Related Experiment Video
Updated: May 30, 2026
07:02
A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
How Adaptive Trial Designs can Increase Efficiency in Psychiatric Drug Development: A Case Study
Joan Shen1, Sheldon Preskorn, Vladimir Dragalin
1Dr. Shen is Senior Director, Pfizer Inc., Collegeville, Pennsylvania;
Innovations in Clinical Neuroscience
|August 24, 2011
Summary
Adaptive trial designs significantly improve psychiatric drug development efficiency. This approach requires fewer patients and less time, making drug research more feasible.
Area of Science:
- Clinical Trials
- Psychiatric Pharmacology
- Drug Development
Background:
- Conventional clinical trial designs are often inefficient for psychiatric drug development.
- High costs and long timelines discourage pharmaceutical companies from pursuing psychiatric medications.
Observation:
- A recently completed study utilized an adaptive trial design.
- This design allowed continuous dose-response reassessment and early futility detection.
- Patients were randomized to one of seven drug doses, placebo, or an active comparator.
Findings:
- The adaptive design required only 202 patients to determine futility.
- A conventional design would have needed 450 patients for the same conclusion.
- This demonstrates substantial gains in efficiency and resource allocation.
Implications:
- Adaptive trial designs offer a more efficient and cost-effective approach to psychiatric drug development.
- Increased efficiency may encourage more pharmaceutical investment in this critical area.
- This methodology can accelerate the availability of novel psychiatric treatments.
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:28Drug Therapy
The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
Antianxiety Medications
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
01:26Psychosis: Goals of Pharmacotherapy
Antipsychotic drugs are a crucial treatment method for acute and chronic psychoses, bipolar illness, and behavioral disorders. The selection of these drugs depends on several factors, including the state of the disease, clinical judgment, possible drug interactions, and the patient's sensitivity to adverse effects. In immediate scenarios, such as delirium and dementia, short-term treatment with low doses of high-potency typical or atypical agents can effectively manage symptom exacerbation. For...