CLINICAL TRIALS by alicejenny

VIEWS: 6 PAGES: 21

									CLINICAL TRIALS

Prof. Dr. Ahmet Demirkazık
 NEW DRUG DEVELOPMENT
• Many drugs had been developed in
  universities until recently. But today, drug
  companies develop most of the drugs.
• In 1999, CIBA, GEIGY and SANDOZNOVARTIS
• Last year, RHONE POULENC and HOECHST 
  AVENTIS
• This year, PFIZER bought PHARMACIA
• Next year?
   Drug Development Is a Very
        Expensive Work

• Expenses for drugs in the World were 363
  billion dollars in the year of 2000 (Turkey‟s
  budget was 2.7 billion dollars)
• In the same year 40-50 billion dollars were
  spent for drug development research
           Clinical Trial or
         Standard Treatment

• Good treatment and good care modalities
  whether the patients take part in clinical
  trials or receive standard treatments.
• The patient may decide not to take part in a
  trial, and he or she can still receive good
  medical care.
    WHAT IS A CLINICAL TRIAL?

• laboratory study
• animal studies
• clinical trials:Clinical trials are studies in
  patients which are generally designed to
  confirm the safety and effectiveness of a
  new promising treatment.
The trial design will be different depending on
  whether the drug is in early, intermediate or
  late stage of development.
   The Purposes of Clincal Trial

• To test different doses of the treatment,
• How often it should be taken,
• Whether it is best to take it is a tablet or
  injection,
• …...
    Drug Development Period
          and Expense

• Drug development period (from molecule to
  a drug in a pharmacy store) takes 3-10
  years.
• Drug prices are very expensive today
  because of high pre-clinical and clinical
  expenses.
   Drug Licence = New Drug Approval
• At the end of clinical trials, a government
  regulatory authority (department)
Sağlık Bakanlığı İlaç Eczacılık Genel Müdürlüğü in Turkey,
EMAE in EC countries,
FDA in USA  review all the results.
• If it is satisfied that the treatment is well
  tolerated and works in large number of
  patients, the drug is granted a licence (“new
  drug approval”) making it available to
  doctors.
 WHAT IS NOT A CLINICAL TRIAL?
• In 1932, a clinical trial named Tuskegee was
  conducted in patients with syphilis in USA. Study
  group comprised of 400 African-American poor
  men with syphilis. Control group was 200 healthy
  men. The doctors offered treatment without
  paying; but they only observed the patients
  without treatment during many years without
  telling anything. Ten years later, death rate was
  two-fold in the study group. Penicillin was
  developed in 1952. No patient was administered
  any antibiotics including penicillin until the end of
  study in 1972.
New York Times described this study as
“The longest clinical trial in human
 body without treatment in the
 medical history”
     May 16, 1997


                      Tuskegee trial



President Clinton apologised from USA citizens
because of Tuskegee trial
         The Willowbrook Study

• Willowbrook school was a government school in New
  York. Children with mental and motor retardation were
  educatied in this school.
• Hepatitis virus was injected in children between 1963-
  1966 so that to learn the natural progress of infectious
  hepatitis.
• Moreover, the school doors were closed to get new
  children during this trial. But if you would like to register
  your kid to this school, you should give permission him or
  her to enter this trial.
     WHY ARE CLINICAL TRIALS
          IMPORTANT?

• New treatments must prove to be safe and
  effective in scientific studies including a
  number of patients before they can be made
  widely available.
• These trials help us find new and better
  treatments.
      WHY WOULD A PATIENT BE
   INTERESTED IN A CLINICAL TRIAL?
• Usually they hope they will benefit. They may hope for a
  cure, a longer time to live, a way to feel better if they have
  cancer.
• They often also want to contribute to a research effort
  that may help others.
• The patients in a clinical trial are among the first to
  receive the new drug before they are widely available.
• All patients in clinical trials are carefully monitored
  during a trial and followed up afterwards.
• Treated within clinical trials, patients receive care from a
  special research team.
   ARE THERE RISKS OR SIDE
  EFFECTS IN CLINICAL TRIALS?
• Yes. Side effects vary from patient to
  patient.
• Patients need to know what side effects may
  be expected.
• Most side effects are temporary
• Some side effects can be permanent and
  serious, even life-threatening
• Certain side effects may appear later
 PATIENT SHOULD BE ELIGIBLE
     FOR A CLINICAL TRIAL

For example, eligible patients should
• Inclusion criteria:
  be less than 60 years old,
  have liver function tests in normal limits
• Exclusion criteria:
  not have acute infection,
  never been treated before
 WHAT IS INFORMED CONSENT?
• Informed consent is required in all studies.
• Doctor tells to a patient about the treatments
  being tested and gives the patient a form to read
  that discussed the risks and benefits in it. If patient
  agree to take part, he or she is asked to sign a
  form, called „informed consent form‟
• If a patient do not want to be in a trial, he or she
  may refuse. Signing a consent form does not bind
  the patient to the study. Patient can still choose to
  leave the study at any time.
WHAT PROTECTION DOES A PATIENT
   HAVE IN A CLINICAL TRIAL?
• The ethical and legal codes
• International Guidelines for Good Clinical
  Practice
  Institutional Review Board” (“IRB”=
  “ethics committee”), designed to protect
  patients, made up scientists, doctors,
  pharmacist (non-scientist), layman, and a
  jurist.
• Informed consent and insurance
       CONFIDENTIALTY

• All data collected on patient‟s health for the
  purpose of research will be kept
  confidential.
• Patient’s identity will never be disclosed.
WHAT KINDS OF CLINICAL TRIALS
        ARE THERE?
• Prevent, detect and diagnose, control and
  treat a disease
• Most clinical trials deal with new
  treatment approaches.
• These treatments often involve
  drug therapy,
  surgery,
  other kind of therapies.
HOW ARE TRIALS DIVIDED INTO PHASES?

Non-cancer Drug                Cancer Drug
• laboratory study             • tumour cell cultures
• animal studies               • animal studies
• clinical trials              • clinical trials
Phase I:                        Phase I, II, III:
       healthy volunteers              cancer patients
Phase II-III:
   patient with related illness

								
To top