Types of Clinical Trials

Types of trials:

Phase I:

First time a new drug or regimen is tested on humans
Few participants (say <30)
Primary aims are to find a dose with an acceptable level of safety, and examine the biological and  pharmacological effects

Phase II :

Not too large (say 30–70 people)
Aim is to obtain a preliminary estimate of efficacy
Not designed to determine whether a new treatment works
Produces data in each of the trial arms, that could be used to design a phase III trial

Phase III:

Must be randomised and with a comparison (control) group
Relatively large (usually several hundred or thousand people)
Aim is to provide a definitive answer on whether a new treatment is better than the control group, or is similarly effective but there are other advantages

Phase IV:

Relatively large (usually several hundred or thousand people)
Used to continue to monitor efficacy and safety in the population once the new treatment has been adopted into routine practice.

Characteristics of a Good Case Report

Good case reports include the following elements:

1. Description of the adverse events or disease experience, including time to onset of signs or symptoms;
2. Suspected and concomitant product therapy details (i.e., dose, lot number, schedule, dates, duration), including over-the-counter medications, dietary supplements, and recently discontinued medications;
3. Patient characteristics, including demographic information (e.g., age, race, sex), baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors;
4. Documentation of the diagnosis of the events, including methods used to make the diagnosis;
5. Clinical course of the event and patient outcomes (e.g., hospitalization or death);
6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate;
7. Information about response to dechallenge and rechallenge; and
8. Any other relevant information (e.g., other details relating to the event or information on benefits received by the patient, if important to the assessment of the event).

Medical Dictionary for Regulatory Activities, MedDRA

The dictionary includes terms that are relevant to all phases involving man in the development and post-authorization safety surveillance of medicines and to the health effects of  medical devices (Maintenance and Support Services Organization).

The terms in MedDRA cover medical diagnoses, symptoms and signs, adverse reactions, therapeutic indications, the names and qualitative findings from laboratory, radiological and other investigations, surgical and medical procedures, and social circumstances. It  does not include a drug or device nomenclature, nor does it include terms covering study design, pharmacokinetics or patient demographics. It does not allow for adjectives such as those describing disease severity or frequency, although qualifiers such as acute, chronic, recurrent are included in terms when clinically relevant. There is a restricted range of terms for describing aggravation or exacerbation of medical conditions.

In the pre-registration phases of a product’s life cycle, MedDRA may be used, for example, for recording adverse events and baseline medical history in clinical trials, in the analysis and tabulations of data from these and in the expedited submission of adverse event data to government regulatory authorities. It may be used in constructing standard product information, such as summaries of product characteristics (SPCs) or product labelling and in registration files in support of applications for marketing authorization/new drug applications. After licensing, MedDRA is used in pharmacovigilance for the continuing evaluation of drug safety, for both expedited and periodic safety reporting

An Article on Pharmacovigilance in Vaccines

Here you go with the link on Pharmacovigilance in Vaccines -

http://www.ijp-online.com/article.asp?issn=0253-7613;year=2010;volume=42;issue=2;spage=117;epage=117;aulast=Budhiraja