Ophthalmology Clinical Trials

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Clinical trials are the experiments that involve the participation of human volunteers to find out whether a new treatment is safe, effective and superiority of the treatment. In Ophthalmology, clinical trials are mainly being conducted in the following therapeutic conditions:

  • Astigmatism
  • Cataracts
  • Conjunctivitis, Bacterial
  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • Eye Disorders/Infections
  • Glaucoma
  • Macular Degeneration
  • Macular Edema
  • Ocular Hypertension
  • Posterior Uveitis
  • Retinitis Pigmentosa
  • Sjogren’s Syndrome
  • Uveitis
  • Vitreous Hemorrhage

Ophthalmologists and Optometrists act as principal investigators in conducting clinical trials in eye diseases. Most of the ophthalmology clinical trials are randomized trials and sometimes include placebo in the control arm.  A placebo is a harmless substance or a dummy dosage form that resembles the real treatment but has no effect on the eye disease or disorder. In surgery or medical device trials, subjects in the control arm would receive sham treatment which has no effect on eye disease or disorder like a placebo. Continue reading

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Clinical Trials / Clinical Research in Tanzania

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In Tanzania, Health Research was started in 1897 by the incident of opening a laboratory by Dr. Koch, a German scientist. In 50 years of the country’s Independence, a lot has been done in health research, as reported by an official Newspaper.

In 1912, epidemiological studies were conducted by seven Germans, following an outbreak of sleeping sickness in the Northwest Tanganyika. A human Trypanosomiasis Research Laboratory was established at Tinde after the First World War. This led to the training of many medical assistants in many medical schools which were started after the laboratory. A Newspaper report states, “Prof. Lyamuya says that soon after independence, three enemies including ill health, ignorance and poverty were identified as key impediments to development in Tanzania.” Continue reading

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Introduction to MedDRA:

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MedDRA, the Medical Dictionary for Regulatory Activities, is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products. (Defined by MedDRA MSSO).

Big-Pharma used one or more available sources for medical terminology coding, like COSTART, WHO-ART, WHO-DRUG, etc., for many years. But in order to bring consistency and uniformity to the coded data being submitted to it, the FDA has recently committed to a standard coding dictionary namely, MedDRA. The ICH also mandates the use of MedDRA for safety reporting in clinical trials.

Most of the clinical trials are multi-centred and are being conducted in different geographies. To analyse the clinical data and to prepare the clinical study report using the data collected form different geographies, the collected data should be in a single format to avoid discrepancies. To avoid such discrepancies, coding of the medical terminology into a single universally accepted format is necessary. This can be achieved by using different medical dictionaries as mentioned above. But, FDA and ICH has mandated the use of MedDRA for medical terminology coding in clinical trials.

The Maintenance and Support Services Organization (MSSO), an organization that reports to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), manages MedDRA. The current version of MedDRA is version 14.1, which was released in September 2011. MedDRA version updates are released twice a year (March and September). The MSSO serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators.

MedDRA was classified into five categories from the broadest grouping found in System Organ Classes (SOCs) to the maximum specificity found in Lower Level Term (LLTs). The hierarchy of MedDRA is represented as follows:

 MedDRA hierarchy

The MedDRA is integrated with the clinical trial management software to enhance the autoencoding of the medical terminology within the system. Autoencoding systems typically use verbatim matching methods whereby a computer program attempts to assign a dictionary term (code) to the raw adverse event term based on matched spellings.
MSSO offers a desktop version of MedDRA for medical terminology coding. It is a beta version and can be downloaded from the MSSO website.

(http://www.meddramsso.com/subscriber_download_tools_browser.asp)

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Why Do Patients Participate in Clinical Trials?

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It is believed that a clinical trial is a partnership between a patient and a researcher that is based on trust and understanding. This is a partnership of peers, with both parties hoping for a favorable outcome that saves lives and bring on major changes in the field of medicine. At the heart of this partnership there lies trust from both partners; patients as well as the treating doctors or scientists.

There are many reasons to enroll patients, to start with is; to update them with an understanding of why clinical research scientists engage in trials, to ensure that patients are aware with research (via consents), to have advancement in science, and amongst the most important is to save lives.

A researcher should understand the patient’s trust and concerns when they are choosing to participate in trials. Understanding should be such that it lights the way to designing trials that will more stable in design and safe in application.

What patients need from a research while participating?

• To regain health, and retain to it as well.
• A patient with an attitude of refusal to surrender to their disease, will certainly try to put on a fight as such patients depend on a hope of revitalization.
• To have the satisfaction of knowing that a patient has done everything possible to fight the grave disease.
• To take advantage of a new treatment that may be inaccessible by any other way.
• Trust in the physicians and other staff who are conducting the research, while also having a faith that the clinical trial staff are working with the top experts in the field of the research.
• To contribute to the knowledge and well being of science and society, even though, it is learned that it may not be of personal benefit.
• For monetary gain may be, although for not all trials have this as major motivation.

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Biostatistics in Clinical Trials:

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Biostatistics an application of statistics is nothing but the science of the analyzing design and data of biological experiments, especially in medicine and related research. By definition, it is the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results.

Statistical analyses may be helpful in answering scientific questions brought to light while planning and executing a research. While planning for scientific question one should be ethical and valid. It should dictate both the design of the study and the analysis of the collected data.

To validate the research it should have a scientifically validated statistical plan. The role of biostatistician hence starts from commencement of research hypothesis and runs parallel to study progress. Sir R.A. Fisher says, “To call in the statistician after the experiment is done may be no more than asking him to perform a post mortem examination: he may be able to say what the experiment died of.”

The role of statistician is considered to be most complex and arduous task. Currently there are multiple regulatory agencies are planning to guidance documents and are in process to develop guidelines which will help statisticians to formulate a better statistical plan. Such steps will finally benefit the research world to develop more comprehensive R & D sector.

Statistics can never PROVE or DISPROVE a hypothesis, it only suggests to accept or reject the hypothesis based on the available evidences. Statistics can be a very useful tool to make decisions, but it should not be used only as a yardstick.

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