Clinical trials involve research conducted on humans that is designed to evaluate the effectiveness of a drug or treatment and add to medical knowledge. As per the National Institutes of Health (NIH), “Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people.”
Clinical trials are usually medical or clinical studies in which human volunteers participate in carefully conducted investigations according to a pre-determined research protocol. The clinical trial program is a long drawn process taking up to 5-7 years or more to complete. A clinical trial is usually conducted as the final step of an extended research process. First, a new medical strategy, drug, treatment, or device is developed in the lab, then it is tested on animals, and finally tested on humans to see how safe or effective it is.
Types of clinical trials
Broadly speaking, clinical trials can be of two types:
Based on the purpose of the study, the NIH has classified clinical trials into the following types:
Quality of life trials:
Registration of clinical trials
The Declaration of Helsinki states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” Organizations like World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) are strong advocates of clinical trial registration. All journals listed on the ICMJE website require registration of clinical trials in a public trials registry before the first patient is enrolled as a condition of consideration for publication. ClinicalTrials.gov run by the United States National Library of Medicine (NLM) is the world’s largest and most widely used clinical trials registry. The WHO maintains a clinical trials registry network. The ICMJE accepts registration in ClinicalTrials.gov or in any primary registry of the WHO International Clinical Trials Registry Platform (ICTRP). Once the clinical trial is over, the results data should be submitted to the registry. While the ICMJE encourages submission of results as a good practice, this is not mandatory.
Case report form for clinical trials
A case report form (CRF) is a paper or electronic questionnaire used in clinical trial research to record all protocol-required information on each subject/participating patient in the study. Case report forms contain data obtained during the patient's participation in the clinical trial. According to the International Conference on Harmonization Guidelines for Good Clinical Practice, a CRF is “A printed, optical or electronic archive intended to record the greater part of the protocol– expected data to present to the sponsor on every trial subject.” It encompasses the entire medical history including adverse events from the patient and is collected over a period of weeks or months.
The CRF should accurately represent the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. The CRF assists in obtaining the complete, comprehensive and standardized data collection that promotes efficient processing, analysis, and reporting of information, as well as the exchange of data across sites. The data from the CRF is further used by clinical research coordinators, biostatisticians, investigators, data managers or a programmer.
The main purpose of a CRF is to gather complete and accurate data in a clinical trial and to smoothly transcribe the data from the source document to a retrievable form. In other words, a CRF preserves and maintains the quality and integrity of data from a clinical trial. The structuring of the CRF should enable data collection of the highest quality. The sponsor/pharma company usually designs a CRF. The sponsor should ensure that the CRF represents the trial protocol; additionally, the sponsor is also responsible for management of the production, monitoring of the data collection and the auditing the content of the CRFs. However, the patient’s name and medical record number are usually de-identified before sending the details to the sponsoring agency.