Protocol Prohibited Medications in Clinical trials( How to identify from DM Perspective)

2017 WHO Drug User Group Meeting-BANGALORE Rajeswari Gopinathan

DISCLAIMER

– Information provided in this presentation does not contain any proprietary information; views expressed are those of the speaker and should not be considered official guidance. outlined are not organization perspective

I WILL SPEAK ABOUT….

Concomitant Medication in clinical trials

What is Protocol Prohibited list of Medications

How to identify it with coded data

Use of SDG

Challenges

CONCOMITANT MEDICATIONS IN CLINICAL TRIALS

Con-meds may interact with the study medication (thus leading to faulty conclusions regarding safety

and efficacy)

Drug effectiveness: Concomitant medications may also indicate a patient condition (like hypertension) which

potentially affects the pharmacokinetics of the study drug.

The Issues to be considered for contraindication, for inclusion on label or for further investigation in later

stage studies

Allowed drugs/Prohibited drugs: typically part of a clinical study’s inclusion and exclusion criteria.

WHAT IS PROTOCOL PROHIBITED LIST OF MEDICATIONS

A protocol prescribes the procedures to be followed during the study to ensure that the data that are being collected are

a good representation of the effect that the Investigational Medicinal Product (IMP) has. Therefore the protocol also

describes pretrial and concomitant medications whose use is prohibited because they are known to interfere with the

IMP or have an effect similar to that as expected from the IMP. Those Medications are so called Excluded/Prohibited

medications for that trial.

PROHIBITED MEDICATIONS FALL INTO THREE TYPES:

Drugs that interact with the study drug.

Drugs that diminish liver or kidney function, or otherwise raise pharmacokinetic or safety issues.

Drugs that produce confounding effects, such as masking or enhancing the intended benefits or potential side effects

of the study drug.

CONCOMITANT INTERVENTIONS- PROTOCOL TEMPLATE

Note: Prohibited medications descriptions in protocol will have list of medications, route and also time period of use. Instructions like discontinue them for at least how many number of days, Specific washout requirements etc.. Other instructions like Subjects who have previously received XXXXX therapy for any reason are excluded.

SOME METHODS TO IDENTIFY

Computer-Assisted Prescribing Programmed Pre selection

Concomitant Medication Monitoring System

Decision support system Drug interaction alerting system

CliniSafe

Coding Input

PROGRAMMED PRE SELECTION

Sponsor will send the list of Prohibited Medications. Coding of medications(Preferred term/ATC) SDG for reference Programmed Pre-selection Listing preparation Medical expert review/Manual selection from sponsor side Documentation of selected medications

SCENARIOS OF PROHIBITED DRUGS

Specific drug names sent/Preferred term

available in WHO DD

Categories of excluded medication that has corresponding SDG

Categories of excluded medication that can be linked to

an ATC code

Categories /drugs names that are not

available in the dictionary

Provide PT/code Provide the

SDGProvide the ATC code

corresponding SDG or ATC

code not available/

Contact Sponsor Medical expert

PROHIBITED MEDICATION LIST- (SAMPLE)

PROVIDING THE PREFERRED TERM

WHAT IS SDG

An SDG is any grouping of medicines having one or several properties in common

USES OF SDG

USES OF SDG

SDG USER GUIDE

SDGs 2016

SDG SUB GROUPS

SAS PROGRAMMING BASED ON PROVIDED PREFERRED TERMS

LISTING OUTPUT

ANALYSIS POPULATION MEETING

Sponsor/medical monitor, biostatistician & PK pharamacokineticist at a minimum will determine what protocol deviations may impact the final analysisAnalysis population meeting.

Analysis Population Template

CHALLENGES

Off label use Human error (coding decision went wrong)