Clinical Trials - Process

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Written by Vanessa Jones, B.A  | Medically Reviewed by Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond) on Oct 31, 2016
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What happens during a clinical trial?

There are various stages in a Clinical Trial. They are as follows:

  1. Drug Development and Approval process
  2. Clinical trial Protocol
  3. Patient Enrolment
  4. Analysis of results
  5. Publication of results
  • Every Clinical Trial is unique in its own way and is designed in such a way so as to answer the specific reasons for which the trial is being done.
  • A "protocol" or Trial plan maps out what study procedures will be done, by whom, and why.
  • The clinical trial team consists of doctors and nurses as well as other health care professionals who monitors the participants health during the various stages of the trial once the patient has been found eligible to participate in a particular study.
  • Patients are initially identifed by a process know as SCREENING where Investigators identify possible Participants by investigating if they meet the Clinical Trial Inclusion and Exclusion Criteria.
  • Once a participant has been found suitable for the trial, the investigator explains to him about his role in the trial and also about the benefits and risks associated with the same and the participant is then asked to sign an informed consent form, giving his/her consent to participate in the trial.
  • On signing the Consent form, the study procedure starts and the participants are enrolled. After the enrollment process the Participant goes through an initial set of tests/procedures and if still meeting the criteria for the study is provided with instructions and the Study Treatment and given review dates.
  • Participants are monitored and carefully assessed during the trial as well as after it is completed.
  • Clinical trials are usually done at hospitals and are conducted in phases (I, II & III).
  • After a phase I or phase II trial is completed researchers analyze the data collected and make a crucial decision whether to: Move on to the next phase of the trial (Phase III) with the treatment, or to stop testing the drug / treatment because it is not safe or effective.
  • If any harm has come to patients, (bad drug reactions for example) the trial may be stopped early.
  • Trials can also be closed early if the new treatment is giving much worse results than the standard treatment, in such conditions patients on the new drug or treatment will be immediately switched to the standard treatment.
  • After phase III trials are completed a complete analysis of all three phases are done and researchers decide if the results have any significant medical importance and publish their results in scientific or medical journals where experts review the report before it is published, to make sure that the analysis and conclusions are sound.
  • Results for several trials of the same treatment may be analysed together and published. This is often called a 'meta-analysis'
  • Once a new drug or intervention is proven safe and effective in a clinical trial, it may become the new standard of practice.

Clinical Trials - Reference

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Hello I’m the son of a Cancer patient. I’ve 2 boxes of Inj Iscador available for cancer treatment which I could not use for my father. Iscador is a recognized therapy for Cancer treatment to balance the side effects of Chemo and other standard treatment options. Researched and manufactured in Europe, the Injections are normally prescribed by most Cancer specialist Homeopaths and a few Oncologists. These injections have to be taken regularly over a period of 2-3 months for the desired effects. But one can consult a fellow Homeopath for the exact medications. In India, these inj have to be imported from Waleda and are available only at a few select places. The available medications are 2 boxes each of Iscador Q Series 0 and 1 @ Rs. 4500/- per box. Please read : http://www.iscador.com for more details. Also consult Dr. Kasad [Mumbai] or Dr. Navneet Rastogi (Delhi) for more info. Mail me : sniphadkar@gmail.com for more details

I want to start a cancer support group here at a village near Madurai, to conduct free medical check-ups, guide cancer patients like where they to go for treatment, whom to contact, how to go there, where they can get free treatment or where assistance could be got etc. Those who are already doing this kind of help to cancer patients can please guide me how to run a similar cancer support group in this village near Madurai. Please contact Gurumoorthi, thanks.

guest

We are a group of anti- cancer healers and counsellors , our mission being , allow the fullest co-operation of the patient with the Specialists/Physicians for reducing the side-effects, reduce pains , ease digestion etc. All that we need is a photogragh of the patient and theh details of treatments and updations to our mail i d. Don belive us until you see the effects of our hard work . 'Service to patients with big C is service to God ' our motto .

guest

my dad has been diagonised with stage 3 lung cancer he is undergoing radiation n chemo he is 63 years,please give me some tips about what has to be done treatment was started on 2nd august 2010.

guest

What are the side effects that occur as a result of the new treatment/ drug

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