The best practices for clinical trial operations are difficult to define/describe due to clinical trials being diverse in nature. Yet there are certain requisites that are universally relevant to all clinical trials and best practices can be adopted within these requisites for a clinical trial. The following is a list of such requisites.
- Pre-clinical trial provisions
- Defining a protocol for the clinical trial
- Adhering to standards in protection of trial subject
- Defining investigator and sponsor responsibilities
- Site selection
- Patient recruitment
- Regular monitoring of observations and events
Preclinical trial requisites:
Before launching a trial, the sponsor of the trial in consultation with clinical investigators needs to justify and establish a study protocol for conducting the clinical trial. An improved method of establishing protocol is by interacting with patients and volunteers, and including their points of view in the protocol so that patient recruitment is better during trials. Clinical investigators need to be assessed by the sponsor if they possess the required qualification and expertise.
Defining a protocol:
This refers to identifying the core objective or aim of the clinical trial and outlining the details of the resources required to conduct the trial. This will involve conversations with clinical investigators and sponsors primarily who will design a standard protocol. Sponsors will then need to develop standardized procedures to oversee operations in concordance with local regulations and costs. Case report forms are an example of a document required by all clinical trials. Hence developing one and updating it regularly is considered a best practice.
Adherence to protection of trial subject:
This is a core principle of pharmacovigilance where the safety of the volunteer/patient is of paramount importance. The Declaration of Helsinki provides a template and standard on which the sponsor can lay out ground rules for implementing adequate safety measures to protect volunteers/patients. This is useful in conducting a trial in an ethically justified manner and hence this will always be considered a best practice. Setting up an ethics committee to monitor the ethical aspects of a trial is also another best practice.
Investigator and sponsor responsibilities:
The clinical investigator has to sign a written agreement agreeing to abide by the protocol arrived at earlier and good clinical practices. He/she is also responsible for selecting trial subjects in an unbiased manner and in sufficient numbers as per protocol. He/she is responsible for the care and safety of the subjects during the course of the trial.
The sponsor is responsible for providing required information and investigation resources like drugs to the clinical investigator. They are also required to follow scientific principles in designing the protocol and ensure that local regulations, as well as global laws, are followed in the design and implementation of their clinical trials.
Selecting a site to conduct a clinical trial is important to ensure the safety of patients involves and efficient use of available resources. Best practice for choosing a clinical trial site is to ensure that it has adequate laboratory and medical facilities to meet any contingencies, should ensure that patient safety can be guaranteed on the site and that adequate staff is available to coordinate trial procedures.
Patients/volunteers need to be recruited through informed consent from them as well as their personal physicians if present. This is a best practice to avoid negative misconceptions among patients and community physicians who hesitate to participate in trials.
Monitoring of the clinical trial:
All successfully conducted clinical trials possess a common trait and that is, they monitored the clinical trial operations constantly and recorded each and every one at a time-bound manner. This is considered to be a universal best practice with respect to clinical trial operations.