Introduction to Clinical Trials

Transcript

• 00:00Hello, thank you for being here and
• 00:03welcome to the Clinical Trials Office.
• 00:06My name is Trisha Borrello and I'm
• 00:07excited to be discussing clinical
• 00:09trials with you today over the next 40
• 00:12minutes we will be reviewing a high
• 00:14level overview of clinical trials.
• 00:16You will learn more about your specific role
• 00:19and responsibilities through other trainings.
• 00:21Working with your manager and your teams.
• 00:24The learning objectives for this
• 00:26presentation will be defining a
• 00:28clinical trial understanding why
• 00:29clinical trials are conducted,
• 00:31identifying the different types
• 00:33and phases of clinical trials,
• 00:34as well as understanding the
• 00:36life cycle of a clinical trial.
• 00:39You have an important role
• 00:40to play in clinical trials,
• 00:41so let's begin here and better
• 00:44understand what clinical trials are.
• 00:46Defined by the FDA,
• 00:47a clinical trial is a research study
• 00:49in which people volunteer to help find
• 00:52answers to specific health questions.
• 00:54When conducted carefully,
• 00:56they are in fact the fastest and
• 00:58safest way to find new treatments.
• 01:00Volunteers who participate in the
• 01:02study must agree to the rules and
• 01:05terms outlined in a protocol.
• 01:06Similarly, researchers,
• 01:07doctors and other healthcare professionals
• 01:10who manage the clinical trial must
• 01:12follow strict rules set forth by the FDA.
• 01:15These rules make sure that those who
• 01:18agree to participate are treated safely.
• 01:20A clinical trial is carried out through
• 01:22a thorough and thoughtful plan,
• 01:23which is called a protocol.
• 01:25Within the protocol you'll find
• 01:27descriptions of the types of
• 01:28patients may enter into the study.
• 01:30The schedules of tests and procedures,
• 01:33the drugs involved,
• 01:34the dosage or amount of drug,
• 01:36the length of the study,
• 01:38and what the researchers hope
• 01:39to learn from the study.
• 01:44Clinical trials are conducted
• 01:46for many different reasons.
• 01:48First, determine whether a
• 01:49new drug or device is safe and
• 01:51effective for the use in people.
• 01:53Second, to study different ways
• 01:55to use standard treatments or
• 01:57current approved treatments so
• 01:58that they can be more effective,
• 02:00easier, or decrease side effects.
• 02:043rd to learn how to safely use a
• 02:06treatment in a population for which that
• 02:08treatment is not currently being used.
• 02:10And lastly,
• 02:11to answer scientific questions and
• 02:13find better ways to prevent diagnose.
• 02:15And treat diseases,
• 02:16including cancer.
• 02:20So you might be asking yourself
• 02:21at this point, why would patients
• 02:23volunteer to be in a clinical trial?
• 02:25Well, here are a few reasons.
• 02:27Some people participate in clinical
• 02:29trials because their current treatment
• 02:32is no longer working or they're having
• 02:34some type of intolerable side effects.
• 02:372nd participants with an illness or
• 02:39disease may want to help others,
• 02:41but also by participating in clinical trial.
• 02:44You might be receiving the newest
• 02:45treatment and you will also have the
• 02:47additional care and attention from a
• 02:49clinical trial staff that you wouldn't
• 02:51have if you were not in the clinical trial.
• 02:55Lastly participants may be drawn to
• 02:57clinical trial because they want
• 02:59to contribute to the advancement
• 03:02of medical knowledge.
• 03:03All clinical trials have guidelines
• 03:05called eligibility criteria.
• 03:07This eligibility criteria,
• 03:08which you'll become more familiar
• 03:09with over the next several weeks,
• 03:11define the type of patient or participant
• 03:14that we're looking for in a clinical trial.
• 03:16The criteria usually use factors such as age,
• 03:20sex, type and stage of disease,
• 03:22previous treatment history,
• 03:23and other medical conditions.
• 03:25The reason that we have such strict
• 03:28criteria for enrolling patients into
• 03:29a trial is because we want to ensure
• 03:32that we reduce the variation within
• 03:33the study so that the researchers
• 03:35are able to answer the question
• 03:37they had outlined in the Protocol.
• 03:39Therefore,
• 03:40not everyone who applies for a
• 03:42clinical trial will necessarily be
• 03:44accepted following the eligibility
• 03:45criteria is extremely important
• 03:47because it's important to test
• 03:49drugs and medical products and the
• 03:51people that they are meant to help.
• 03:52It's also important to conduct research
• 03:54in a variety of different people.
• 03:56Because different people may have
• 03:59different responses to treatment.
• 04:01The FDA seeks to ensure that
• 04:03the people of different ages,
• 04:04races,
• 04:04ethnicities and genders are
• 04:06included in clinical trials.
• 04:08At the end of this presentation,
• 04:10I'll give you some links that you
• 04:11may look at and educate yourself more
• 04:14about diversity in clinical trials.
• 04:19Before we get into where our
• 04:21clinical trials are conducted,
• 04:22I first want to review what a sponsor is.
• 04:25A sponsor is a person,
• 04:26company, institution, group,
• 04:28organization that overseas or
• 04:30pays for a clinical trial,
• 04:32and at the end of the study they
• 04:35collect and analyze the data.
• 04:37Clinical trials are sponsored by a
• 04:39number of different organizations,
• 04:40such as those seen on your screen
• 04:42from suidical companies.
• 04:43The NIH Veteran affairs,
• 04:46and doctors or health care providers.
• 04:48It's the sponsor's responsibility to
• 04:50determine the location of the trials.
• 04:52Clinical trials may be conducted
• 04:54at universities,
• 04:55medical centers,
• 04:56federally or institutionally
• 04:58funded research sites,
• 05:00clinics and hospitals.
• 05:06The FDA works to protect participants
• 05:08in clinical trials and to ensure that
• 05:11participants have reliable information
• 05:13before joining the clinical study.
• 05:16The informed consent is part of the process
• 05:19that makes sure patients understand that
• 05:21clinical research is in fact, research.
• 05:24That they have the information about known
• 05:27risks associated with the clinical trial.
• 05:30And that participating in a
• 05:31clinical trial is voluntary.
• 05:33And then they have the right
• 05:34to withdraw at anytime without
• 05:36affecting the current medical care.
• 05:39The federal government has regulations and
• 05:42guidelines for clinical research to protect
• 05:45participants from unreasonable risks.
• 05:47Although all efforts are made to
• 05:48control the risks of participants,
• 05:50some may be unavoidable because
• 05:52we're still learning more about the
• 05:54medical treatments in the study.
• 05:57Therefore,
• 05:57the government requires researchers
• 05:59to give prospective patients complete
• 06:01and accurate information about
• 06:03what will happen during the trial.
• 06:05Before joining a particular study,
• 06:08participants must sign that informed
• 06:10consent that describes their rights as
• 06:12a participant as well as the details
• 06:14about the study and really importantly,
• 06:16any potential risks.
• 06:21An important acronym to Know is an Ind,
• 06:24an investigational new drug.
• 06:26We're going to spend the next few
• 06:29slides reviewing what an IMD is.
• 06:30Before we get started,
• 06:32the definition of an Ind is a submission
• 06:34to the Food and Drug Administration.
• 06:36The FDA requesting new permission
• 06:38to initiate a clinical trial of
• 06:41a new drug product or an approved
• 06:43drug used for a new indication
• 06:46or a new patient population.
• 06:48The federal food, Drug,
• 06:49and Cosmetic Act requires that
• 06:51drugs have an approved marketing
• 06:53application before they can be
• 06:55shipped in Interstate commerce.
• 06:57The IMD allows a company to initiate
• 06:59and conduct clinical trials for
• 07:01their new drug products and the and
• 07:03application provides the FDA with
• 07:05the needed data to decide whether
• 07:07or not the new drug proposed is a
• 07:09reasonable risk to human subjects
• 07:11participating in the study.
• 07:16And I and is required anytime we want
• 07:18to conduct a clinical trial of an
• 07:21unapproved drug and I and would be
• 07:23required to conduct a clinical trial.
• 07:24If there's a new chemical entity not
• 07:27approved for the indication under
• 07:28the investigation in a new dose form,
• 07:31we are administering a drug at a new
• 07:33dose level or this new drug is being
• 07:36used in combination with other drugs and
• 07:38the combination is not currently approved.
• 07:41All clinical studies where a new drug
• 07:43is administered to human subjects,
• 07:45regardless of whether their drug
• 07:46will be commercially developed,
• 07:48require an ID.
• 07:50And I and D would not be required if the
• 07:53drug is not intended for human subjects,
• 07:55but is intended in in vivo testing
• 07:58or research lab animals,
• 08:00also known as non clinical studies
• 08:02or an improved drug,
• 08:03and the study is within the current
• 08:06approved indication for that use.
• 08:11There are few different types of imds
• 08:13that I wanted to review with you today.
• 08:15The first is an investigator island
• 08:17which is submitted by a physician
• 08:19who initiates and conducts the
• 08:21investigation and under whose immediate
• 08:23direction the investigational drug
• 08:25is administered or dispensed.
• 08:27Physician might submit a research.
• 08:29Indd to propose studying an unapproved
• 08:31drug or an approved product for a new
• 08:34indication in a new patient population.
• 08:372nd is the emergency use I and the
• 08:40emergency use I and D allows the FDA
• 08:42to authorize use of an experimental
• 08:44drug in emergency type situation.
• 08:47This bypasses all the need of the
• 08:50physician or investigator Ind noted above
• 08:54because timelines are vitally important.
• 08:57Treatment Ind is submitted for
• 08:58experimental drugs showing promise in
• 09:00the clinical setting for serious or
• 09:03immediately life threatening conditions,
• 09:04while a final clinical work is conducted
• 09:07and the FDA reviews take place.
• 09:13Indeed, can be classified into two
• 09:15separate groups, commercial and research.
• 09:17Commercial imds permit the sponsor
• 09:19to collect data on clinical safety
• 09:22and effectiveness needed for the
• 09:24marketing application in the form
• 09:26of a new drug application, an NDA.
• 09:30The NDA is an application vehicle
• 09:32through which the sponsors formally
• 09:35propose that the FDA approved a new
• 09:38pharmalogical for sale or and marketing.
• 09:41Research non commercial permits a
• 09:42sponsor to use drug and research
• 09:44to obtain advanced scientific
• 09:46knowledge of a new drug with the
• 09:48no plans to take this to market.
• 09:56Remember from earlier sponsor,
• 09:57a person, company, institution,
• 09:59group or organization that overseas
• 10:01pays for a clinical trial and
• 10:03collects and analyzes the data.
• 10:05Let's talk about some of these
• 10:07sponsors and who would hold
• 10:09the island in these situations.
• 10:11The type of trials typically
• 10:13defined by the primary sponsor.
• 10:15So who holds I and D?
• 10:17Well, we first have an investigator
• 10:19initiated trials here in
• 10:20the Clinical Trials Office.
• 10:22This might be a Yale investigator who
• 10:24would hold the Ind with the institution.
• 10:27We also conduct external aids where
• 10:29we have a non Yale investigator who
• 10:32has an IIT opening up at Yale as a
• 10:36special site or a specific site.
• 10:39An example would be city of hope.
• 10:432nd, we have National Cancer
• 10:46Trial network, also known as the
• 10:48NPTN or cooperative group trials.
• 10:53At the NTN group level,
• 10:55the Indy is held by a number of
• 10:59different entities who may be performing
• 11:01or the sponsor of a trial alliance.
• 11:03ECOG Akron Energy swag and Cog
• 11:06are all acronyms and sponsors,
• 11:09so you'll become more familiar
• 11:11with over the next several months.
• 11:13The Experimental Therapeutics Clinical
• 11:16Trials Network or ETN then SCI holds
• 11:20the and the ETN was created to evaluate
• 11:23early therapeutics using a coordinated,
• 11:25collaborative and inclusive team based
• 11:27approach to early phase experimental
• 11:30therapeutic clinical trials.
• 11:31You might have heard a little
• 11:32bit more about these in.
• 11:33You're welcome to the clinical
• 11:35trials presentation.
• 11:36Lastly, we have the industry
• 11:38trial in which a pharmaceutical
• 11:40or biotech company holds the Ind.
• 11:45Let's look at the different
• 11:47types of clinical research first.
• 11:49We have a treatment.
• 11:50Research this type of research is generally
• 11:52involves some type of intervention,
• 11:53whether it be medication, psychotherapy,
• 11:56a device, or new approach to
• 11:58surgery or radiation therapy.
• 12:00Next, we have a prevention study
• 12:02which looks at better ways to prevent
• 12:05disorders from developing or returning.
• 12:07Different kinds of prevention
• 12:09studies might be study medications,
• 12:11vitamins, lifestyle changes.
• 12:12Next, we have diagnostic research
• 12:15which refers to the practice of
• 12:17looking at better ways to identify
• 12:20particular disorder or condition.
• 12:22Screening research,
• 12:23which is what aims to find the best
• 12:26way to detect certain disorders
• 12:28or health conditions.
• 12:29Then we have quality of life research
• 12:31which explores different ways to
• 12:33improve comfort and quality of life and
• 12:35individuals with chronic illnesses.
• 12:37Next genetic studies which aim to
• 12:39improve the prediction of disorders
• 12:41by identifying and understanding how
• 12:43genes and illnesses may be related.
• 12:46Lastly,
• 12:46epidemiological studies which
• 12:48seek to identify the patterns,
• 12:51causes,
• 12:51and controls the disorders in a group.
• 12:55Breaking down the types of cancer
• 12:56trials a little bit more,
• 12:58let's talk about non therapeutic or
• 13:01concept and preventative trials of note.
• 13:04The Clinical Trials Office does
• 13:06not typically participate in
• 13:07these type of clinical trials,
• 13:09but if you are interested in
• 13:11additional information or reading
• 13:12material after the presentation,
• 13:14you can click on the hyperlinks
• 13:15that are provided in this page
• 13:17for non therapeutic trials.
• 13:18These are preclinical and prevention trials.
• 13:21Preclinical studies are the research used
• 13:23to find out if the drug will proceed.
• 13:26To a treatment,
• 13:27prevention studies are looking at
• 13:29testing of new interventions that
• 13:31may lower the risk of developing
• 13:33certain types of cancer.
• 13:35Within prevention studies we have
• 13:38chemopreventive trials and preventative
• 13:40studies in the CHEMOPREVENTIVE trials.
• 13:42These trials use the specific agents
• 13:44to express or reverse carcinogens
• 13:46and therefore preventing the
• 13:48cancer development and preventative
• 13:51trials we look at trials,
• 13:52including healthy individuals at
• 13:54a high risk for developing cancer.
• 13:57Preventative studies help answer
• 13:59specific questions about and evaluate
• 14:01the effectiveness of ways to reduce
• 14:03the risk of developing cancer.
• 14:07Now what you're going to see most
• 14:09within the Clinical Trials Office,
• 14:11and you'll become more familiar
• 14:12with our therapeutic trials,
• 14:14compassionate use and expanded access
• 14:16and ancillary therapeutic trials that
• 14:18are phase one through 4 studies,
• 14:20which we'll talk about in a little bit.
• 14:22However, in these studies we enroll,
• 14:24diagnose subjects and provide
• 14:26a specific treatment to study
• 14:28its impact on their cancer.
• 14:30For compassionate use and expanded
• 14:33access trials, the use of a.
• 14:35Investigational product outside of
• 14:37the clinical trial to treat a patient
• 14:40or patients who has no comparable
• 14:42or satisfactory alternative option.
• 14:45Lastly, ancillary research which
• 14:47addresses a scientific question
• 14:49related to a parent study that
• 14:52requires access to records,
• 14:54data and the parent study and may involve
• 14:57additional data specimens or records
• 14:59of the subject of the parent study.
• 15:02Before we dive into clinical trials,
• 15:04I'm going to have us watch a quick video.
• 15:11Clinical trials are research
• 15:13studies that involve people,
• 15:15most clinical trials to test new
• 15:17cancer treatments are done in a
• 15:19series of steps called phases.
• 15:21If a new treatment is successful in
• 15:23one phase, it moves to the next phase.
• 15:26Let's take a look at the three
• 15:28main phases of clinical trials.
• 15:30Phase One trials are small,
• 15:32enrolling less than 30 patients.
• 15:35Phase One trials are designed to find
• 15:38a safe dose of the new treatment.
• 15:41Determine how the treatment should be given.
• 15:44And learn how it affects the body.
• 15:51If a safe dose is found,
• 15:52the new treatment goes to phase two.
• 15:54Testing more patients are enrolled,
• 15:57usually 100 or less.
• 15:58Phase two trials study how
• 16:00the treatment affects the body
• 16:02and how the treatment works
• 16:04for a certain type of cancer.
• 16:06If a new treatment is found to
• 16:08be safe and to have some benefit.
• 16:12It goes to phase three.
• 16:14This is when many participants
• 16:16are needed, usually more than
• 16:18100 and sometimes thousands.
• 16:21These three trials compare the
• 16:22new treatment with the current
• 16:24treatment to see which one is better.
• 16:28One thing is certain,
• 16:29with any phase trial,
• 16:30by taking part you will help
• 16:32future patients by helping.
• 16:33Today scientists learn more about cancer.
• 16:38For more information about clinical trials,
• 16:40including their possible
• 16:41risks and benefits for you,
• 16:43go to cancer.gov/clinical trials.
• 16:55I hope you found that presentation helpful.
• 16:58Let's recap what we just learned.
• 17:01For phase one trials,
• 17:02this is the first Test in humans.
• 17:04Typically we're not testing more
• 17:06than 20 to 100 healthy subjects.
• 17:08Some exceptions include
• 17:10oncology and HIV trials.
• 17:13Within a phase one study,
• 17:14we're really determining the
• 17:16safety of the treatment.
• 17:18Discovering the correct dose and
• 17:20the best delivery method as well as
• 17:23identifying some of the potential
• 17:25side effects of the new drug.
• 17:27Within a phase one study,
• 17:28we're hoping to determine the
• 17:30dosage and the amount of treatment,
• 17:32identify side effects and typically.
• 17:36These type of trials last
• 17:38about a year and a half.
• 17:40A phase two study is going to be
• 17:42larger than our phase one can be
• 17:44up to several 100 participants,
• 17:45then a phase two study.
• 17:46We're looking at patients with the
• 17:49disease or condition targeted by the therapy.
• 17:51We are now looking at the
• 17:53effectiveness of the treatment.
• 17:55And we are testing its efficacy and
• 17:58further evaluation of its safety.
• 18:01These studies in the last
• 18:02several months up to two years.
• 18:06As drugs continued,
• 18:07the show being effective and overall safe,
• 18:10we'll move on to phase three trial.
• 18:12These are much larger studies.
• 18:15Containing 300 to 3000 patients.
• 18:18They confirm effectiveness.
• 18:19Monitor side effects or adverse
• 18:22reactions compared to other treatments
• 18:25that may already be available.
• 18:28Collect other information for safe use
• 18:30and typically take one to four years.
• 18:34Lastly, we have our phase four trials.
• 18:37Which includes several thousand patients
• 18:38who have the disease or condition.
• 18:41These are typically post marketing
• 18:43studies and provide additional information
• 18:45about risk, benefit, optimal use,
• 18:47and tests for new indications.
• 18:50We additionally see what are
• 18:52called combined phase trials.
• 18:54A phase one, two or a Phase 2/3.
• 18:58Protocols can be written to make
• 19:00two separate sets of adjectives.
• 19:02Often eligibility will be different
• 19:04for the phase two or phase three study
• 19:07than the phase one or phase two study.
• 19:09This information will all be
• 19:12found in the protocol.
• 19:14Now that we've learned more
• 19:15about the phases of trials,
• 19:16let's take a quick step back and
• 19:19define standard of care versus
• 19:22clinical trial participation.
• 19:23Standard of care.
• 19:24Often shortened to SoC now that we
• 19:27know about the phases of trial,
• 19:29let's talk about standard.
• 19:33Let's talk about standard of
• 19:35care for clinical trials.
• 19:37First, let's review standard of care.
• 19:39Also shortened to SoC.
• 19:43Standard of care is an FDA approved
• 19:45treatment for the patient's cancer type.
• 19:48The ramifications for these treatments
• 19:51affect the individual patient.
• 19:53And it's the normal medical care and
• 19:56patient contact that we're used to.
• 19:59This standard of care is the best
• 20:02treatment that we have currently, and.
• 20:04It allows the physicians to change
• 20:08the schedule or the cycle length.
• 20:11Within a clinical trial,
• 20:13the study, subject,
• 20:14or participant must sign the most
• 20:17recently IRB approved informed consent.
• 20:20And the ramifications for research and
• 20:24clinical trials affect future patients.
• 20:26Within the clinical trial,
• 20:29we are administering an
• 20:31investigational product.
• 20:32Participants are closely
• 20:33followed by the medical team and
• 20:36often have more time on site.
• 20:38There is additional data collection
• 20:41requirements that are outlined
• 20:43within the protocol and specific
• 20:45documentation that must be
• 20:46available to support the data entry.
• 20:49Treatment schedules are clearly
• 20:51outlined within the protocol
• 20:52and are protocol driven,
• 20:54and the protocol is to be followed
• 20:56unless subject safety is at risk.
• 21:05Earlier in this presentation,
• 21:06we talked briefly about making sure
• 21:09that patients know the risks and
• 21:11benefits of participating in the trial.
• 21:13Let's start with benefits.
• 21:14Well designed and executed, clinical
• 21:16trials provide the best approach for.
• 21:19Helping others by contributing to knowledge
• 21:22about new treatments or procedures.
• 21:24Gaining access to new research treatments
• 21:27before they are widely available.
• 21:29And receive regular and careful medical
• 21:32care and attention from the research team,
• 21:34including the doctors and other
• 21:37health care professionals.
• 21:38Wrists may be unpleasant, serious,
• 21:41or even life threatening effects
• 21:44of experimental treatment.
• 21:45The study may require more time
• 21:47and attention than the standard
• 21:48of treatment would, including.
• 21:50Including visits to the study site,
• 21:54more blood tests,
• 21:55more procedures,
• 21:56overnight hospital stays or complex
• 21:59dosing schedules.
• 22:06I've got another video for you.
• 22:07It's about 2 minutes long and
• 22:09it's going to review patient
• 22:10safety and clinical trials.
• 22:16Patient safety in clinical trials.
• 22:19The most important member of any
• 22:21clinical trial team is you, the patient.
• 22:23So important that efforts to protect
• 22:26your safety began even before the trial
• 22:28itself does a clinical trial in the
• 22:31US may only enroll patients after its
• 22:33protocol is approved by a group called
• 22:36an Institutional Review Board or IRB.
• 22:38IRB members include scientists as well
• 22:41as nurses, advocates, and others.
• 22:43Their job is to monitor the clinical trials.
• 22:46And protect participants safety.
• 22:47The protocol describes the study's
• 22:50goals and methods and outlines how the
• 22:52participants safety will be ensured.
• 22:54IRB members review the protocol to make
• 22:56sure that the risk of harms is as low as
• 22:59possible and that any potential harms
• 23:01are a reasonable part of the research study.
• 23:04Another important safety step is the informed
• 23:07consent process before you can join a trial.
• 23:10The research team will fully discuss the
• 23:12trial with you if you decide to join,
• 23:14you will sign an informed consent form.
• 23:16To confirm that you
• 23:17understand what's involved,
• 23:18you are encouraged to ask questions at any
• 23:21point before or after joining the study.
• 23:23And of course,
• 23:24you may always choose to leave the study.
• 23:26It's completely up to you.
• 23:28Once a study begins,
• 23:29its scientific progress and the safety of
• 23:32its participants are regularly monitored.
• 23:34The study may be changed or even
• 23:36stopped to ensure the patient safety
• 23:38clinical trial participants are
• 23:40a vital part of Cancer Research.
• 23:42Better cancer care tomorrow depends on
• 23:44what we learn from clinical trials.
• 23:46Today,
• 23:46for more on how your safety is
• 23:49protected on clinical trials,
• 23:51visit the National Cancer Institute's website
• 23:55at cancer.gov/patientsafety and thank you.
• 24:00US departments of Health and Human
• 24:02services National Institutes of
• 24:04Health National Cancer Institute
• 24:05cancer Gov One 800 for cancer.
• 24:08I hope you found that presentation helpful.
• 24:12When talking about protection of
• 24:14clinical trials participants.
• 24:15Here at the university we have several
• 24:18different committees that ensure that
• 24:20our patients are being protected.
• 24:22Research involving human
• 24:23participants must be conducted in
• 24:26coordinates with applicable laws,
• 24:28regulations, guidelines,
• 24:29and ethical principles such as those
• 24:33outlined in the Belmont report.
• 24:35Yale University Human Research
• 24:38protection program will call HRPP.
• 24:41Is under the oversight?
• 24:42Of the deputy of Provost of Research
• 24:45here at Yale and within the
• 24:47Office of Research Administration,
• 24:50they are responsible for the protection
• 24:52of the rights and welfare of human
• 24:54subjects in research projects
• 24:56conducted at Yale by Yale faculty,
• 24:58staff, and students,
• 25:00and by the investigators with several
• 25:03affiliates and by investigators
• 25:05from several affiliate institutions.
• 25:07The Yale harp.
• 25:09Includes the IRB who is responsible
• 25:12for ensuring the rights and welfare
• 25:15of human research participants.
• 25:17Promoting excellence in the conduct
• 25:19of research and advancing scientific
• 25:22knowledge and quality research.
• 25:24Our Yale HRP also assists with
• 25:27radioactive Drug research Committee,
• 25:29radioactive Investigational Drug
• 25:31Committee and our embryonic stem
• 25:34cell research Oversight committee.
• 25:36To learn more after the presentation,
• 25:39visit our human research protection program.
• 25:42It's your Yale link provided on this page.
• 25:45I don't think that we can talk about
• 25:47clinical trials without talking
• 25:49about ethics and regulatory,
• 25:50so let's start with some history.
• 25:53First the Hippocratic Oath.
• 25:56This oath requires that physician
• 25:58swear that he or she will uphold a
• 26:01number of professional ethical standards.
• 26:03First,
• 26:04do no harm is the underlying promise made?
• 26:08Rarely used in modern medical
• 26:09schools but still offering.
• 26:11Referred to Nuremberg code.
• 26:15Introduced in the summer of 1947 in
• 26:18response to the human experiments
• 26:20that were uncovered during the
• 26:23Nuremberg Trials on the concentration
• 26:25camp prisoners by the Nazi doctors.
• 26:27Next, the declaration of Helsinki,
• 26:30a set of ethical guidelines for
• 26:32physicians and others who participate
• 26:34in medical research.
• 26:35It is considered the cornerstone
• 26:38document pertaining to medical
• 26:40research ethics.
• 26:41Followed by the US National Research Act,
• 26:44which was established in 1974.
• 26:47This act was contacted by the 93rd
• 26:50United States Congress and signed into
• 26:53law by President Nixon on July 12th,
• 26:551974.
• 26:56After a series of congressional
• 26:58hearings on human subject research.
• 27:02The Tuskegee Syphilis study was
• 27:04conducted from 1932 to 1972.
• 27:06Hundreds of African Americans who
• 27:08were not informed of their diagnosis,
• 27:12which had a cure that was available
• 27:14in the 1950s.
• 27:16But not offered to study participants
• 27:18as the treatment was denied until 1972.
• 27:21They were chosen to participate based
• 27:24off of race and gender and economic status.
• 27:27The Belmont report was written
• 27:29in response to these events.
• 27:31The National Research Act established
• 27:33that the National Committee for the
• 27:35Protection of Human Subjects require
• 27:37public health service to regulate for
• 27:39the protection of human subjects.
• 27:41Title 45 of the code.
• 27:42Federal regulations,
• 27:43later known as the common role,
• 27:45requires appointed and utilization
• 27:47of institutional review boards.
• 27:49The Belmont report was written by
• 27:51the National Commission for the
• 27:53Protection of Human Subjects of
• 27:55Biomedical and Behavioral Research.
• 27:56It is a statement of basic ethical
• 27:59principles and guidelines that provide.
• 28:01Analytical timeframe to guide the
• 28:04resolution of ethical problems that
• 28:06arise from research with human subjects.
• 28:08The basic ethical principles outlined in
• 28:11the report include respect for persons
• 28:14entailing treating individuals as autonomous
• 28:17persons capable of choosing for themselves.
• 28:21Beneficence requires an
• 28:23assessment of potential risks,
• 28:25probable harm to the anticipated benefits,
• 28:28promotion of health well being,
• 28:30or welfare and justice.
• 28:32This principle advocates fair treatment
• 28:34for all and a fair distribution of
• 28:37risk and benefit of the research.
• 28:39Finally, we get to good clinical practice.
• 28:41Good clinical practice has
• 28:44overarching themes of responsibility,
• 28:47attention, and detail.
• 28:48Documentation quality such as data.
• 28:51And scientific quality,
• 28:53ethical quality, process quality,
• 28:55risk and risk management as well as
• 28:59validation verification and expection.
• 29:01Good clinical practice is an international,
• 29:04ethical and scientific quality standard
• 29:06for designing, conducting, recording,
• 29:08and reporting trials that involve
• 29:11the participation of human subjects.
• 29:13This will not be the last time that
• 29:15you hear of a number of these.
• 29:16Continuing with the rights of
• 29:18clinical trial participants.
• 29:20We have informed consent.
• 29:23Which,
• 29:23as we discussed earlier,
• 29:25is something that a patient can
• 29:27withdraw from at anytime they are
• 29:29free from coercion when signing
• 29:31these informed consents,
• 29:32and we provide extra protections
• 29:34for vulnerable populations,
• 29:36such as prisoners,
• 29:37pregnant women and children.
• 29:39We've gone over a lot today,
• 29:41and I'd like to wrap up with what
• 29:43happens when a clinical trial is completed.
• 29:46First, data is analyzed after
• 29:49participant activities have ended.
• 29:51The data are clean and analyzed
• 29:53into data sets.
• 29:54We are required by law to submit
• 29:57clinical trial results no later than
• 29:59one year after the completed data.
• 30:01Posters and presentations at medical
• 30:04and research conferences may take place.
• 30:07Publications may occur at the time during
• 30:09the course of the clinical trial life cycle,
• 30:12although it most often
• 30:13happens at study completion.
• 30:14Several publications may
• 30:16result from one trial.
• 30:18And finally,
• 30:18we have our regulatory application.
• 30:20Clinical trials are required by
• 30:22regulatory authorities and countries
• 30:24around the world before a new
• 30:26medical product can be brought to
• 30:28market or before a new indication,
• 30:30formulation or target population
• 30:31can be approved for an intervention
• 30:34already on the market.
• 30:36Do you remember what this is called?
• 30:38A new drug application.
• 30:40Why are clinical trials so important today?
• 30:43People are living longer lives from
• 30:46successful cancer treatments that are
• 30:48the results of past clinical trials.
• 30:50Through clinical trials,
• 30:52doctors determine whether new treatments
• 30:54are safe and effective and work
• 30:56better than the current treatments.
• 30:58Clinical trials help us find new
• 31:00ways to prevent and detect cancer.
• 31:02And they help us improve the quality of
• 31:04life for people during and after treatment.
• 31:09Thank you so much for listening
• 31:11to this presentation.
• 31:11If you have any follow up questions,
• 31:13please be sure to reach out to your manager.
• 31:15I want to thank everyone who took part
• 31:17in creating this PowerPoint presentation.
• 31:20The training, education team,
• 31:21managers and staff that reviewed
• 31:23and allowed this to be possible.
• 31:27Before a part, I want to provide you
• 31:29with some helpful information that you
• 31:31can browse on your own to continue
• 31:33your knowledge about clinical trials.
• 31:35Again, thank you so much for your
• 31:37time and enjoy the rest of your day.