The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone six revisions (the most recent at the General Assembly in October 2008) and two clarifications, growing considerably in length from 11 to 35 paragraphs (35 paragraphs in 2008 version). The Declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents.
IPPOSI is a unique partnership of Patient Organisations, Science and Industry on the island of Ireland. As a patient-led partnership, the platform provides a structured way of facilitating interaction between the three key membership groups (patients' organisations, scientists and industry (and where possible with State Agencies) on policy, legislation and regulation around the development of new medicines, products, devices and diagnostics for unmet medical needs in Ireland.
“So you’ve been asked to take part in a clinical trial?” Launched this month.The IPPOSI seeks to ensure patients in Ireland have prompt access to new and developing innovative therapies. IPPOSI is not a lobbying organisation but via expertise, dialogue, consensus and networking we work to smooth the path in Ireland for new medicines and therapies to move from basic science in laboratories to the patients who need them.IPPOSI is part funded by the Health Research Board, Irelandfor more information visit http://www.ipposi.ie
Clinical trials: exploring your options - Deirdre McDonnell
Supporting People with Breast Cancer 2012 Annual Patient Conference Clinical Trials – Exploring your Options Deirdre McDonnell Clinical Research Nurse St. Vincents University Hospital
Options•You will usually be invited to take part in a clinical trial becauseyou are a patient who needs treatment. If your hospital has aclinical trial open that might be suitable for you, You may beoffered this trial and will then have to consider your options.•It is not an easy decision. You will have to weigh up all the prosand cons of either option and decide what‟s important to you andwhat type of treatment your happy with.
What are my options? Best Clinical trial licenced participation treatment No conventional treatment
Who conducts trials•Every clinical trial is led by a principle investigator who is oftena medical doctor. The research team may include doctors,nurses, social workers and other health care professionals.•Clinical studies can be sponsored, or funded by pharmaceuticalcompanies, academic medical centres and other organizations inaddition to government agencies.
VoluntaryClinical trial participation is entirely voluntary and you cannottake part in a clinical trial unless you freely give your permission.The rights, safety, and well-being of trial participants are themost important considerations and prevail over interests ofscience and society.
Clinical trials overview Trials terminology More Phases information Demystify Protections Clinical Benefits Trials Informed Drawbacks consent Costs
What is a Clinical Trial?•Cancer research studies are carried out to try and find new andbetter treatments for cancer. Trials which are carried out onpatients are known as clinical trials.•A clinical trial involves research using human volunteers (alsocalled participants) that is intended to add to medicalknowledge.
Why do Clinical Trials?•The aim is to answer specific questions about new medicaltreatments.•Clinical trials are used to determine whether new drugs aresafe and effective.•Clinical trials are conducted in phases and each phase has adifferent purpose.
Why are clinical trials important?•By taking part in clinical trials, cancer patients can help test ifnew approaches to cancer prevention, diagnosis and treatmentare safe and effective. This information will help society andfuture generations.•Due to progress made through clinical trials, many peopletreated for cancer are now living longer and more cancers arebeing cured.•Cancer has touched every family in Ireland and in most casesmore than once. It is vital that we all work together to improvethe future for Irish people with cancer.
Types of Research•Epidemiological research looks for various risk factors forvarious cancers so that the disease may be prevented.•Basic lab research tries to unravel the mystery of the cellsand why some cells behave abnormally and becomecancerous.•Clinical research identifies the most effective therapy orcombination of therapies to treat cancer and other diseases.•Translational Research combines Lab and Clinical Research
1st Clinical Trial?•Perhaps the first ever clinical trial was James Lind‟sdemonstration in 1753 that citrus fruits cured scurvy. Hecompared the effects of various different acidic substancesranging from vinegar to cider, on groups of sailors, and foundthat the group who were given oranges and lemons had largelyrecovered from scurvy after 6 days.
Pre clinical testing•Before scientists can conduct trials in human beings, they mustconduct extensive laboratory research.•Research usually involves years of experiments in animal andhuman cells.
Preclinical testing•If preclinical testing of a drug of is successful, the sponsor thenprovides the data to the Regulatory Body requesting approval tobeing testing in humans.•If approved by the Regulatory body testing in humans begins.This is done through a formally written and approved studyprotocol.
Phase 1•First step in testing in humans.•Establish how a new drug should be given (tablet or injection),how often, and what dose is safe.•Researchers look for safety and potentially harmful side effects.•Usually include only a small number of participants.•This phase of testing usually takes several months.
Phase 2•Once a drug has shown to be safe, then it must be tested forefficacy.•This phase may last from several months to two years.•Usually involves several hundred patients•Most of these trials are randomized trials•Only about 1/3 of studies successfully complete both phase Iand phase 2 due to poor patient activity or toxic effects.
Phase 3•Studies move into phase 3 only after a treatment has shownpromise in phase I and II trials.•Conducted in many centres and include large groups of patients(300-3000)•Compare the results of patients on the experimental Arm tothose patients having standard treatment.•A participant will usually be assigned to the standard group orthe new group at random.•Many phase 3 trials are randomized and blinded.
Drug development•For every 1,000 compounds that are identified by a company, onlyabout 30 show promising results.• And for every 30 compounds that show promise, three get past the firstround of clinical trials and finally, only one hit the market.•Can take 12 – 15 years from an idea to licenced treatment.•It is estimated, according to various sources, that cost of developing asingle new drug including commercialization varies from US $ 800 millionto US $ 1.7 billion
Randomisation•You are assigned to a treatment group by chance, similar to“flipping a coin”.•Randomization helps avoid bias.•The assigned groups are often referred to as “arms”.Example: Patient #1 is assigned to Arm A of the trial, whichinvolves the new treatment.Patient #2 is assigned to Arm B, which is the standardtreatment.
Blinded studiesBlinding means that whoever is assessing the effects oftreatment will not know if they are studying patients on thetreatment or patients on placebo. This helps to prevent bias.Double blinded studies are where neither the patient or thedoctor know whether the patient is receiving the actual studydrug or standard drug.When no standard is available, some studies compare new drugswith placebo drugs.Patients are “unblinded” only if it becomes medically necessaryprior to the end of the study.
What is a placebo?•A placebo is a treatment that does not contain any activesubstance.• It allows investigators to test for the „placebo effect‟. This is apsychological response where people feel better even thoughthey do not take a medicine with an active ingredient.• By comparing people‟s responses to the placebo and to thetreatment being tested, the benefit of the treatment can bedescribed.
What is a protocol?•A study plan on which all clinical trials are based.•Carefully designed to protect the health of all participants.•Describes what types of people may participate in the trial(inclusion and exclusion criteria)•Gives detailed schedule of tests, procedures, medications,dosages, and length of the study.
Considering enrolling in a study?•Your Doctor or Research nurse is there to discuss all aspects ofthe study with you. It is a good idea to have a family member orfriend with you to help ask any questions or just for support.•You will be given a Patient Information Leaflet and anInformed Consent Form to read and discuss.•You should only agree to take part in a trial if you are entirelyhappy with what you are being asked to do.
Informed Consent Form•Informed consent is the process of learning the key facts about aclinical trial before deciding whether or not to participate.• If you sign this form, you confirm that you believe you havebeen given all the important facts about a trial, you understandthem and that you have decided to take part in the trial of yourown free will.•An informed consent is not a contract and you may withdrawfrom the study at any time.
Informed Consent Form•You will be asked to read the information carefully andencouraged to ask as many questions as you wish.•It includes details about: the aim of the study, backgroundinformation about the treatment, how the treatment will begiven and for how long, the benefits and drawbacks, possibleside effects and confidentiality.
Informed Consent Form•If you wish to take part in the study you then sign the consentform.• It may be necessary for a witness to sign the consent form withyou.• You can withdraw your consent at any time if you wish to do soor your doctor may take you off the study if he/she feels it‟s inyour best interest.•If you do not wish to take part you will receive the besttreatment currently available for your condition.
Quality of life•Over the last few years, researchers have developed detailedtests and questionnaires that allow them to measure people‟squality of life.• These allow them to look not only at the effects of a newtreatment on your cancer but also at its much wider effects onyour life as a whole.
Eligibility Criteria•All trials have guidelines about who can take part. These arecalled „eligibility criteria‟, consisting of inclusion criteria (i.e.who is suitable to participate) and exclusion criteria.• Not everyone who suffers from a particular disease can takepart in a trial.•The researchers may only be including a subset of people with aparticular disease.•There may be safety concerns which may exclude you from astudy for example high blood pressure.
Inclusion Criteria• Inclusion criteria help investigators decide who can join a trial.• For example, some trials only include people of a certain age, or at a particular stage in their illness.• You may have to have a medical examination, scans or special tests before enrolling to assess whether you are suitable to take part.
Potential Benefits•You may be one of the first to benefit from the latest cancertreatments before it becomes widely available•Your health care and response to treatment will be closelymonitored during and after the trial.•You have an opportunity to contribute to science and provideinformation which may be of benefit to you and others with thesame health problem.•Research has found that people receiving treatment withinclinical trials tend to do better than similar patients treatedoutside trials.
Potential Drawbacks•You may not always receive the new treatment, or the newtreatment may not prove to be any better than treatmentscurrently available.•The new treatment may be effective but may not work for you.•New treatments may cause side effects not previously known todoctors.•You may have to visit the clinic or hospital more often becauseyou are being monitored more closely•You may have to undergo more tests (for example blood tests)then you would usually have in routine care
Costs?•You do not have to pay for treatments received as part of astudy.•You may have to pay for treatments which are consideredstandard of care.•Some clinical trial sponsors will reimburse travel expenses forextra visits.•Clinical trials are usually funded by pharmaceutical companies.•Your Study Doctor/Hospital will receive payments for conductingclinical trials.
What regulations are in place?The Nuremberg Code is a set of research ethics principles forhuman experimentation set as a result of the SubsequentNuremberg Trials at the end of the Second World War.The “Declaration of Helsinki” was developed by the WorldMedical Association 1964. This sets the ethical standards forresearch involving human beings, human material or identifiabledata.
What regulations are in place?•Since 2004, clinical trials in Ireland involving medicinal productsfor human use have been covered by the European Communities(Clinical Trials on Medicinal Products for Human Use) Regulations.•ICH -GCP International conference for the harmonization ofGood Clinical Practice.•All trials are also closely regulated by the Irish Medicines Board(IMB).
How are you protected?•A clinical trial has to be approved by the Irish Medicines Board.•This government department decides if a clinical trial can takeplace in Ireland.•It ensures that the trial will be carried out in line with currentIrish, EU and International standards for clinical research.
How are you protected?•A Clinical trial has to be approved by a national EthicsCommittee•An Ethics Committee must have at least 5 members and iscomposed of health care professionals and investigators as wellas members of the public.•You must be thoroughly informed about a study‟s treatments andtests before deciding whether or not to participate in the studyand sign an informed consent form.
Questions to ask……•What is the purpose of the trial?• What is the trial called?• What treatment will I be receiving?• What is the difference between the trial treatment and standardtreatment?• What are the side effects of the trial treatment?• What are the benefits and risks of taking part in the trial?• How many patients are taking part in this trial?• Are there any extra hospital visits required?• Will the trial cost me money?• What treatment will I have if I do not want to take part in thetrial?• What will happen if I want to discontinue the trial treatment?• When will the trial results be available?
Exploring your optionswww.icorg.ie• All Ireland Cooperative Oncology Research Group.You can log on and find out what clinical trials are currently openin Ireland for different types of cancer and what hospitals areparticipating in the studies.www.cancer.ie• The Irish Cancer website has information on Current researchin Ireland.
ICORG Breast cancer studies•SUPREMO ICORG 04-11•CADY ICORG 08-01• NSABP B-39 ICORG 08-06•TRIO 018 ICORG 09-01• Proteomic Study of Breast Cancer ICORG 09-07•Lap/Epi Phase II ICORG 09-13•MYOCET ICORG 10-03•TCHL ICORG 10-05•TROG/BIG DCIS ICORG 10-06•Denosumab D-CARE Amgen ICORG 10-08•Circulating miRNAs ICORG 10-11•Sorafenib MBC ICORG 11-06•GSK EGF114299 ICORG 11-08•TH v THL ICORG 11-10•NSABP B-47 ICORG 11-24•SWOG S1007 ICORG 12-01•
Exploring your optionswww.clinicaltrialsregister.euSince March 2011 the European Medicines Agency has made adatabase of drug clinical trials publically accessiblewww.clinicaltrials.govIn the US, the authorities have created a website where trialsconducted around the world can be found.
IPPOSI is a unique partnership of Patient Organisations, Science and Industry. Thispatient led group focuses on policy, legislation and regulation around thedevelopment of new medicines.
I wish to pay tribute to all the brave women and men who haveparticipated in trials of the past to provide us with the treatments oftoday….and to the brave women and men participating in trials today providingus with the treatments of tomorrow. Thank you Deirdre McDonnell