At DCC, we have worked with a number of clients for a range of different clinical trials. The purpose of a trial is usually to test the safety and efficacy of a drug, either to improve upon a drug already available or to provide an alternative treatment with comparable effects and methods of action. Clinical trials also monitor the performance of certain therapeutic protocol; test a hypothesis or a new device.
Every clinical trial study has its own eligibility criteria that dictates who will be involved in the testing. If the trial is the study of a particular disease, patients suffering may be involved; a more generic testing of a drug/protocol will make the general populace eligible (once medical criteria are met). It is not always necessary that humans are involved; plants, cells, animals or even non-living entities may be subjects of a clinical trial.
An overview of the process
Each trial will go through feasibility testing; as the name may indicate, this is an assessment of the risks and costs associated with the trial. Following this will be a pilot study involving a small sample size, which is typically increased throughout each subsequent phase. There usually four or five phases to allow the principle and chief investigator to further understand the risks involved and whether the trial can continue. Each trial will have at least a sponsor or funder, usually an organisation who will benefit from the results gained from the trial.
You may be wondering what a data capture company has to do with science. Science houses data, and lots of it. Depending on the size of the clinical trial, involvement may range in the hundreds or thousands. Data will be collected from the following, depending on the study:
- Case/Clinical Report form (CRF): The CRF contains information on patients participating in a clinical trial and collects data from each site that is participating.
- Patient Report form (PRF): Patient report forms collect information of participants.
- Consent forms: These forms are given to each participant, as their consent to participate must be documented.
- Ethics forms: Every trial requires ethical approval.
From our experience of working with professors and doctors in previous clinical trials, we find the major pain point is within Clinical Report Forms, or CRFs. These must be submitted to the sponsor of the trial and the typical issues that often arise include:
- Matching the CRF data with the subjects’ medical records
- Writing clearly, accurately and legibly
- Ensuring consistency throughout each page on the CRF
- Staying within margins identified by the constraint field
- Amendment of incorrect data
- Inconsistent formats of certain data types, such as date fields
It is understandable that Principle Investigators are highly passionate about the subject they are researching and cannot afford time to be wasted on administrative tasks. In some instances, University professors task their PhD students with data collection and submissions; frequently, this leaves them performing menial tasks rather than furthering their own studies and research projects.
At this point, our own expertise can take this pain off your shoulders. Our team of experts are able take your existing CRF and overlay your existing fields with capture fields. These contain certain validations and processing rules that uphold accurate, clear data. For example, fields such as dates, numeric values and other fields following a rigid structure can be validated; this means that when our team of verifiers scan each CRF, our software will flag up data that does not follow the correct structure. A date written with an American format rather than the UK standard, or a date written out in words rather than numbers can therefore be amended rapidly where possible. In cases where handwriting may be difficult to read, the highly accurate software will display recommendations, and our verifiers can make the amendments with common sense applied.
Once we have performed our verification and quality checks, data can be directly exported into any system or database that sponsors may be using. This can help to save time that would otherwise have been spent manually entering and submitting data.
If this sounds as though it could be of interest, we typically offer an educational knowledge-sharing workshop at no cost that can be held at your premises. This provides further, in-depth knowledge from our project managers on how they have supported previous clinical trials.
We have added value to previous studies and we hope we can add value to yours; give us a call to discuss your needs.