Clinical Research Trials

The Therapeutic Trials In Man

Welcome to Clinical Research Trials - When a new or old herb is predicted useful in man, then the time has come to test it in man. However it can take already a lot of time to test the herb in animals. So the herbs that are reported to have some adverse effects should be used in animals first and those ones in common use already should be studied in man.

Four Phases Of Clinical Research Trials

There is a planned way of introducing a new herb or drug for use in man. These are conventionally divided into four phases.

Phase One - Clinical Pharmacology:

• 20 to 50 persons are included in the herbal research.

• Healthy volunteers or patients are taken into the clinical trial.

• The biological effects, tolerance, safety and efficacy is studied.

• The absorption, distribution, metabolism and excretion is also studied where practicable.

Phase Two - Clinical Investigation:

• 50 to 300 persons are included in this advance study.

• Patients are accepted.

• Besides the above parameters, dose ranging, controlled studies are performed for efficacy and safety.

Phase Three - Formal Therapeutic Trials:

• In these randomized controlled trials 250 to 1000 people are taken in clinical trails.

• This provides the efficacy, safety and comparison on a substantial scale.

Phase Four - Post Licensing Or Marketing Studies:

• 2000 to 10,000 people are incorporated in these large scale studies.

• This surveillance is done for safety and efficacy, and further formal therapeutic trials and comparison with other medicines.

The above four phased studies are conducted for all the new drugs in Modern Medicine.  Only first two phased studies of  are conducted with reference to herbal clinical research trials. It is very rarely when the clinical research trials exceed the above level for herbal research.

Official Regulatory Guidelines For Clinical Research Trials In Man:

 These guidelines belong to modern drugs except some points.

1. The drug or herb is evaluated for its pharmacokinetics and bioequivalence i.e. how much is this medicine is available for beneficial effects after it absorption into the blood.

2. Various Therapeutic trials are adopted for the efficacy and safety.

3. Special groups of subjects - If the medicine is for some special group like the aged persons, females or pregnant ladies, then the agent should be studied in that group also.

4. Fixed Dosage Combination products should require full justification.

5. Interaction studies with other herbs or drugs or food articles should be considered.

6. The Countries where a license is required for herbs use (Product License, like in India, all new herbal formulations should be patented after clinical trials) should include a draft or Data Information Sheet for prescribers and for patients.

Only in some countries where herbal formulations are patented like in India after herbal clinical research trials, there are provisions for following the above mentioned criteria for herbal research. However some of the guidelines, that need a  lot of funds and practically not useful for herbal research esp. for herbs that are used traditionally for a long time, are not and perhaps should not be followed. In these cases only validation of efficacy and safety is fine.

Experimental Therapeutics Of Clinical Research Trials:

As more and more medicines are tested, the problem of who to test them grows. There are two main groups - healthy volunteers and volunteer patients. Some of the actions are demonstrable on healthy persons as anticoagulant and anesthetic action whereas some of the actions can't be shown on healthy persons as antiparkinsonian, antimicrobial effects. Besides using man as experimental subject offers some ethical problem.

Doctors or Experimental bodies should follow the principles of therapeutic evaluation. It is essential to know a good therapeutic study from a bad one. Both the good and bad studies are sometimes thrown on doctors by vested interests. Some times bad studies are replete with jargons of formal therapeutic trials what on close observation would prove to be a fraud. These principles are for the benefit of the doctor as well as all the patients and persons.

Therapeutic Investigations Of Clinical Research Trials:

These investigations employ two kinds of outcome. First one is the therapeutic effects itself e.g. sleep, freedom from infection etc. Second one is a factor related to the therapeutic effect or Surrogate effect e.g. blood glucose or lipid, blood pressure.

Studies involving surrogate effects are measured by studying large numbers of patients over years. They are not essential prior to release of new drug or herbal formula for prescription. For these conditions, surveillance studies are used to complement the formal therapeutic trials.

Therapeutic Evaluation Of Clinical Research Trials:

There are two ways to conduct - First Formal Therapeutic Trials or Experimental Cohort Studies and Second Surveillance Programs e.g. Case control studies, observational cohort studies.

The Formal Therapeutic clinical research trials are devised to find out the best of a drug can do under conditions ideal for showing efficacy - uncomplicated disease from mild to moderate severity. Sometimes these studies are also called Explanatory Studies.

The second Surveillance programs are desirable after the success of first one and are conducted to find out whether it can be successful and safe in the routine medical practice, in all patients, patients with complications, with other medicines etc.

Formal therapeutic trials are expensive and hard to conduct. Surveillance studies are less precise but compensate for this by convenience, large size and its closeness to ordinary clinical practice.

Formal Therapeutic clinical research trials are not able to reveal - uncommon adverse effects or those that occur after prolonged use, effects in special patients groups like elderly, pregnancy; unexpected therapeutic effects like new uses, and interactions with other drugs.

Conclusion:

Doctors should follow the scientific techniques to uncover the most effective treatments and should avoid the unethical course of notoriously depending on the clinical impression in both conventional and herbal research. It has been pointed out that where the worth of a treatment , new or old, is in doubt, there may be a greater obligation to test it critically than to go on prescribing it supported only by habit or wishful thinking. All the methods discussed above are powerful tools in advancing therapy if used judiciously and by knowing the conditions where they are fruitful and where to avoid them in Clinical Research Trials.

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The Preclinical or Animal Research trials - discovery to development of medicine - Its role in Herbal Research.

The Therapeutic trials  in Man - Its role in Clinical research trials of Herbal  Research.

How the Therapeutic Clinical Research trials are designed and What are the ethics of research in man? How are they sized appropriately?

What is double blind clinical research trials? Why are they necessary?

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