Clinical trials

Question 1

What is a clinical trial?

Answer 1

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product (s), and/or to study aDME of one or more investigational medicinal product(s)

Question 2

What is non-interventional trial?

Answer 2

Study with one or more medicinal products which have a MA , where the following conditions are met:

• the products are prescribed in the usual manner in accordance with the terms of that authorisation
• the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice
• the decision to prescribe a particular medicinal is clearly separated from the decision to include the patient in the study
• no diagnostic or monitoring procedures are applied ot the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question
• epidemiological methods are to be used for the analysis of the data arising form the study

Question 3

What is an investigation medicinal product?

Answer 3

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.

Question 4

Outline a clinical trial cycle

Answer 4

1. Investigator develops protocol for trial
2. Identify trial sponsor
3. Funding
4. Apply for eudract number
5. Apply of CTA and ethics
6. Apply for research approval
7. Carry out study in compliance with GCP
8. Notification of the end of the study
9. Submit report of study findings.

Question 5

What is the notification scheme?

Answer 5

For lower-risk trials. Defined as type A trials. In these cases the risk o the patient from the IMP is considered to be no greater than that of standard medical care.

Trials under the notification scheme also have simplified requirements for conducting the trial.

Question 6

What are type A trials?

Answer 6

Lower risk trials. The risk to the patient from the IMP is considered to be no greater than that of standard medical care. These are trials involving MPs licensed in any EU Member state if:

• the trial relates to the licensed range of indications, dosage and form of the product
• the trial involves off-label use that is established practice and supported by enough published evidence and/or guidelines

Question 7

A clinical trial involving patients is what phase?

Answer 7

Phase 2-4 (phase 1 is health volunteers only)

Question 8

what are the GMP requirements specific to IMPs?

Answer 8

Consistency between batches and adequate change control (some trials last >5 years and knowledge around a novel APID will grow over time)
Complexity with comparators and placebos randomisation
Incomplete knowledge of toxicity
Guidance on ordering, shipping and returning

Question 9

What must be included on an IMP label?

Answer 9

1. Name, address, telephone no, of sponsor
2. pharmaceutical dosage form, route of admin, quantity and for open trials strength/potency
3. batch/code to identify contents and packaging operation
4. trial reference code
5. trial subject id/treatment/visitor no.
6. name of investigator
7. directions for use
8. for clinical trial use only
9. storage conditions
10. period of use in a manner that avoids ambiguity
11. Keep out of reach of children