Entrypoint i4 logo

Entrypoint i4 logo

Clinical Trials—Data Management

Data management is an essential component of clinical trials. It consists of designing the clinical database, collecting trial data, and quality management—ensuring that all data conform to the FDA Title 21 CFR Part 11 and other FDA/ICH guidelines.

A data manager determines how data are collected, and monitors the data to make sure that they are complete, accurate and consistent. Good data management requires continuous monitoring and audit tracking. Poor data management can cause delays and loss of revenue—or worse, compromised patient safety and data of questionable validity. Good data management is the subject of many books, including Management of Data in Clinical Trials by Eleanor McFadden, and Clinical Data Management by Richard K. Rondel, Sheila A. Varley, Colin F. Webb (eds).

Data Tracking

Detailed tracking is the only way that the FDA can confirm that drugs perform as the pharmaceutical companies and contract research organizations claim. When a drug company submits data to the FDA, the company must be prepared to document and justify all changes to the database. The data must demonstrate that all patients qualified for the study, that there were minimal side effects, and that the drug had the effect reported.

In addition to conforming to FDA guidelines, pharmaceutical companies and CROs must also deal with the threat of litigation. If the validity of any data is questionable, legal action is a possibility, and the cost of suits can affect company profits. A well managed trial database with fully documented changes and a complete audit trail reduces the chance of lawsuits.

Changing to a Paperless System

As costs mount and time to market becomes crucial, clinical data management groups are more motivated to find faster ways of producing clean data. One option is converting from paper-based data collection to electronic data capture (EDC). Switching to electronic data capture can streamline the management of clinical trials, which leads to lower costs and shorter clinical development time.

Up to now, the results of adopting electronic data capture methodologies have been mixed. This is primarily because many companies making the change have failed to get buy-in from all principals involved, and have not made the necessary operational changes that go hand in hand with such a conversion. Companies that have made a full commitment to the new methodology and all it entails see a significant reduction in time and cost.

Companies that capture data electronically can store trial data in databases. Retrieving data is fast, easy, and available at any time. Databases offer additional possibilities:

  • It is possible to retrieve subsets of the data, organize them in any order or format, and perform calculations.
  • Data can be integrated and analyzed across trials.