The Task
• to profile a new drug from its initial discovery to clinical use.
• critically appraise the value and usefulness of the new drug, identifying its place in the range of treatment options available for the disease concerned.
The drug profile is to be written for an informed, intelligent, professional scientific reader. It is not intended for a lay audience or to be a patient information leaflet. The drug profile pro forma (next page) provides the outline structure of the report and some guidance on the information that should be provided in the different sections. The exact level of detail available for each section will vary between drugs but you should aim for an overall balance of content over the various sections; in the event of serious difficulties, you may turn to your supervisor for advice.
Writing a clear, concise and well-illustrated report is an important scientific and professional skill and you should use chemical structures, schemes and figures generously to help convey your meaning. A well-illustrated report should not exceed “20 pages in total. It is important that this is a coherent scientific document written in your own words, not a cut and paste patchwork job. As well as carefully selected and legible illustrations, there must be an informed commentary that conveys your understanding of the topic. 40% of the Profile mark is reserved for the critical appraisal of the topic. This should be an informed perspective on the significance of your drug (or its class) drawn from your reading, that will complement the factual content of the drug profile.
Things to consider might include:
• Is this class of agent being superseded by newer therapies?
• Are there new combinations under in clinical trials that may lead to wider application of the drug and / or improved patient benefit?
• Are there new applications to different diseases? (E.g. Thalidomide is in trials as an antiangiogenic agent for cancer treatment).
• Its is a “me too drug” – similar to an existing drug but offering little improvement in spectrum of activity or patient benefit?
• Are there improved versions of your drug in development? What is the timescale for them coming to the clinic?
• Is the clinical benefit sufficient to warrant use? Consider the controversy about the use of Avastin in the NHS. NICE’s conclusion was that it extended the life of colon cancer patients by only 6 weeks, so did not give value for money. The brain cancer drug Temodal, which may give up to two years good quality life, was initially rejected by NICE but the decision was reversed after pressure from clinicians, scientists and the charity Cancer Research UK.
• Do the benefits of drug use outweigh the side effects? Is quality of life more important that length of life?
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