PRO Transcription is a must for pharmaceutical companies
Drug testing is a complex and costly process, so it stands to reason that a new drug cannot simply be released into the marketplace without undergoing rigorous testing. After all, pharmaceutical companies need to be certain that their products are safe to use. Once new drugs have passed stringent laboratory and animal testing procedures, clinical trials using humans are the next stage in the process.
Clinical trials are used to determine whether (or not) a drug is effective and if it has any side effects. One useful way of determining how a drug behaves is to interview patients. Clinicians and caregivers can report back their findings during a clinical trial, but since the patient is the one taking the drugs and therefore has firsthand knowledge of how their body is reacting, they are the best source of useful information. As a result, Patient Reported Outcomes (PROs) are increasingly being used in clinical trials by pharmaceutical companies for the development of new drugs.
What are Patient Reported Outcomes?
Patient Reported Outcomes, or PROs as they are otherwise referred to, are in simple terms a qualitative interview in a controlled environment whereby the patient is asked a series of questions to identify issues, side effects and a patient’s individual experiences with a particular drug. An interview with a trained interviewer is the best way to facilitate the sharing of in-depth information, but written questionnaires may also be used. It is even possible to collect a Patient Reported Outcome via electronic means – patients can use computers and apps to report back symptoms via an electronic PRO application. Patients can then be monitored in case medical intervention is necessary. However, due to the limitations of written questionnaires and e-PROs, transcriptions of in-depth interviews remain the best method of recording Patient Reported Outcomes.
The Role of PROs in Drug Development
Patient Reported Outcomes are becoming increasingly important in clinical drug trials. Although the information gained from PROs often matches that of objective test outcomes, PROs have the added benefit of giving researchers useful insight into things that are not so easily measured by clinical tests. For example, patients may report minor side effects that are not relevant to the effectiveness of the drug, but nevertheless could prove troublesome if the drug was eventually passed by regulators for mainstream distribution.
What is PRO Transcription?
Verbal PRO data collected during a recorded interview with a patient in a clinical drug trial needs to be transcribed before it can be used by pharmaceutical companies. It is essential that the transcription of such data is done ethically and accurately. In order to protect patient data, all files must be destroyed once the information contained therein has been transcribed.
How Useful is PRO Transcription?
Pharmaceutical companies are becoming increasingly aware of how important Patient Reported Outcomes are in the development of new drugs. Transcribed PROs help pharmaceutical companies meet their regulatory requirements. They also help them serve the needs of patients.
Transcription services need to be 100% accurate. Even minor mistakes in data interpretation could potentially affect results in clinical drugs trials, so it is important that only professional transcription companies are used.
Alphabet have been supplying the pharmaceutical industry with accurate transcriptions since 1995. If you are involved with a clinical trial and need assistance, get in touch today – we’d love to help!