study groups (with mesh or "standard of care") before surgery. Patients assigned to the “standard care” group will receive the procedure as their doctor would normally perform the surgery. Patients assigned to the “Biodesign” group receive a piece of the Biodesign material. All other procedures and follow-up are completed as usual. Patient participation will last 24 months from the time of surgery. After discharge from the hospital, there will be 3 office visits over 2 years (standard of care visits at about 6 months, 12 months, and 24 months.) Patients may find out which group they were in upon completion of the study.

An Investigation of the Treatment of Fecal Incontinence using the TOPAS Sling System for Women. (TRANSFORM)

Massarat Zutshi, MD

This study is designed to measure the efficacy of the TOPAS Sling System , a permanent mesh that is surgically implanted with the goal of treating fecal incontinence in women. Patient participation will last approximately 39 months (9 study visits) including the completion of screening interviews, pre and post op bowel diaries, quality of life questionnaires, and follow up visits. All costs associated with the study are covered by the study sponsor. Please note that the TOPAS Sling System is not yet FDA approved for the treatment of fecal incontinence.

A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients with Chronic Constipation

Massarat Zutshi, MD and Vernon Lin, MD, PhD

For patients who have been diagnosed with chronic constipation. The purpose of this study is to evaluate the effects of Functional Magnetic Stimulation (FMS) on gastrointestinal (GI) motility in patients suffering from constipation due to non-neurological issues. FMS is relatively painless and can be applied over patient’s clothing. Patients will have SmartPill testing (to evaluate GI motility), Anorectal Manometry Testing (to measure pressures and electrical activity of the anal sphincter muscles), and will fill out questionnaires. Patients will be randomized to receive either FMS for 5 weeks or sham FMS for 5 weeks (at 5% intensity to induce some sensation but no muscle movement). 20-minute stimulation will be applied 5 days a week for 5 weeks. Patients who undergo a sham will be evaluated after 5 weeks and may be offered FMS for 5 weeks. Participation in this study will about last ten weeks total (30 visits).

Endoscopy, Esophageal and Capsule

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Barrett's Esophagus Study Trial (BEST) 2

Prashanthi Thota, MD

For patients who have been diagnosed with Barrett's esophagus (BE) and have undergone endoscopy procedures. This study will not impact clinical care. Patients will be sent a letter and questionnaire, with a follow up telephone call to assist them in completing the questionnaire. The purpose of this study is to gain understanding of which patients with BE are likely to progress to malignancy, and it is equally important to determine which patients are not likely to progress. The hypothesis is that the collection of data on the natural history of BE, and risk factors for progression of BE, will provide information to develop a risk model which will also be a useful tool leading to a reduction in overall health care costs.

Hepatology

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

A Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized with Dilutional Hyponatremia. Symptoms And Length of stay After sodium Correction in Inpatient Adults: Tolvaptan versus Fluid Restriction. (SALACIA)

Robert O'Shea, MD

For patients admitted to the hospital who have dilutional hyponatremia (low amount of sodium or salt in the blood). The purpose of this study is to find out the potential benefits of tolvaptan in relation to the symptoms and length of hospital stays of people with dilutional hyponatremia. Although Tolvaptan is approved for use by the FDA in adults with certain types of hyponatremia, it is not approved for either the relief of symptoms associated with hyponatremia or shortening the length of time in the hospital. Patients will be randomly assigned to take either Tolvaptan or placebo for up to 7 days or until discharge from the hospital, whichever occurs first. Patient participation will last about 15 days including a follow-up phone call.

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type I with Lucassin® (Terlipressin). (REVERSE TRIAL)

David Barnes, MD

For patients admitted to the hospital who have Hepatorenal Syndrome (HRS) type 1 due to severe liver disease. The purpose of this study is to test an investigational drug called Terlipressin to see whether intravenous Terlipressin is safe and effective to treat (improve or reverse) HRS type 1 when compared to placebo. Patients will be randomly divided into two study groups (Terlipressin or placebo) and will receive the study drug or placebo into their IV every 6 hours for up to 16 days, depending on kidney function test results. Patients will be monitored closely while in the hospital and will have follow-up phone calls for up to 3 months after the end of the study treatment.

An Observational Prospective REGISTRY to Identify Demographic and Clinical Characteristics of Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization

Robert O'Shea, MD

The purpose of this registry is to compare the effectiveness of different treatments, including no treatment at all, for hyponatremia (low levels of sodium in the blood). Each patient will already be admitted to the hospital and their treatment will be determined by their caregiver prior to enrollment. This registry will collect data from medical charts, including age, gender, race, medical history and discharge information.

Tissue Banking of Duodenal Fluid and Serum Samples from Patients with Pancreatic Diseases

Tyler Stevens, MD

For patients who are scheduled to have an endoscopy procedure to evaluate for possible chronic pancreatitis, pancreatic cancer, or are at a high risk of developing pancreatic cancer due to a strong family history. For a comparison group, we will also recruit patients without pancreatic diseases, including those undergoing endoscopy for other purposes, or patients with viral hepatitis undergoing a liver biopsy. Fluid may be collected at the time of endoscopy during a pancreatic function test or during endoscopic ultrasound. The fluid is analyzed to see how well the pancreas is working (to diagnose chronic pancreatitis) or for the presence of cancer cells (to diagnose cancer). We will ask questions regarding medical history and risk factors for pancreatic diseases (including smoking and alcohol use) and will obtain a small sample of blood and breath for analysis. We want to understand more about certain proteins, environmental factors and other causes that are involved in chronic pancreatitis and pancreatic cancer. To achieve our goals, we will store samples of blood, breath and intestinal fluid for future research purposes.

Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFN alpha-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFN alpha and ribavirin therapy. (ATTAIN)

Nizar Zein, MD

For patients who have been diagnosed with chronic hepatitis C virus (HCV) infection and had a response to treatment with Peginterferon alfa-2a (PEG) and ribavirin (RBV) which did not cure you from hepatitis C. The purpose of this study is to find out if an experimental drug called TMC435 combined with PEG and RBV works as well or better than telaprevir with PEG and RBV to treat patients with genotype 1 HCV who were non-responders to previous PEG plus RBV therapy. Participation in this study may last about 1½ years which includes screening, a treatment period of 48 weeks and a follow-up period. The follow-up period ends 72 weeks after starting treatment.

A 2-Part, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected with Genotype 1 Hepatitis C Virus Following Liver Transplantation

Nizar Zein, MD

For patients who have had a liver transplant within 6 months to 10 years ago, who now have genotype 1 chronic hepatitis C (HCV). The purpose of this study is to learn more about the safety and effects of the combination of telaprevir, peginterferon alfa-2a (PEG) and ribavirin (RBV)in patients with HCV who have had a liver transplant. Patients will receive treatment with PEG and RBV for up to 48 weeks, and will also receive telaprevir for up to 12 weeks. None of these drugs are approved by the FDA for use in patients who have had a liver transplant. Participation could last up to 101 weeks (screening, a treatment period lasting up to 48 weeks, and a follow-up period that will last up to 48 weeks), depending on your body’s response to the study drugs.

Inflammatory Bowel Disease and Nutrition

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Chung-Jyi Tsai, MD

For patients diagnosed with Celiac Disease who have been following a gluten free diet for at least 1 year and are actively experiencing symptoms of Celiac Disease. The purpose of this study is to look at the effectiveness and safety of three different doses of Larazotide Acetate. Patients will continue to follow their current diet and will receive study medication or placebo for up to 147 days. There will be 7 visits for tests and procedures and 1 follow-up telephone visit. Patients will be given a small hand-held electronic device to record daily and weekly diary information.

The Cleveland Clinic Foundation Inflammatory Bowel Disease DNA Bank

Jean-Paul Achkar, MD

This study is designed to recruit patients who have been diagnosed with IBD (Crohn's disease and/or Ulcerative Colitis) and their unaffected spouse/significant other/or family member (who is not genetically related). The purpose of the study is to identify the genes that cause Ulcerative Colitis and Crohn's Disease. The study consists of one study visit to include a consent form signed by both the affected and unaffected participants, along with information regarding family background and smoking history, and a donated blood sample. The affected patient will also be asked questions about their disease history, including but not limited to diagnosis, medications, surgeries and complications. The DNA, serum, plasma and accompanying information that is collected is strictly confidential and will be used in attempts to advance the understanding of genetics and IBD.

Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

Chung-Jyi Tsai, MD

Two types of patients with celiac disease will be enrolled in this study: newly diagnosed, and those who have been diagnosed with celiac disease who have been on a gluten-free diet for at least 12 months. Patients will complete 5 surveys by telephone and internet to answer questions about your symptoms and how the gluten-free diet affects your life.

Established Celiac Disease Patients will be assigned to 1 of 4 study groups. There is a chance that you will eat a small amount of gluten over an 8 week period. Participation will last about 12 weeks, including 5 visits and 1 telephone call. The purpose is to: 1) find out how small amounts of gluten eaten daily can affect common celiac disease symptoms; 2) find out the impact of living with celiac disease and sticking to a gluten-free diet on a celiac patient’s life; 3) test whether the PRO survey is a good tool to measure symptoms that people with celiac disease commonly experience; and 4) see if treated gluten that has been broken down can cause symptoms.

Newly Diagnosed Celiac Disease patient participation will last about 16 weeks including 5 visits and 2 telephone visits. The purpose is to: 1) find out how starting a gluten-free diet in newly diagnosed patients affects symptoms and how it impacts patients’ lives; and 2) test the PRO survey and see if is a good tool to measure symptoms that people with celiac disease commonly experience.

Liver Transplant and Hepatobiliary

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Enhancing DCD Utilization with Thrombolytic Therapy

Bijan Eghtesad, MD

For patients who have already consented to receive a liver for transplant from a person who donated this liver after his or her heart stopped (DCD liver) . The purpose of this study is to determine if post-transplant complications due to narrowing in the biliary system (a system that collects bile from your liver tissue and excretes it into your intestines), or a blood clot formation in the liver vessels, can be prevented or reduced by treating the donated liver with a clot dissolving medication called Activase (also known as Alteplase or rTPA). Patients will be randomly assigned to one of two groups: Group 1 will receive a DCD liver followed by standard post-transplant medications and medical care; Group 2 will receive a DCD liver which will be treated with clot dissolving rTPA medication before implanting. The liver will then be implanted into the recipient who will be followed by standard post-transplant medications and medical care. Patient participation will last about 12 months , we will collect the usual labs at your regular post transplant visits month 1,3,6,9, and 12, an additional test called an MRCP, which is an MRI, will be covered by the study and done at month 3 and 6.

A Phase II Open-label Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBLHCV1) Combined With an HCV Protease Inhibitor in Hepatitis C Infected Patients Undergoing Liver Transplantation

Bijan Eghtesad, MD

For patients scheduled to undergo a liver transplant for chronic hepatitis C virus (HCV) infection. The purpose of this study is to find out if treatment with the antibody MBL-HCV1 in combination with the protease inhibitor telaprevir can prevent HCV infection of your new liver. Patient participation will last up to 98 days and may last up to 140 days depending on test results.

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email

Get Involved!

For more information, call 216.636.5340 or email DDI-Research@ccf.org.

Pelvic Floor Dysfunction Database

2007

The purpose of this database is to collect medical, surgical, demographic and quality of life information on patients that are seen at the Cleveland Clinic, Department of Colorectal Surgery for a diagnosis of pelvic floor dysfunction. This would include multiple diagnoses that had to do with Pelvic Floor Dysfunction. This would include, Fecal Incontinence, Rectal Prolapse, and Constipation.

Colon and Rectal Cancer Database

1998

The purpose of this database is to collect pre-op symptoms, diagnosis, surgery, pathology reports, QOL, treatment and recurrence of patients diagnosed with Colon and/or Rectal Cancer. Patients are also asked to consent to tissue and blood banking.

Laparoscopic Database

1991

The Laparoscopic Colorectal Surgery Database is a database designed to capture the quality of life data of patients undergoing laparoscopic surgery. The Laparoscopic database collects data on demographics, surgical treatments, and preoperative and postoperative quality of life questionnaires.

Pelvic Pouch Database

The purpose of this database is the collection and storage of medical, surgical, demographic and quality of life information gathered from patients at the Cleveland Clinic who are undergoing Pelvic Pouch surgery to assess short and long term quality of life, health and functional status of these patients. Data is collected through a series of preoperative and postoperative questionnaires as well as chart review.

Diverticular Database

2004

The purpose of the registry is to better understand diverticular disease, how patients with diverticulitis manage the disease through surgery, and how diverticular disease impacts a patient's quality of life. We collect medical, surgical, demographic and quality of life information for a year.

Ripka Family Database for Crohn’s Disease Research

The purpose of this database is to collect medical, surgical, demographic and quality of life data on patients with Crohn's disease and to research into the cure and reasons for relapses of the disease. All patients with a diagnosis of Crohn's will be asked to participate in this long-term research.

Familial Adenomatous Polyposis Database

The David G. Jagelman Inherited Colon Cancer registries goal is to prevent death by providing the best care to patients and families, to promote knowledge of the risk and implications of a family history of colorectal cancer, and to produce important research in areas of concern. Data is collected from electronic, paper or outside medical records and entered into an password secured database.

Colonoscopy Database

The Colonoscopy database is a collection of medical, demographic and procedural data extracted during the colonoscopy procedure.

Familial Pancreatic Cancer Surveillance Registry

The main purpose of this registry will be to gain a better understanding of the outcomes of patients who undergo familial pancreatic cancer (FPC) surveillance. We collect clinical, endoscopic, and histological data (obtained for purposes of clinical care) on patients evaluated for FPC surveillance in a prospective registry.

HALO Patient Registry: Ablation of Barrett’s Esophagus

The research study is open to persons which have been diagnosed with Barrett’s esophagus, a pre-cancerous change to the lining of the esophagus due to acid reflux. Participants will be asked to undergo an endoscopy to evaluate the lining of the esophagus. (This is done by passing a flexible tube with a camera down a patient’s throat, while she or he is under sedation.) Areas that show evidence of Barrett’s esophagus and dysplasia will be treated with the HALO device during the endoscopy procedure. Patients will be asked to return to the Cleveland Clinic every 2 months for follow-up endoscopies, to allow the physician to monitor healing in the esophagus. Once a biopsy sample confirms that the Barrett’s esophagus has been eliminated, patients will have yearly visits that will include endoscopy (with biopsy) for surveillance. This study is open to persons who are 18 years of age and older, and who are able to give informed consent. This study is also open to patients who have been previously treated with the HALO device for Barrett’s esophagus.

Cleveland Clinic Barrett’s Esophagitis Registry

The registry has two primary roles. The registry has a clinical service role as it is utilized to generate patient reminder letters for surveillance procedures. It also serves as a potential source of patients for all Barrett's esophagus research at the Cleveland Clinic. All patients are entered into the registry based on the information derived from a data sheet which is completed at the time of the endoscopic procedure.

The Cleveland Clinic Foundation Inflammatory Bowel Disease DNA Bank

The purpose of this database is to study the genetics that cause Crohn’s disease and ulcerative colitis. Patients and a significant other are asked to donate 2 tubes of blood and answer a brief questionnaire.

Adenoma Registry

1987

The purpose of the registry is to collect patient information and procedural and pathologic results of lower endoscopic procedures done on Cleveland Clinic Foundation patients. This data can be used to address risk factors for colorectal neoplasia, proper surveillance intervals and is used to send a recall letter to patients to advise them when they are due for their next colonoscopy according to national guidelines.

Laparoendoscopic Treatment of Gastric Stromal Tumors

The purpose of this database is to collect data on patients presenting with gastric stromal tumors that have surgical intervention with a laparoendoscopic procedure.
The data is collected from the electronic chart and hard copy medical records. Information regarding symptoms, diagnostic work up, post operative surgical course and follow up contact regarding symptoms and surveillance is collected.

Pancreatic Cystic Neoplasm

This purpose of this database is to identify trends in patients presenting with pancreatic cysts and looking at standard of care testing for diagnosis and treatment.. A mail out letter and phone script are used to follow up with patients inquiring on symptoms and continued surveillance of pancreatic cysts by CT scan.

Comprehensive Liver Cancer Database

The purpose of this database is to collect medical, surgical, non-surgical treatments and surgical and non-surgical outcomes of patients with primary liver cancer.

Liver Donor/Recipient Outcomes Database

To have an organized method to access the outcomes and characteristics of liver transplant patients. This database will allow the filtering of data to answer a particular question, review the data for quality management, and observe trends including survival curves based on, for example, recipient diagnosis, MELD score at the time of transplant, etc.

For more information about enrolling studies, databases and registries in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Why Participate?

Patients taking part in DDI clinical research studies at Cleveland Clinic are seen by a team of expert doctors, nurses, technicians, and support staff. Clinical research patients often are first to receive promising new treatments before they become available in the community.

Patients are helping others with the same disease, both today and in the future.

What are the Risks and Benefits?

It is important to understand that some risks are involved in clinical research, just as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time.

Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study.

Before deciding to participate, you should carefully weigh these risks against possible benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge developed may help others.

What is the “informed consent process”?

Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.

Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information.

The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract.

Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.

Who supports clinical research studies?

Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs. Trials can occur at sites as varied as hospitals, universities, doctors’ offices, or community clinics.

How are studies designed?

Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:

  • Who is eligible to participate in the trial
  • Details about tests, procedures, medications, and dosages
  • The length of the study and what information will be gathered

A clinical study is led by a principal investigator, who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

What Are the Main Types of Clinical Trials?

Clinical trials are conducted in "phases." The trials at each phase have a different purpose and help researchers answer different questions.

Phase I trials—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.

Phase II trials—The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.

Phase III trials—The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials—After a drug is licensed (approved by the FDA) or treatment is launched, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use. These long–term studies involving large groups of participants continue to see if any unexpected side effects occur in a small percentage of individuals.

What happens when a clinical research study is over?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

What should I consider when deciding to participate?

It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Digestive Disease Clinical Research personnel.

Be sure you know the answers to the following questions before you make your decision:

  • What is the purpose of the study?
  • What is required of me?
  • What is my role in the study—am I a healthy volunteer or a patient volunteer?
  • Will the study directly benefit me?
  • Will the study benefit others?
  • Are there risks? If so, what are they and what are the chances that they will occur?
  • What discomforts are involved?
  • What is the total time involved?
  • Are there other inconveniences?
  • Have I discussed participation in the study with those who are important to me, such as family and friends?
  • Do I wish to participate in this study?

Clinical research is medical research that involves people. Individuals volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose and understand human disease. There are strict rules for clinical research, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.

Clinical research studies can be a means of developing new treatments and medications for diseases and conditions or a way to track information about medical conditions over time.

Ideas for clinical research often originate in the laboratory or patient-care settings. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

Clinical research studies in the Digestive Disease Institute fall into two basic types of projects. The first type is clinical trials. In clinical trials, a new drug or device is often being evaluated. Some clinical trials involve promising new treatments that may directly benefit patients.

The second type is an outcomes research database or registry. In a research database, information about an individual and his/her health is collected over a period of time. Research databases may indirectly benefit patients as trends about health conditions and best treatment options are identified.

"Improving Lives One Study at A Time"

The Digestive Disease Clinical Research Unit (DDCRU) facilitates clinical research activity for the following clinical disciplines: Colorectal Surgery, Gastroenterology and Hepatology, Liver Transplant, Hepatobiliary, Enterostomal Therapy and Nutrition. The DDCRU is an integrated multidisciplinary team of over 40 clinical research personnel.

With experience in surgical and medical clinical trials as well as database and epidemiological studies, the DDCRU offers diverse expertise within the field of clinical research.

The clinical trials branch of the Digestive Disease Clinical Research Unit are project team based, allowing studies to be conducted by a subset of research personnel with specific expertise.

Currently in the DDCRU, our clinical trials project teams are:

In addition to experience with various types of clinical research, the DDCRU facilitates budget and contract negotiation and institutional and federal regulatory compliance.

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

For more information about Digestive Disease Institute’s clinical research studies, please contact us:

216.636.5340

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This information is provided by Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition.

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