Medical Science

Clinical Research

Standards and Ethics

  1. We are basing our standards and ethics on the guidelines set out by the FDA for IRB's. However, we are going a step further to ensure the problems recently seen in with medication and the FDA approval process don't occur here.
  2. We are operating independent from any funding source. Since the 1990's the journal "Science" has repeatedly had articles warning about the impact of steering research to meet funding goals and targets. This warning has become all too real with the recalls of drugs, and hidden data showing problems.
  3. To deal with this problem different stages of research have different demands on patient monitoring.

    Stages of Research

    1. Basic Research - Prior to human application, basic research provides the underlying biological mechanism of the new medical science. Mechanisms that are studied in animals first. This is the point were biology meets medicine.
      Minimum Degree Requirement: PhD
      Minimum Duration: 4 years
    2. Medical Study The medical study is the first stage of study on a human patient and is based on the mechanisms and understanding developed from basic research. The medical study focuses on a single patient to develop procedure(s) and method(s) based on the basic research.
      Minimum Degree Requirement: DMSc
      Minimum Duration: 3 years
    3. Research list - this is a general list that allows patients to freely review medical advice specific to the research being done. This list acts as a portal for clinical study and proper patient screening.
      1. Copies of any research paper developed from list research must be filed with the IRB and have an open academic copyright.
      2. No patient from the list may be specifically referenced to. To ensure this patients (in the paper) must be refered to as patient A, patient B, etc. and use the pronoun (he, his, him, etc) refering to man the human not man the gender.
    4. Clinical Studies - clinical studies are medicals studies restricted to one patient in isolation from any other patient in the study.
      1. patients agreeing to come into clinical study should have been screened through the list and be prepared to provide medical records from their doctor(s).
      2. patients will have to agree to supply medical records for two years following the study to ensure that there are no prolonged negative effects.
      3. patient medical records must be properly maintained with both the IRB and the primary IRB contact
      4. Medical records (the new standard for studies, trials, and practice) must contain;
        1. Coverpage (Primay Information)
          1. name,
          2. email,
          3. Geographical location of patient,
          4. height,
          5. brief description of medical problem),
          6. brief description of clinical screening critria
        2. bi-weekly vital measurments (pulse, blood pressure, weight, temperature) and
        3. a reliable data set (monthly or better) of parameter measurements (cholesterol, blood suger, etc.)
      5. primary IRB contact(s) must have at least a DMSc
      6. Any negative effects, during or after the study, must be reported within 14 days to the IRB.
      7. Minimum Degree Requirement: MD[Defending]
      8. Minimum Duration: 2 years
    5. Clinical Trials - Clinical trials are trials of medical research on groups of 200 patients or more, with procedure clearly established in clinical study.
      1. patients agreeing to come into clinical trial should have been screened through the list or through a clinical study and be prepared to provide medical records from their doctor(s).
      2. patients will have to agree to supply medical records for two years following the trial to ensure that there are no prolonged negative effects.
      3. patient medical records must be properly maintained with both the IRB and the primary IRB contact
      4. primary IRB contacts must have at least a MD[Defending]
      5. Any negative effects, during or after the trail, must be reported within 14 days to the IRB.
      6. All Patients must be monitored throughout all phases of the clinical trial
      7. Minimum Degree Requirement: MD[Defending]
      8. Minimum Duration: 2 years per phase
      9. Phases;
        1. Initial phase has 200 patients
        2. This phase adds 100 patients to those in Phase I
        3. Phase III adds 150 (50% of 300) patients to the total number of patients in the study
        4. Phase IV adds 225 (50% of 450) patients to the total number of patients in the study
        5. The final phase adds 425 (675 patient + 425 new patients = 1000 patients) patients to the total number of patients in the study
    6. Clinical Use Study - This is a new phase to follow medical research from clinical study into clinical use. After the failures of Vioxx and Celebrex, it's clear the this step is needed.
      1. patients agreeing to come into clinical use study should have been screened through the list, clinical study or through clinical trial. As well, they should be prepared to provide medical records from their doctor(s).
      2. patients will have to agree to supply medical records for two years following treatment to ensure that there are no prolonged negative effects.
      3. patient medical records must be properly maintained with both the IRB and the primary IRB contact
      4. primary IRB contacts must have at least a MD[Defending]
      5. Any negative effects, during or after the treatment, must be reported within 14 days to the IRB.
      6. Minimum Degree Requirement: MD[Defending]
      7. Minimum Duration: 2 years per phase
      8. Phases;
        1. Initial phase has 200 patients
        2. This phase adds 100 patients to those in Phase I
        3. Phase III adds 150 (50% of 300) patients to the total number of patients in the study
        4. Phase IV adds 225 (50% of 450) patients to the total number of patients in the study
        5. The final phase adds 425 (675 patient + 425 new patients = 1000 patients) patients to the total number of patients in the study
  4. The goal of the phases is to provide fixed term comparisons of 2, 4, 6 and 8 years of, in trial, research information and effectiveness. New (incoming) patients, in each, phase can (and will) be compared to those already in the study. Such standards can reveal and prevent serious problems caused by a drug or procedure.
  5. The period of placebo ranges from 6 to 12 months. The 2 year (24 months) standard provides for a study time of 4 times the placebo period. The standard "double blind" method of clinical trial, which has been the standard for years, has been shown to be flawed. The failures of Vioxx and Clebrex demonstrates this failure. However, proper application of this method has no such failure mechanism. The reason has to do with the body's unusual placebo response. Placebo studies done here, via research lists, has found that placebo behavior can be identified (easily) within a two year period. Medication, even in a double blind study, can have a placebo effect. This effect was seen to exist for a typical period of 6 month (but under some conditions - but rare - seen to last for up to 12 months) before the medication was no longer effective and was changed. [Placebo study was/is based on more than 10,000 points of data.]
  6. Degree Standards
    1. PhD - is simply the Philosopher's Degree and achieving this degree depends on philosophy.
      1. The philosophy, of the degree granting institution, determines how a PhD is granted.
      2. All universities are schools of philosophy and have a philosophical base from which they teach.
      3. All universities (except for Akadhmia University) are based in a subjective philosophy - where the philosophy of the candidate must be approved and accredited.
      4. However, since science is supposed to be objective - then objective philosophy must exists (this was the PhD thesis - http://deltard.org - and is now the theory). Akadhmia University , based solely on objective philosophy, was developed as an aspect. Under objective philosophy, the school cannot approve or disapprove a philosophy of a PhD candidate - that's the function (job) of the candidate to demonstrate the objectivity (validity) of their thesis. As such, our standard of granting degrees is different - so long as a thesis has been presented, (see standards at http://grad.akadhmia.org) then a PhD can be granted and the candidate must defend it.
      5. The PhD and the post-doc period - The post-doc period is time, after the degree has been granted, that they have to demonstrate that their thesis is a theory - an objective theory. This period typically lasts about 4 years.
    2. DMSc - is the degree, Doctor of Medical Science and can only be claimed by a medical scientist after the post-doc period.
    3. MD
      1. [Defending] - This designation is similar to the post-doc period of the PhD. It's designed to allow the new MD to defend his qualification and build reputation. The determination to apply this designation to the DMSc depends entirely on the rate medical research moves from basic research into full clinical study.
      2. [GP] - general practitioner; A general practitioner is the standard licensed doctor that most people know and because they typically have no research background don't qualify to oversee medical research.
      3. [Sci] - Scientist; is the MD designation of a DMSc after the [Defending] period is over.
      4. [surgical] - Surgeon; A MD with surgical training