COMMUNITY RESEARCH DEVELOPS ADVISORY BOARD
Leading sleep medicine researcher named first advisor

(CINCINNATI, OH)-Community Research, one of the tri-state's largest clinical research facilities, has created an advisory board to offer insight on regulatory matters and to provide input from valued advisors in their field of expertise. The company has named Dr. Thomas Roth, an internationally-known expert in sleep medicine studies and Director of Research and Chief of Sleep Medicine at Henry Ford Hospital in Detroit, Michigan, as the first member of the Advisory Board.

"We're thrilled and honored to welcome Dr. Roth as the first member of our advisory board," said Dr. David Mayleben, President and Co-Founder of Community Research. "Tom's extensive regulatory and clinical research knowledge, along with his renowned expertise in the area of sleep research, makes him an ideal advisor to our organization."

Dr. Roth is one of the leading authorities on sleep and sleep medicine in the world and has been involved in a variety of aspects in drug development ranging from evaluation of potential compounds to regulatory affairs. In addition to his position at Henry Ford Hospital, he is also a Clinical Professor in the Department of Psychiatry at that University of Michigan College of Medicine. Dr. Roth is past President of the National Sleep Foundation, the former Chair of the National Center of Sleep Disorders Research of the National Institutes of Health (NIH) as well as the former Chairman of the World Health Organization (WHO).

Dr. Roth commented, "I look forward to assisting in the development of a solid academic advisory board that will help assure Community Research a strong leadership position in all aspects of drug development from first-in-man initiatives through phase IV trials."

Community Research plans to name three to five experts to its Advisory Board to offer guidance on the organization's growth strategy.

Community Research is a dedicated clinical research site that offers a full spectrum of Phase 1 clinical trial services: BA/BE, PK/PD, SAD, MAD, and First-in-Man. They also offer some unique capabilities including sleep laboratory and human performance studies and dental/oral care studies using a full suite of dental equipment. Phase 1 capacity is currently set at 44 beds, with expansion to 60 beds in the planning stage. In addition to Phase 1 clinical trial work, Community Research conducts Phase 2 - 4 clinical studies across a wide range of therapeutic indications at three other locations in the Greater Cincinnati area.

Community Research was recognized as a 2010 Blue Ribbon Business by the US Chamber of Commerce and one of the 60 TOP WORK PLACES 2010 in Cincinnati by Cincinnati Enquirer Media.

FACTS

• Currently there are approximately 50,000 clinical trials taking place in the United States, 80% are delayed at least one month because of unfulfilled enrollment. (Source: CenterWatch)
• One out of every four volunteers drops out of a study after they have begun participation. (Source: CenterWatch)
• In the 1960s it took 8.1 years to develop a new drug-in the 1990s it took researchers 15.3 years, or nearly double the time. (Association of Clinical Research Professionals)
• From 2001 to 2004 the number of people who stated that they had the opportunity to participate in a clinical research study increased by almost 50% from 13% to 19% (Harris Interactive, May 2004)
• Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 35% of participants in cancer clinical trials. (Journal of Clinical Oncology, 2003)
• One in 8 physicians (13%) currently serve as a clinical investigator (Harris Interactive, May 2004)
• In 2001, there were 402 different drugs in cancer trials, according to a survey on new medicines in development for cancer, published by the Pharmaceutical Research and Manufacturers of America (PhRMA)
• Eighty-seven percent of physicians are not involved in clinical trials - 38% attribute lack of opportunity as the main reason for not serving as a Principal or Sub Investigator in a clinical trial and 32 % feel that the time commitment is too much (Harris Interactive, May 2004)

Public Perception

• The major reasons cited by patients for participating in clinical trials include "If it would benefit me or someone else" (58%). "If I knew all about the risks" was second (48%); "If the risk was minimal or if the reward outweighs the risk" was third (35.3%); For a cure" was fourth (35.2%); and "If my doctor recommended it" was fifth (34.5%) (Source: Harris Interactive)
• An overwhelming majority of people (77%), say that they would consider getting involved in an appropriate clinical research study if asked; only 10% of those eligible to participate in clinical trials do so in the United States. (Source: Harris Interactive)
• Very few patients are even aware that they are eligible to participate. And surprisingly, only 30% of participants report that they first learned about a clinical trial from their primary/specialty health care provider. (Source: Institute of Medicine)
• In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process. (Source: CenterWatch)

Adverse Events

• Each year, 17,200 adverse events (AEs) and 800 serious adverse event (SAEs) are typically reported to the FDA for newly approved drugs (Source: Food & Drug Administration)
• Each year, an average of 3.6 deaths attributed to study drug effects are reported to the FDA. (Source: Food & Drug Administration)
• One adverse event per study subject per New Drug Application (NDA) is typically reported to the FDA. (Source: Food & Drug Administration)
• On average, one out of every 30 study subjects per NDA will have a serious adverse event. (Source: Food & Drug Administration)
• In reports from industry to the FDA, one out of 10,000 study subjects have died as a result of study drug effects while participating in clinical research studies. This compares to 1 in 3,000 people who die from an accidental injury each year, and 1 out of every 6,000 people who die from a motor vehicle accident annually. (Source: Food & Drug Administration)

Minority Populations

• African-American, Hispanic and Asian trial participants represent over 1/3 of our population, yet in 1999 only 6% African-Americans, 1% Asians and 1% Hispanics, for a total of 8%, participated in trial; down from 12% in 1995. This situation is on great concern because the information we get from clinical trials is of greater value when trial participants more closely represent our population. (Source: First Clinical Research)
• The National Institutes of Health (NIH) first published guidelines in 1987 for including more minorities in government-funded clinical studies, but these guidelines do not apply to industry-funded research. (First Clinical Research)
• In 1996, black patients represented 11% of all cancer trial participants, by 2002 that number declined to 7.9 percent. Hispanics -- who make up 9.1% of the U.S. population -- made up 3% of participants in clinical trials in 2002, down from 3.7% in 1996. (Source: Healthday News: June, 2004)
• Approximately to 20% of all participants in drug trials are over the age of 65. (Source: AARP Bulletin Online: June, 2003)

Treatment & Cures of Diseases

• There are currently 122 new medicines in development to treat heart disease and stroke, two of the top three causes of death in the United States. (Source: Pharmaceutical Research and Manufacturers of America)
• Less than 5% of cancer patients participate in clinical trials. If 10% participated, studies could be completed in one year, instead of the three-five years that studies currently require. (Source: National Cancer Institute)
• The five year survival rates for cancer patients has increased to 64% from 59% just ten years ago. (National Cancer Institute and Centers for Disease Control and Prevention)

An Introduction to Clinical Trials

 What is a clinical trial?

A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

 Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

 Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

 What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

 What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

 What are the benefits and risks of participating in a clinical trial?

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Help others by contributing to medical research.

There are also risks to clinical trials:

• There may be unpleasant, serious or even life-threatening side effects to treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

 What are side effects and adverse reactions?

Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

 How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).

 What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

 What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

• Plan ahead and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

 Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

 Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

 Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

 Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

 What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

 What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

 What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

 What are the different types of clinical trials?

• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

 What are the phases of clinical trials?

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

• In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

 What is an "expanded access" protocol?

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess safety and efficacy of new drugs. Data from the trials can serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these carefully-controlled trials because of other health problems, age, or other factors. For patients who may benefit from the drug use but don't qualify for the trials, FDA regulations enable manufacturers of investigational new drugs to provide for "expanded access" use of the drug. For example, a treatment IND (Investigational New Drug application) or treatment protocol is a relatively unrestricted study. The primary intent of a treatment IND/protocol is to provide for access to the new drug for people with a life-threatening or serious disease for which there is no good alternative treatment. A secondary purpose for a treatment IND/protocol is to generate additional information about the drug, especially its safety. Expanded access protocols can be undertaken only if clinical investigators are actively studying the new treatment in well-controlled studies, or all studies have been completed. There must be evidence that the drug may be an effective treatment in patients like those to be treated under the protocol. The drug cannot expose patients to unreasonable risks given the severity of the disease to be treated.

Some investigational drugs are available from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. Expanded access protocols are generally managed by the manufacturer, with the investigational treatment administered by researchers or doctors in office-based practice. If you or a loved one are interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and location information and inquire at the Contact Information number.

The above information is provided by www.clinicaltrials.gov, a service of the National Institute of Health. It was last updated: 30 June 2003.