FAQ

1. What are the advantages of CogState Research over paper and pencil testing?

Paper and pencil tests are particularly useful when assessing the pattern of cognitive abilities that might be impaired by a disease or intervention. However, they often require highly trained administrators to conduct and score the test. While this helps to ensure correct administration of a test, administrator/scoring bias cannot be avoided. When part of a clinical trial, paper and pencil test data often needs to be entered manually into the CRF, introducing the additional risk of transcription errors (estimated to occur in some trials in up to 30% of data). Furthermore, times recorded by administrators during paper and pencil tests are usually restricted to seconds. Computerized testing in clinical trials can offer a more reliable test (such that retests get similar results) by reducing human errors in data recording, observer bias and transcription. Administration can easily be standardized allowing non-expert supervisors. Reaction times can be recorded in milliseconds and data are saved and securely transmitted to DataPoint® (CogState's secure upload website) with no requirement for entry of the data into the study CRF.

2. Why are CogState tests significantly faster than competitor tests?

CogState tasks are designed and optimized to collect as much data about performance (i.e. speed and accuracy) in as short a time as possible. Each task uses a single trial to collect one data point (or observation of a subject's response) in a few seconds and then repeats this trial multiple times (using randomization as much as possible). In 1-2 minutes, 30 or more observations can be obtained, which is sufficient for detailed statistical analyses. This allows CogState batteries to sample multiple cognitive abilities in minutes. Many other tests gain only one or a few observations after minutes of testing, and hence their batteries may require many minutes or even hours to sample multiple cognitive domains.

3. Who can administer CogState ClinicalTrials?

CogState ClinicalTrials is administered by a computer and requires only supervision. This test supervisor can be anyone who has completed the brief CogState training workbook. Prior neuropsychological assessment experience is not necessary. CogState places great emphasis on comprehensive training so that members of site staff are fully equipped to use the testing system and supervise the study subjects.

4. What can you tell me about the scientific validity of the tasks in a test battery?

Each CogState test has been through a full development process to confirm its face validity, construct/criterion validity, reliability and sensitivity to cognitive change as a result of intervention (drug) or disease progression, or indeed to no change in the absence of these circumstances. Research using CogState batteries has been published in over 100 peer-reviewed journals. Each test has been developed with specific requirements in mind to ensure sensitivity to specific cognitive abilities.

5. Which tasks should I use?

The correct battery for your trial depends upon your study design, population and indication. CogState prides itself in being flexible and meeting the needs of your individual trial. To this end, there are pre-defined batteries of tasks that we have found to fulfill specific trial types and needs - e.g. early phase trials where speed and global screening is required, or schizophrenia trials where the battery must test those domains defined by the MATRICS group. However, many of our customers build their own study-specific battery using any number of our tasks in any order - the choice is yours.

6. How often can I test subjects?

The CogState tasks are designed to be rapid and repeatable. Since they involve multiple trials within each task, practice effects are rapidly minimized. Hence, they can be repeated as soon as the test is completed, if required. One example is in acute dosing studies. An initial baseline battery can be done pre-dose (taking for example 8 minutes) followed by a shorter battery (which might just include attentional tasks taking 1-3 minutes) performed every 5-10 minutes over the next hour, followed by the full battery at 30 minute intervals. Commonly in phase I studies of a drug with a short tmax up to 8 CogState batteries can done on Day 1 without interfering with the other important safety assessments. We believe the testing situation should determine the frequency of testing, rather than the test itself. Our tasks are flexible enough to meet a wide range of different trial requirements.

7. How do I send my results?

The best way to send in your results is through our online data management system - DataPoint®. DataPoint® is a powerful, internet-based web browser-compatible application that allows sites to upload the test data directly to the CogState database and then immediately review what was sent. It also gives study sponsors access to the data in real time for monitoring and review. DataPoint® supports international multi-center clinical trials by allowing data transfer from anywhere in the world via the internet in real-time at a central, secure, web-based location. Alternatively, if your study site does not have internet access, study data may be saved on USB memory sticks and sent directly to us for uploading to DataPoint®.

8. Is my data secure?

Data files are stored as encrypted files locally on the testing computer. Only when the data is uploaded to DataPoint® is the data decrypted. Therefore study data is inaccessible to anyone who may have viewing rights to the testing computer, only nominated users of DataPoint® can access the decrypted data. All data storage and transfer protocols are compliant with FDA 21 CRF part 11.

Data files that are uploaded to DataPoint® are stored in a physically secure data warehouse, and backed up immediately, daily and then on a weekly basis. Data files are backed up on and off-site to ensure security. Once your trial ends, data files are removed from the DataPoint® servers, and archived securely for a minimum of 7 years.

9. What statistical analyses are best?

Analysis of CogState task data usually uses pre-defined primary outcome variables. Although many hundreds of parameters are able to be computed from the many data points of a typical data file, only some are recommended as primary outcome variables. These are performance based parameters assessing speed, accuracy or variability that have been shown to be sensitive to change and stable over time in serial testing. different tasks exhibit different primary outcome measures, for example, of all the possible outcome measures for the Detection task (measuring simple reaction time) the speed measure is most sensitive to cognitive change, whilst the accuracy measure has proven to be most sensitive for the One Card Learning task In addition, we make every effort to use parametric rather than non-parametric statistical analyses. For this reason, we recommend reaction time data is log transformed, and accuracy scores arcsine transformed to make them approximate normal distributions. Thereafter, powerful statistical techniques are possible. The specific statistical analyses that are appropriate for your study will depend upon the design (e.g. how many control and active arms, cross-overs). Our scientific staff is very happy to discuss such issues with you to optimize your trial's analyses and contribute to your statistical analysis plan if required.

10. Who owns the data at the completion of a trial?

CogState ClinicalTrials is a tool to collect data from your study subjects on your behalf. CogState makes no claim to the data itself, either during or after a trial. All data collected belongs to the trial sponsor. CogState will not use any data for non-trial purposes without the express permission of the customer.

11. What points should I include in ethics applications?

Ethics applications commonly require a description of the instruments to be used in the trial. These may need to be customized with the inclusion of new or relevant studies to the area of the trial's interest. If you need some specific information for an ethics or IRB proposal, please ask your dedicated project manager.

12. Can I get reports for individual participants?

Reports which contain the serial test data of individual participants are available on DataPoint®. These are useful for safety monitoring, where an independent person can be given access to these reports online to allow them to monitor progress or review specific individuals. In addition, some trials include reports to participants for individual feedback. If you need this facility, please ask your dedicated project manager.

13. What if I want to do an academic study?

CogState has developed a product called CogState Academic, which gives academic researchers access to the same tasks as those included in our clinical trial batteries, but at a significant discount. We suggest you visit the CogState Academic section of our website for more information. Here you can find out more about the criteria you must satisfy to qualify for our academic product and pricing.

14. Are the tests approved by the FDA?

The FDA does not approve specific test instruments. In some circumstances, the FDA will recommend (or mandate) certain assessments for specific medical conditions or therapies (such as the CIBIC in Alzheimer's disease). Tests that are presented to the FDA as part of regulatory submissions must be able to satisfy the FDA that they are informative or an accepted standard in the area(s) investigated. Scientific validity is important and this includes peer-reviewed publications and track record. In addition, adherence to quality procedures are important to ensure standards are high. Our tasks have been presented already in submissions before the FDA, and our procedures satisfy regular pharmaceutical company audits, FDA 21 CFR part 11 and ISO-9000 standards.

15. Can visually impaired subjects complete a test battery?

Some forms of visual impairment may not be a problem. A person with color blindness can usually discriminate the different card stimuli by other cues. A person with reduced visual acuity might be able to be tested, so it is usually worth trying them out on the battery required. If they can "see" the stimuli, then even if they are a bit slower than average, testing will still be possible as most trials will be comparing them to their own baseline performance. If a subject usually wears glasses he/she should also ensure they are wearing them when performing the battery.

16. Can hearing impaired subjects complete a test battery?

The tasks use sounds to provide feedback when correct responses are made, or errors occur. The feedback sounds are helpful to learn tasks quickly and monitor for errors, however, they are not essential. Visual feedback also occurs and this can be used to interactively monitor performance. If a subject usually wears a hearing aid he/she should ensure they are wearing it when performing the battery.

17. Can severely impaired subjects be tested?

In this context, severely impaired usually refers to severe cognitive impairment. In general, the CogState tasks are designed to be used when administered by the computer with minimal supervisor interference. Clearly this favors healthy or mildly impaired individuals. Persons with severe cognitive impairment generally cannot do computer tasks by themselves and will require supervisor assistance. Nevertheless, if supervisor assistance is integral to the trial design, CogState tasks can be used, and simple customizations included to help test difficult (e.g. distractible, psychotic, depressed) or impaired patients. We will discuss such customizations that might be applicable to your study population with you before your test battery is confirmed to ensure above all else that a computerized tests is indeed the right choice for your trial.

18. Who supplies the equipment required for a clinical trial?

The CogState tasks will run on almost any current hardware. If computers exist at a trial site, then these can be used. If there are no computers available and the customer would like pre-installed software, then CogState can arrange to provide pre-installed computers ready for the trial.

19. What happens if I encounter a problem during a clinical trial?

Contact us. We offer 24 hour technical support 7 days a week and we will deal with any problems that might occur quickly and efficiently.

20. Can we audit CogState?

Yes - we welcome audits as they help us to continuously improve our products, services and processes. We have been successfully audited in the past by everyone from major pharmaceutical companies to independent consultants in order to ensure that we are fully compliant with applicable FDA and ICH GCP regulations.