Most drug studies are being performed offshore and coupled with trends like adaptive trials. While this enables clinicians to modify studies based on their real-time analysis of data, the collection of data has become complex and costly. Delays during clinical trials can cost pharmaceutical companies lost revenue and opportunity costs of developing drugs that will never make it to market.
Historically, clinical trial information has been documented through paper-based processes that entail a clinician assessing a patient using pen and paper. It is estimated that 85% to 90% of clinical trials are still paper-based. Typically, the sponsor of the trial does not have access to data until it has been reviewed by a clinical research associate and sent to a centralized location for entry into the database, a potential delay of weeks or months.
Other pharmaceutical companies depend on patient-recorded outcomes (PRO). The self-recording of information by patients can be costly and time-consuming to implement, since it involves providing PDAs and other computing devices. In addition, older patients often are not comfortable using technology and are prone to delayed and error-ridden data entry.
Digital pen and paper technology
Research teams have adopted digital pen and paper technology to streamline the collection and processing of clinical trial data. Researchers can continue collecting information using pen and paper, while benefiting from instant uploading and processing of data.
Researchers write on pre-printed, digitally patterned forms with digital pens. The handwriting is converted to digital text and sent to the data management system for processing. Reports can be pulled from the data management system as needed. Researchers have access to information in a matter of hours.
The technology eliminates data entry, scanning, indexing, faxing, and mailing by interpreting handwritten information and converting data into digital text and is inherently redundant, because the original document serves as a backup to the electronic data. It automatically produces a digital image of the original document, captures and authenticates date and time information, and creates an audit trail to reduce the cost and complexity with regulatory compliance.
In addition, digital pen and paper technology requires minimal training, since users simply write on paper the way they always have. It is far more durable than other mobile computing solutions, which is an important consideration given the nature of global clinical trials.
Digital pen and paper technology significantly improves the flow of information across the clinical trials process. Researchers and sponsors have faster access to information in the field so they can make better decisions faster, which accelerates and improves the overall trials process. Organizations adopting this technology report a 50% average reduction in study timelines.
Best Practices for Seamless Adaptive Clinical Trials: Combining Agile Design and Operations. Health Decisions. Available from www.healthdec.com. Accessed on March 1, 2011.