Modern medicine and the development of modern pharmacological treatments are mainly based on the findings within clinical trials. Most Western governments including the US require multiple clinical trials to prove claims of effectiveness for surgical, mechanical or pharmacological treatments before approval for mass application. Even before the stage clinical trials on humans are approved multiple steps of pre-clinical trial testing is necessary in laboratory conditions with accurate and consistent documentation. Clinical trials test the bounds of treatments, their effects on multiple patients in a variety of stages of their illness and provide efficacy data within each subset. Without standard efficacy regulations the medical industry could be seen as snake oil salesman once again.
Clinical trials have developed over thousands of years. Although their history before 1750 is brief and sporadic different ancient authors refer to ask clinical trial process for testing drugs and surgical procedures. One of the most infamous clinical trials was James Lind’s demonstration that citrus fruits cured scurvy in 1747. Sailors forever afterwards were appreciative of clinical trials. In the US clinical trial process includes five phases including:
- Phase 1 – is a trial on a small number of humans to ensure it is safe without severe side effects.
- Phase 2 – still only a small number of participants are used to ensure the therapies safety and efficacy and if there are benefits from the treatment.
- Phase 3 – is considered the benchmark phase and compares the new treatments efficacy against current standards and usually involve hundreds of participants.
- Phase 4/5 – after approval by the FDA phases four and five examines the effects of the therapy over several hundred or thousand participants to further evaluate the effectiveness of the treatment on a much larger scale.
Types of Clinical Trials
The US National Institutes of Health (NIH) classifies clinical trials into five separate categories by their purpose:
- Prevention trials – generally include drugs, vaccines, supplements or lifestyle changes to provide better ways to prevent diseases or from the diseases returning.
- Screening trials – are used to detect the best way to detect diseases or other health concerns.
- Diagnostic trials – are conducted to establish new ways of detecting disease or illnesses.
- Treatment trials – are experimental therapies involving surgical, mechanical or drug therapies.
- Quality of life trials – are experimental care trials to establish better comfort and quality of life care for chronic illness patients.
- Compassionate use trials – are used on small groups of patients for which there are no current therapies or treatments available and all other treatments or therapies have failed.
Clinical trials in the West are highly regulated including those who can participate, those who can conduct the trials even down to the documentation procedures required for clinical trials. Some of the largest companies involved in clinical trials use very sophisticated clinical trial software to aid in documentation and project management of the trial.
As in any business in the modern world computing, software and documentation play very important role in clinical trials. This software if designed properly will ensure government regulations and requirements are met and will keep the project on task with various options to ensure control, security and effective data management. Current demands for pharma companies and health treatment therapy organizations require software solutions that can track requirements across multiple governments and international regulations for potential multiple zone implementations. As clinical trials have developed as the forefront of research and development for new medical advances software has needed to innovate in order to keep up with these changes. Great clinical trial software should include the following components:
- Clinical Data Management
- Drug and AE Coding
- CDISC Programming Services
- Statistical Programming
- Biostatistical Consulting
- SAS Programming
- SAS Consulting
- Medical Writing
- Customized FSP Models
- Staffing and Recruitment
With a full service solution the software options can provide a consistent and quality clinical trial.
Small and large clinical trial departments and companies need a flexible clinical trial software solution to be able to meet the needs of discerning consumers, trial participants and exacting federal and international regulations and standards.
By David Horowitz of ClinPlus, a company whose mission is to provide software solutions and services aimed at improving the clinical trial process while reducing operating expenses.