INFORMATION ON CLINICAL TRIALS

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A COMPREHENSIVE INFORMATION ON CLINICAL TRIALS

Clinical trials are research studies performed in humans with aim of evaluating medical, surgical, or behavioral interventions involving new treatments such as drugs, vaccines, and medical devices. 

Clinical trials generate data on safety and efficacy. 

EARLY STORIES:

• It was in 605 BC Daniel set out to test the Effects and Benefits of Vegetables   by eating it for 10 days and other people enjoyed eating meat and wine .After ten 10 days who was healthier between the two groups were assessed.

• Hippocrates (460-370 BC) Known as father of medicine laid disciplines required to carry out a clinical trial. Today the graduating physicians are reminded of Hippocratic Oath to practice medicine properly and ethically.

• During fifteenth century a French barber surgeon Ambroise parѐ performed an unplanned comparison of treatment in battlefield wounds. He compared one group of patient treated with boiling elder oil and remaining with a recipe made of egg yolk, rose oil, and turpentine. Pare found that the soldiers treated with oil were in agony and the ones treated with ointment had recovered due to antiseptic properties in turpentine oil. 

• Later in seventeenth century a Scottish physician James Lind performed the first ever clinical experiment named Cure of scurvy through citrus fruits. He compared effects of different acidic substances like cider, sulfuric acid, vinegar, seawater, oranges, lemons and spicy paste with barley water on groups of sailors and concluded that the group which was treated with oranges and lemons had immediate positive effects.

NEED FOR CLINICAL TRIALS:

Clinical trials are essential for the development of new medical treatments and diagnostic tests. Without clinical trials one cannot properly determine whether the new treatments which are developed are safe and effective. So by performing clinical trials one can test and monitor the effects of treatment in large number of patients to rule out improvements and unwanted effects. 

ETHICS:

The purpose of ethical guidelines is to promote both patient safety and and preserve integrity of science. The ethical guidelines placed were primarily due to past abuses. 

ICH-GCP is a harmonized standard that protect the rights, safety and welfare of human subjects .Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirements. 

The following guidelines are represented below:

PHASES OF CLINICAL TRIALS:

Once the FOOD AND FRUG ADMINISTRATION (FDA) approves the Investigational new drug application (INDA) the Clinical testing of drug is began ensuring safety of human volunteers through institutional review board (IRB).

Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and includes four phases.

  CLINICAL TRIAL PHASES

PHASE I:

Also known as First In Human Study is done on healthy volunteers ranging from 20-100 subjects with duration of several months.

This study is designed as open-labeled or blinded study which aims to assess safety and tolerability, pharmacokinetics (A, D, M, E) and pharmacodynamics (EFFECTS) of a drug.

PHASE II:

Also known as Therapeutic Exploratory Studies .Phase II studies are single blinded, placebo controlled studies that evaluates potential efficacy and characterizes treatment benefits. It determines dose range and medication regimens use in phase III.

Phase II studies are divided into two types:

Phase IIA: In this a pilot study is conducted to assess efficacy and safety of drug on selected population to understand dosage frequency and dose response. 

Phase IIB: A pivotal study which evaluates safety efficacy of study drug. This phase is carried out on human volunteers ranging from 100-300 for around 1-2 years. 

PHASE III:

Also known as Therapeutic Confirmatory Phase.  It is a randomized controlled multicentric study which is done in larger population (1000-3000). It acts as a pre-marketing phase of clinical trials and is expensive and time consuming.  It assess effectiveness of new treatment with that of standard treatment.

Phase III clinical trials are divided into phase IIIA which are trials done after the efficacy of therapy is demonstrated but before regulatory submission of a New Drug Application(NDA) and phase IIIB which are conducted after submission of a NDA but before approval and launch. 

PHASE IV:

Also known as Post Marketing Surveillance studies (PMS). The focus of the trial is on how drugs work in the real world. Efficacy and detection of rare or long term adverse effects over a much larger population and longer time period are evaluated. Phase IV trial may result in a drug being removed from the market or restricted to certain indication.

CONCLUSION:

By understanding the steps and improving developmental strategies and studies and availability of drug to general population will result in better patient outcomes and fewer morbidities.

                                                                                         By:---

                                                                                         Saira Arsheen  

                                                                                        MD.Arif Khan