Clinical Trials: Development of New Psychotherapeutic Drugs Flashcards
Translational research
Research designed to translate basic scientific discoveries into effective clinical treatments
Clinical trials
Studies conducted on human volunteers to assess the therapeutic efficacy(werkzaamheid) of an untested drug or other treatment.
Clinical trials are conducted in three separate phases: (1) screening for safety, (2) establishing the testing protocol, and (3) final testing.
Screening for safety phase 1
- Determine whether the drug is safe for human use and how much of the drug can be tolerated.
- Clinical trials with tiny injections, gradually increased as the tests proceed.
Establishing the testing protocol phase 2
- Establish the protocol (the conditions) under which the final tests are likely to provide a clear result.
- Conducted on volunteer patients suffering from the target disorder;
- Tests usually include placebo control groups, and their designs are usually double blind—that is, the tests are conducted so that neither the patients nor the physicians interacting with them know which treatment (drug or placebo) each patient has received.
Final testing phase 3
- Double-blind, placebo control study on large numbers of patients suffering from the target disorder.
- Design based on the results of phase 2 so that the final tests are likely to demonstrate positive therapeutic effects if they exist.
- In most cases, two independent successful tests are required to convince government regulatory agencies. A successful test is one in which the beneficial effects outweigh any adverse side effects.
Requirement for double-blind design and placebo control –> controversial aspects of clinical trials
- Some patients whose only hope for recovery may be the latest experimental treatment will, without knowing it, receive the placebo.
- However psychiatric disorders often improve after a placebo, a doubleblind, placebocontrol procedure is essential in the evaluation of any psychotherapeutic drug.
The need for active placebos –> controversial aspects of clinical trials
- Participants in doubleblind, placebocontrol studies can feel the side effects of the drug and know they’re not in the placebo group. –> This can contribute to the positive effects of the drug, without any real therapeutic effect.
- Active placebo is better than an inert placebo
Active placebo
Control drugs that have no therapeutic effect but produce side effects similar to those produced by the drug under evaluation.
Length of time required –> controversial aspects of clinical trials
Patients desperately seeking new treatments are frustrated by the amount of time needed for clinical trials –> Striving to speed up the evaluation process without sacrificing the quality of the procedures designed to protect patients from ineffective or dangerous treatments.
Financial issues –> controversial aspects of clinical trials
- Millions are spend conducting these trials and often don’t go through phase 1 –> PROBLEM sponsoring drug company makes scientist sign an agreement that prohibits them from publishing or discussing negative findings without the company’s consent.
- Orphan drugs
- Translational bottleneck
Orphan drugs
Drugs for which the market is too small for them to be profitable.
Translational bottleneck
Only a small proportion of potentially valuable ideas or treatments receive funding for translational research.
Targets of psychopharmacology –> controversial aspects of clinical trials
- Most psychiatric disorders, are likely clusters of disorders. Effective new drugs are likely to benefit only a proportion of those patients who have been given a particular diagnosis, and thus their effectiveness might go unrecognized.
Relative effectiveness of clinical trials
Clinical trials can be trustworthy, fast, or cheap; but in any one trial, only two of the three are possible. Think about it.
