ABC Company recently completed a multicenter, randomized, placebo-controlled, do
ID: 95799 • Letter: A
Question
ABC Company recently completed a multicenter, randomized, placebo-controlled, double blinded phase IIb clinical study to evaluate the safety and efficacy of one of its investigational drug product (XYZ Drug) in subjects with a rare disease. After reviewing preliminary safety and efficacy data from the phase IIb study, the decision was made to conduct a multinational phase III confirmatory clinical trial to support the marketing authorization application for XYZ Drug product.
1.Discuss the importance of conducting different clinical trials phases in the development of medicinal product for human use, and elaborate on the clinical development of biosimilar medicinal products as compared to that of innovative (or reference) medicinal products.
Explanation / Answer
clinical trials are experiments or observations done in clinical research.
such prospective biomedical or behavioral research studies on human participants are design to answer specific questions about biomedical or behavioral interventions including new treatments ( drugs , vaccination and medical devices).
clinical trial generate data on efficacy ( effectiveness ) and safety.
that is these are the two main goals of clinical trial.
examples of clinical trial along with importance.
1. on a specific kind of patient, for example a pateint who has been diagoned with alzheimer's disease.
importance - to check the efficacy ( effectiveness ) of drug on that particular disease.
2. at varying dosages, for example , a 10mg dose instead of a 5 mg dose.
importance - to check its effectiveness on increased dosages i.e check whether its effectiveness is increasing with increased dose or not.
secondly to check whether the higher dosages are safe for the patient.
3. for a new indication ( disease)
importance - to check how many diseases can be treated with a single drug.
4. evaluation for improved efficacy in treating a patient's condition as compare to the standard therapy. (importance is included)
5. comparision of two drugs in treating the same disease.
importance - to check which drug is better and safe.
BIOSIMILAR MEDICINAL PRODUCT IN COMPARISION TO INNOVATIVE MEDICINAL PRODUCT
a biosimilar is a biologic medical product which is almost an identical copy of an original product(innovative products) that is manufactured by a different company.
biosimilars are the officially approved versions of original "innovator" products , and can be manufactured when the original product's patent expires.