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clinical trials

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    During the past fortnight, Solagran (SLA) has been gaining a little market recognition, and its share price moving forward.

    This has happened entirely on the back of speculation, however, because the company has yet to reveal what its ongoing “Bioeffectives” research program (totalling more than 3 million PhD man-hours and arguably the largest-ever botanicals research program) might have produced.

    There is, I believe, exciting news coming soon - and others who follow the story have hinted broadly at one focus being liver research.

    I wonder, though, how well equipped many people reading these posts are to gauge just how exciting (or otherwise) an announcement in the area of pharmaceuticals research is.

    Not too many, I suspect. I know I have found myself deficient in this regard. So I have set about learning some of the basics, and I am happy here to share with you if you have an interest.

    One aspect I figure is important from an investment viewpoint is judging how advanced the research is. The objective test: How far have human clinical trials progressed?

    Types of Clinical Trials

    When a drug company develops a new medication, the process starts in test tube and animal studies. These studies give researchers an idea of how well a medication works and what kind of side effects it might have in humans. If the results of early studies look good, the drug company designs and pays for clinical trials to test the medication in humans. These trials are divided into three stages, which are known as Phase I, Phase II, and Phase III trials. Here’s how they break down:

    PHASE I TRIAL - The first stage in testing a new drug in humans. The studies are usually done to gather preliminary information on the chemical action, dosage and safety of the drug using healthy volunteers. Usually done without a comparison group.

    The question asked in Phase I: ‘Is the treatment safe?’
    Risk: Highest – First trials in humans; used to determine best dosages.
    Duration: Shortest – A few weeks to a few months.
    Number of participants: Few.

    PHASE II TRIAL - The second stage in testing a new drug in humans. Performed in patients with the disease or condition being studied. The main purpose is to evaluate the activity of a drug, and to possibly provide information on how well the drug works.

    Question asked in Phase II: ‘Does the treatment work?’
    Risk: Moderate risk - Some safety information about the drug is known.
    Duration: Medium length - Usually about a year.
    Number of participants: About one hundred participants.

    PHASE III TRIAL - The third and usually final stage in testing a new drug in humans. Used to collect information about the safety of a drug and how well it works. Once this phase is complete, the drug manufacturers may request permission from the relevant authority to market the drug.

    Question asked in Phase III: ‘What are the long-term results in lots of people?’
    Risk: Lowest Risk - More information about safety and effectiveness is known.
    Duration: Longest - May last for two to three years.
    Number of participants: At least several hundred participants.

    PHASE II/III TRIAL - Sometimes, Phase II and III trials are combined into a Phase II/III trial. This speeds up the process of gathering information.

    When all three phases are complete, the information from the trials is submitted to the drug approval authority (eg., TGA here; FDA in the US). The authority reviews the information, and then approves or rejects the new medication. Sometimes more information or further trials are requested before making the decision.

    So endeth the lesson.

    It is rare that a research program comes to the market fully formed, like Athena from the head of Zeus. However, as a private company, Solagran has been quietly beavering away for a number of years. Now that it has listed, its shareholders may well be pleasantly surprised by the extent of its advancement.
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