www.archive.org
`415.561.6767
`415.840-0391 e-fax
`
`T ntcrnct Archive
`300 Funston Avenue
`San Francisco, CA 94118
`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`1. I am the Office Manager at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions, including the
`Library of Congress.
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 450 billion pages stored in the
`Internet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (i.e., a website address). If archived records for a URL are available, the visitor
`will be presented with a list of available dates. The visitor may select one of those
`dates, and then begin surfing on an archived version of the Web. The links on the
`archived files, when served by the Wayback Machine, point to other archived files
`(whether HTML pages or images). If a visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browseable by the Wayback Machine is
`compiled using software programs known as crawlers, which surf the Web and
`automatically store copies of web files, preserving these files as they exist at the point of
`time of capture.
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL]. Thus, the Internet Archive URL
`http://web.archive.org/web/19970126045828/http://www.archive.org! would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28 seconds
`(1997/01126 at 04:58:28). A web browser may be set such that a printout from it will
`display the URL of a web page in the printout's footer. The date assigned by the Internet
`Archive applies to the HTML file but not to image files linked therein. Thus images that
`appear on a page may not have been archived on the same date as the HTML file.
`Likewise, if a website is designed with "frames," the date assigned by the Internet
`Archive applies to the frameset as a whole, and not the individual pages within each
`frame.
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`Internet Archive's records of the HTML files for the URLs and the dates specified in the
`footer of the printout.
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: J1.. ll--{ [ c,.
`
`Christopher Butler
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0001
`
`

`
`CALIFORNIA JURAT
`
`See Attached Document.
`
`State of California
`County of San Francisco
`
`A notary public or other officer completing this
`certificate verifies only the identity of the
`individual who signed the document to which this
`certificate is attached, and not the truthfulness,
`accuracy, or validity of that document.
`
`Subscribed and sworn to (or affirmed) before me on
`this
`
`r:::;;J4 -=-~KVLE riE\IJN~e;G1
`,.;.
`.>'
`'''''', >( ~
`COMM # 2067666
`SAN FRANCiSCO COUNTY ~
`NOT.A,RY PUBLIC-CALIFORNiA Z
`MY COMMISSION
`MAY 10, 20
`
`Christopher Butler,
`
`proved to me on the basis of satisfactory evidence to be
`the person who appeared befo
`
`~ IIO\II'Y public Of oilier offK:er completing this certificate verifieS only the identity of the
`incIMduaI who signed the document to which this certificate is ~, and not the
`lnIIhfuIness,aceuracy, orvalidityoflhat documenl
`.
`STATE OFCAl.lFORNIA COUNTY Of ________ _
`SuflacribedandlMllRlo(or alinned)belalemeonlllis _ _ dayof ___ _
`2O_by
`,
`
`proved to me on the basis of satisfactory evidence 10 be the person(s) who appeared
`before me,
`
`(Signature of Notary)
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0002
`
`

`
`Exhibit A
`Exhibit A
`
`Sandoz Inc. IPR2016-00318
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0003
`Sandoz V. Eli Lilly, Exhibit 1082-0003
`
`

`
`Lilly Clinical Trials
`
`10f3
`
`Lilly Clinical Trials
`
`Frequently
`Asked
`Questions
`
`What is a
`clinical trial?
`
`What are the
`risks associated
`with clinical
`trials?
`
`What are the
`benefits of
`participating in
`a clinical trial?
`
`What does it
`cost?
`
`How do I find
`out about trials?
`
`What questions
`should I ask?
`
`What is a clinical trial?
`
`A clinical trial is a well-controlled research study testing a new investigational medication or
`therapy in humans. Before a clinical trial can begin, the FDA (Food and Drug Administration) must
`approve the use of the new drug for testing in humans. Clinical trials, required for all new drugs
`before they can be released for use in the general public, are generally organized into four phases:
`Phase I, II, III, and IV. You should understand which phase of testing the new drug therapy is in
`when you consider volunteering for a clinical trial.
`
`Phase I A Phase I clinical trial is the first step in testing a new investigational medication in
`humans. Phase I studies are mainly concemed with how the drug is absorbed and broken down by
`the body. These studies help determine the best way to give a drug to a patient (for example by
`mouth, or by injection), and what side effects may be likely. Except for drugs used to treat cancer,
`Phase I clinical trials are usually conducted in healthy individuals and are not intended to treat
`disease or illness. Because cancer can be such a life-threatening condition, Phase I trials with
`anti-cancer drugs are usually carried out in patients who already have the disease.
`
`Phase II Phase II clinical trials may involve up to several hundred volunteers who have the
`disease state or condition to be treated. These trials may last one to two years as physicians and
`researchers begin to leam more about the safety of the new drug treatment and how well it treats
`the disease or condition. Several different doses of the drug may be looked at to see which dose
`has the desired effects. Patients are watched for side effects and for any improvement in their
`illness, symptoms, or both.
`
`Phase III After a drug has been shown to have positive results in small groups of patients, it may
`be studied in a larger Phase III trial. A Phase III trial usually compares how well the new drug
`works with a drug that has already been approved and has been used to treat the disease
`condition. One group of patients may receive the new drug being tested, while another group of
`patients may receive the comparator drug (already-approved drug for the disease being studied).
`And in some Phase III studies testing drugs that are not for life-threatening illness such as cancer,
`a third group of patients may receive a placebo "sugar pill". Patients in phase III trials generally do
`not know which drug they are getting, and in many cases, neither do the doctors. This is
`commonly referred to as a "blinded" study and this is done to make a fair evaluation in how well
`the new drug therapy works.
`
`Phase IV Phase IV clinical trials are sometimes called "post-marketing" trials because these
`studies begin after the Phase I - III study results have been given to the FDA for approval. These
`studies usually enroll several hundred to several thousand patients and may be done to determine
`if the drug is effective against other disease states, or to test different ways of taking the drug such
`as tablets, time-release capsules or syrups.
`
`What are the risks associated with clinical trials?
`
`Although a lot of research has been performed on each drug before it is given to humans, it is
`important to remember that clinical trials are conducted to leam more about how the drug will act
`in the human body. Clinical trials can help to determine if there are any side effects and if so, what
`to expect. The amount of risk depends on the type of study. Your physician will take the time to
`explain the potential risks with you, and will ask a lot of questions about your medical history to
`help reduce the risks. You have the right to receive answers to any questions you may have about
`volunteering for a clinical trial. To help you talk over any concerns with your physician, we have
`prepared a list of questions to ask, below.
`
`What are the benefits of participating in a clinical trial?
`
`https:llweb.archive.org/web/200ll 028234 7lllhttp://www.lillytrials.com/faq .shtml
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0004
`
`

`
`Lilly Clinical Trials
`
`20f3
`
`The decision to participate in a clinical trial is a personal one that mayor may not include any
`direct benefits to you. Some of the potential benefits may include the opportunity to:
`
`• Receive a new drug therapy that is not currently available.
`• Receive professional medical care and free study medication for a disease condition you
`might already have.
`• Contribute to society by helping investigate treatment options for a disease or illness.
`• Receive compensation for your participation in the trial.
`
`What does it cost?
`
`There should be no cost to participate in a clinical trial and study medication is free of charge.
`
`How do I find out about trials?
`
`• Check your local newspaper for advertisements of clinical trial studies being done in your
`area.
`• There are many World Wide Web sites on the Internet listing clinical trials that are looking
`for volunteers. You can do your own search by logging onto a search engine such as
`www.yahoo.com , www.altavista.com , or www.netscape.com , and include key words such as
`clinical trials or clinical research.
`• Your physician or healthcare professional.
`• Hospitals and Local Universities.
`• Disease Associations such as the American Cancer Society, (check your phone directory
`for local chapters).
`
`What questions should I ask?
`
`You have the right to receive answers to any questions you may have about volunteering for a
`clinical trial. There are no wrong questions. Listed below are some sample questions to help you
`talk over your concerns with a physician or healthcare professional:
`
`• Why is this study being conducted? What are the goals of the study?
`• What are my risks in participating in this trial?
`• How will my participation be kept private?
`• Will my study results be shared with anyone?
`• How much time involvement will this require?
`• Will I be asked to drive to a health clinic or hospital? How often?
`• What about childcare arrangements during health clinic or hospital visits?
`• What if I want to stop participating on this trial?
`• Will I know what drug treatment, if any, I will be receiving?
`• What if I feel ill when I am at home?
`• Can I still take my birth control pills?
`• Can I still take my other medications?
`• What if I become pregnant?
`• What happens if I am harmed by the drug treatment?
`• How do the side effects of the new drug therapy differ from the standard treatments?
`• Has this treatment ever been tested in humans?
`• What if the test drug doesn't work and I am still sick?
`• Who is in charge of my care?
`• How can I reach a healthcare professional when I am at home?
`• If I benefit from the new drug treatment, can I continue to receive the medication after the
`study is ended?
`• Who is paying for the study? Will I receive any money for parking, etc.?
`• Will I receive any money for participating in the trial? How much?
`• Where does my medical insurance provider fit into this study?
`• Will the study results be communicated to me? When?
`
`https:llweb.archive.org/web/200ll 028234 7lllhttp://www.lillytrials.com/faq .shtml
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0005
`
`

`
`Lilly Clinical Trials
`
`30f3
`
`https:llweb.archive.org/web/200ll 028234 7lllhttp://www.lillytrials.com/faq .shtml
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0006
`
`

`
`Lilly Clinical Trials
`
`lof2
`
`Lilly Clinical Trials
`
`8 1.§. IQ I QI s I.E I § I t! I ! 11 1!S I b 1M I t::! I Q I E I Q I E I § I 1 111 I ~ I ~ 12$ I Y I ~
`L
`
`Labeling
`All labels and other written, printed or graphic matter upon any article or any of its
`containers or wrappers, or accompanying such article.
`
`8 1.§. IQ I QI s I.E I § I t! I ! 11 1!S I b 1M I t::! I Q I E I Q I E I § I 1 111 I ~ I ~ 12$ I Y I ~
`M
`
`Marketed drug
`A drug product for which marketing authorization has been granted.
`
`Multicenter trial
`A clinical trial conducted according to a single protocol but at more than one site, and
`therefore, carried out by more than one investigator.
`
`N
`
`No definitions
`
`8 1.§. IQ I QI s I.E I § I t! I ! 11 1!S I b 1M I t::! I Q I E I Q I E I § I 1 111 I ~ I ~ 12$ I Y I ~
`o
`
`Open-label study
`A study in which the investigator and the study participant are aware of the drug therapy
`received during the study.
`
`p
`
`Patient
`A study participant who has the disease or condition for which the investigational product is
`targeted.
`
`Patient files
`Hospital files, consultation records, or special patient files that are maintained and kept at
`the study site.
`
`Phase (in relation to drug development)
`Drug development is divided in phases that are determined by the main objectives of the
`drug development process .
`
`• Phase I A Phase I clinical trial is the first step in testing a new investigational
`medication in humans. Phase I studies are mainly concerned with how the drug is
`absorbed and broken down by the body. These studies help determine the best way
`to give a drug to a patient (for example by mouth, or by injection), and what side
`effects may be likely. Except for drugs used to treat cancer, Phase I clinical trials are
`
`https:llweb.archive.org/web/20020219135226/http://www.lillytrials.com/glossaryL_P.shtml
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0007
`
`

`
`Lilly Clinical Trials
`
`20f2
`
`usually conducted in healthy individuals and are not intended to treat disease or
`illness. Because cancer can be such a life-threatening condition, Phase I trials with
`anti-cancer drugs are usually carried out in patients who already have the disease.
`• Phase II Phase II clinical trials may involve up to several hundred volunteers who
`have the disease state or condition to be treated. These trials may last one to two
`years as physicians and researchers begin to learn more about the safety of the new
`drug treatment and how well it treats the disease or condition. Several different doses
`of the drug may be looked at to see which dose has the desired effects. Patients are
`watched for side effects and for any improvement in their illness, symptoms, or both.
`• Phase III After a drug has been shown to have positive results in small groups of
`patients, it may be studied in a larger Phase III trial. A Phase III trial usually
`compares how well the new drug works with a drug that has already been approved
`and has been used to treat the disease condition. One group of patients may receive
`the new drug being tested, while another group of patients may receive the
`comparator drug (already-approved drug for the disease being studied). And in some
`Phase III studies testing drugs that are not for life-threatening illness such as cancer,
`a third group of patients may receive a placebo "sugar pill". Patients in phase III trials
`generally do not know which drug they are getting, and in many cases, neither do the
`doctors. This is commonly referred to as a "blinded" study and this is done to make a
`fair evaluation in how well the new drug therapy works.
`• Phase IV Phase IV clinical trials are sometimes called "post-marketing" trials
`because these studies begin after the Phase I - III study results have been given to
`the FDA for approval. These studies usually enroll several hundred to several
`thousand patients and may be done to determine if the drug is effective against other
`disease states, or to test different ways of taking the drug such as tablets,
`time-release capsules or syrups.
`
`Placebo
`An inactive substance used in controlled studies. The placebo may be used in screening or
`washout periods or used as a comparator to determine the efficacy of medical substances.
`
`Protocol
`An action plan for a clinical trial. The plan states what will be done in the study and why. It
`outlines how many people will take part in the study, what types of patients may take part,
`what tests they will receive and how often, and the treatment plan.
`
`8 1 §. IQ I Q I £ I.E I Q I ti l ! 11 I.!S I 1, 1M I t::! I Q I E I Q I E I § I I 111 I ~ I ~ 12S I ::r: I ?;
`
`This site is intended for US Residents only.
`Copyright 2001, Eli Lilly and Company. All rights reserved.
`
`https:llweb.archive.org/web/20020219135226/http://www.lillytrials.com/glossaryL_P.shtml
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0008
`
`

`
`Lilly Clinical Trial Registry - Terminology
`
`I of 4
`
`Terminology
`
`A I B I C I D I E I F I G I H l l l J I K I L I M I N I O I P I Q I R I S I T l u l V I W I X I Y I Z
`
`Adverse Event (AE): An unfavorable or unintended sign, symptom, reaction, or disease that is associated in time
`with the use of an investigational drug, whether or not the event is related to the investigational drug, or is expected.
`
`Adverse Event, Serious (SAE) or Adverse Drug Reaction, Serious (Serious ADR): An adverse event that at any
`dose of the drug meets one of the following conditions:
`
`• Results in death, or
`• Is life-threatening, or
`• Requires inpatient hospitalization or prolongation of existing hospitalization, or
`• Results in persistent or significant disability/incapacity, or
`• Is a congenital anomaly/birth defect
`
`Advertisement: In clinical trials, recruitment advertisements are any materials used for recruitment of study
`participants (for example, letters, bulletin board notices, and notices in newspapers, or on radio, television, or the
`internet).
`
`Blinding: A procedure in which one or more parties to the clinical trial (i.e., the subject/patient, investigator, and/or
`sponsor medical personnel) are kept unaware of the treatment assignment(s) of the clinical trial participants. Used to
`remove potential for study bias.
`
`back to top
`
`Clinical Trial/Study: Any investigation in humans intended to discover or verify the effects of an investigational drug
`or new use of an already marketed drug, and/or to identify any adverse reactions to the investigational drug with the
`object of determining safety and/or efficacy of the studied use. The terms "clinical trial" and "clinical study" are
`synonymous.
`
`Clinical Trial Data: All collected information arising from patients entering a clinical trial.
`
`Clinical Trial Material: The testing material used in a clinical trial, including the primary study drug, comparator
`drugs, and placebo as specified in the study protocol. Clinical trial material includes any investigational product,
`including medical devices, designed for human use.
`
`Clinical Trial Material Package Lot Number: An identification number associated with clinical trial material that
`identifies a batch of clinical trial material and from which the production and distribution history can be determined.
`
`Comparative Study: A study in which a participant is randomly assigned to one of two or more treatment groups for
`purposes of comparing the results of the separate treatment groups.
`
`Comparator Drug: An investigational or marketed drug (i.e., active control) or placebo used as a reference in a
`clinical trial.
`
`Completed Study: For this registry, a study is considered completed on the date of the last patient visit (of the
`patients enrolled in that study) by an investigator authorized to conduct the study by the sponsor and the IRB/ERB.
`
`Confidential Information : Information not in the public domain that is private to the study participant (such as
`identity or personally identifiable health information), or that is proprietary to the sponsor (such as intellectual property
`and some study designs and endpoints).
`
`Core Registration Studies: Those primary safety and efficacy studies that the relevant government health agency
`uses to decide whether or not to approve the investigational drug or new use of a marketed drug. These studies are
`usually phase 3, always well controlled, randomized, of adequate size and, whenever possible, double blind. May
`also be called Pivotal or Confirmatory Trials.
`
`back to top
`
`Documentation: All records, in any form (including without limitation written, electronic, magnetic, and optical
`records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a
`trial, the factors affecting a trial, and the actions taken or omitted.
`
`Dosing Regimen: The expected amount of study medication prescribed per time unit and duration of dosing (for
`example, 3 times/day for 7 days of therapy) as required in the study protocol.
`
`Double-Blind Study: A clinical trial in which neither the investigator nor the study participant is aware of the
`treatment received.
`
`Drug: Any recognized chemical compound that may be used on or administered to humans or animals as an aid in
`the diagnosis, treatment, or prevention of disease or other abnormal condition.
`
`back to top
`
`Efficacy: The ability to produce a desired favorable effect in treating or preventing the studied disease or condition.
`
`Enroll: The point at which a study participant is assigned to a study treatment in a clinical trial.
`
`Enter: The act of obtaining informed consent for participation in a clinical study from participants deemed potentially
`
`https:llweb.archive.org/web/20060206195352/http://www.lillytrials.com/docs/terminology.html
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0009
`
`

`
`Lilly Clinical Trial Registry - Terminology
`
`20f4
`
`eligible to participate in the clinical study.
`
`back to top
`
`Food and Drug Administration (FDA): A branch of the U.S. Department of Health and Human Services primarily
`responsible for regulating the approval and use of drugs, medical devices, cosmetics, and foods.
`
`Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording,
`analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and
`accurate, and that the rights, integrity, and confidentiality of trial participants are respected and protected.
`
`Healthcare Professionals: Medical practitioners, pharmacists, dentists, nurses, and other individuals authorized to
`administer or dispense pharmaceutical products.
`
`Hypothesis: A scientific idea about how something works, before the idea has been tested. Scientists do
`experiments to test a hypothesis and see if the hypothesis is correct.
`
`back to top
`
`Indication: The efficacy claims that are approved by the relevant government health agency for the medicine on the
`basis of the Core (Pivotal) Registration Studies. The indication is contained in the product label, also called
`prescribing information. The indications for a product may (and often do) differ by geography and country.
`
`Informed Consent: A process by which a participant voluntarily confirms his or her willingness to participate in a
`particular clinical trial, after having been informed of all aspects of the trial relevant to the participant's decision to
`participate, including known and potential risks and benefits. Informed consent is documented by means of a written,
`signed and dated informed consent form.
`
`Initiated Trial: See Study Start Date .
`
`Institution (Medical): Any public or private entity or agency, or medical or dental facility, where clinical trials are
`conducted.
`
`Institutional Review Board, or IRB: Also known in some countries as Ethics Review Board, or ERB. This is the
`scientific institution that is independent of the sponsor of the clinical trial that reviews and approves the study protocol
`on ethical treatment grounds and ensures that each participant enrolled in the trial has given their informed consent
`to participate. The IRB or ERB monitors the clinical trial from inception through completion.
`
`Investigational Drug: An active drug that is being studied in a clinical trial.
`
`Investigational New Drug Application (IN D): After completing preclinical testing, a company files an IND with the
`U.S. Food and Drug Administration to begin to test the drug in humans. The IND becomes effective if FDA does not
`disapprove it within 30 days. The IND shows results of previous experiments; how, where and by whom the new
`studies will be conducted; the chemical structure of the investigational drug; how it is thought to work in the human
`body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical trials must be
`reviewed and approved by the Institutional Review Board (IRB) where the trials will be conducted (in Europe, the
`Ethics Review Board, or ERB).
`
`Investigator: A health care professional responsible for the conduct of a clinical trial at a trial site and who
`coordinates with the study sponsor and the IRB. If a trial is conducted by a team of individuals at a trial site , the
`investigator is the responsible leader of the team and may be called the principal investigator.
`
`back to top
`
`Labeling: All labels and other written, printed or graphic matter on a medication or any of the medication's containers
`or wrappers, or that accompany the medication, such as the prescribing information . The labeling of a medication
`includes a description of the uses for which the medication has been approved by the government for the geography
`where the drug will be marketed.
`
`Last Patient Visit: The "Last Patient Visit" is considered the last study visit of the last patient remaining in the trial,
`anywhere in the world.
`
`Marketed Drug: A drug product for which marketing authorization has been granted in at least one indication in a
`particular country by a government health agency. Once initial marketing approval is obtained, subsequent research
`may be ongoing for additional indications or formulations or as part of required safety follow up.
`
`Methodology: The way in which information is found or something is done. The methodology includes the methods,
`procedures, and techniques used to collect and analyze information.
`
`Multicenter Trial: A clinical trial conducted according to a single study protocol and identical methods at more than
`one investigative site, and therefore, carried out by more than one investigator.
`
`New Drug Application (NDA): Following the completion of all three phases of clinical trial development, a company
`analyzes all of the data and files an NDA with the U.S. Food and Drug Administration if the data successfully
`demonstrate both safety and effectiveness. The NDA contains all the scientific information that the company has
`gathered on the investigational drug. NDAs typically run 100,000 pages or more and can take up to a year or longer
`to review by the FDA, on average. Once FDA approves an NDA, the new medicine becomes available for physicians
`to prescribe.
`
`Observational Study: A study in which the investigator does not manipulate the use of an intervention (e .g., do not
`randomize patients to treatment and control groups), but only observes patients who are (and sometimes patients
`who are not) exposed to the intervention, and interpret the outcomes. The investigator's decisions regarding the
`proper treatment and care of the patient are made in the course of normal clinical practice.
`
`Off-label Use : The prescribing of a medication by a physician or other healthcare provider for a use other than that
`
`https;llweb.archive.org/web/20060206195352/http://www.lillytrials.com/docs/terminology.html
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1082-0010
`
`

`
`Lilly Clinical Trial Registry - Terminology
`
`30f4
`
`which the medicine has been approved for marketing by a government health agency.
`
`Open-label Study: A study in which the investigator and the study participant are aware of the drug therapy received
`during the study.
`
`back to top
`
`Patient: A study participant who has the disease or condition for which the investigational product is being studied.
`
`Patient Files: Hospital files, consultation records, or special patient files that are maintained and kept at the study
`site. In this context, also includes Phase 1 study participants, who are typically healthy volunteers without disease.
`
`Pharmacokinetics: The actions of a drug in the human body over a period of time, including the absorption,
`distribution, metabolism, and excretion of the drug.
`
`Phase (in relation to Drug Development): Drug development is divided into phases that are determined by the main
`objectives of the drug development process.
`
`• Preclinical: Laboratory or animal studies to show biological activity of the compound against the targeted
`disease, with the compound evaluated for safety and possible formulations.
`• Phase 1 : A Phase 1 clinical trial is the first step in testing a new investigational medication (or new use of a
`marketed drug) in humans. Phase 1 studies are mainly concerned with evaluating a drug's safety profile,
`including the safe dosage range. The studies also determine how the drug is absorbed and broken down by the
`body, what is the best way to give the drug to a patient (for example by mouth, or by injection), what side effects
`may be likely, and how the drug is absorbed, distributed, metabolized, and excreted as well as its duration of
`action. Except for drugs used to treat cancer, Phase 1 clinical trials are usually conducted in healthy individuals
`and are not intended to treat disease or illness. Because cancer can be such a life-threatening condition, Phase
`1 trials with anti-cancer drugs are usually carried out in patients who already have the disease.
`• Phase 2 : Phase 2 clinical trials involve volunteers who have the disease or condition to be treated. These trials
`help physicians and researchers begin to learn more about the safety of the new drug treatment and how well
`the drug treats the targeted disease or condition . Several different doses of the drug may be looked at to see
`which dose has the desired effects. Patients are monitored for side effects and for any improvement in their
`illness, symptoms, or both.
`• Phase 3 : After a drug has been shown to have positive results in small groups of patients, it may be studied in
`a larger Phase 3 trial to confirm efficacy and identify adverse events from long-term use . A Phase 3 trial usually
`compares how well the study drug works compared with an inactive placebo and/or another approved
`medication. One group of patients may receive the new drug being tested, while another group of patients may
`receive the comparator drug (already-approved drug for the disease being studied), or placebo.
`• Phase 4 : Phase 4 clinical trials are sometimes called "post-marketing" trials because these studies begin after
`the Phase 1 - 3 study results have been given to the FDA for evaluation. These studies may be done to
`determine if the drug is effective against other disease states, or to test different ways of taking the drug such
`as tablets, time-release capsules or syrups, or to look for adverse events in larger populations over longer
`periods of time.
`Placebo: An inactive substance or "sugar pill" used in comparative studies. The placebo may be used in screening or
`washout periods or used as a comparator to determine the efficacy of a medication.
`
`Primary and Secondary outcome measures: The measures collected in a clinical trial that are intended to answer
`the primary and secondary objectives of the trial.
`
`Principles of Medical Research
`
`1. Lilly sponsors and supports medical research for the purpose of answering scientific questions that are
`important and relevant to its customers.
`2. Lilly makes payments to health care providers only for legitimate, reasonable and necessary services and in
`amounts that are no more than the fair market value for the services performed.
`3. Lilly discloses publicly all medical research results that are significant to patients, health care providers or
`payers-whether favorable or unfavorable to a Lilly product-in an accur