The purpose of this book is to illustrate and provide guidelines and information for planning and conducting a successful Clinical Trial from the Project Management perspective. Project Management is the application of planning, knowledge, skills, and technique to execute projects effectively and efficiently.
It will also describe the processes from beginning to end, and link these processes to key stakeholders and Good Clinical Practice (GCP), all of which are critical to the success of a trial (Table 1.1 and Fig. 1.1).
Table 1.1
What Is Good Clinical Practice?
GCP provides guidelines as defined by the ICH, an international body which defines standards that governments can transpose into regulations for clinical trials involving humans. These standards are referred to as ICH-GCP or ISO-GCP.
It is a standard for clinical trials, which includes the design, conduct, performance, monitoring, termination, auditing, recording, analysis, reporting, and documentation of clinical trials. These standards ensure that the trials are scientifically and ethically sound and that the clinical properties of the pharmaceutical product under investigation are properly documented and the data and reported results are credible and accurate. It also ensures that the rights, integrity, and confidentiality of trial participants are protected.
GCP guidelines therefore protect the human rights of participants in a clinical trial and provide assurance of the safety and efficacy of the newly developed compound. These guidelines also require detailed documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. It defines the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. Quality assurance and inspections ensure that these standards are met.
The aim of GCP is to provide Investigators and their study teams with the tools to protect human subjects and collect quality data.
Why Do We Do Clinical Trials?
Clinical trials are designed to answer a specific research question. They are used to determine if a new biomedical or behavioral intervention is safe, efficacious, and effective.
Good Research Questions are:
ā¢ Clear. They are easy to understand and unambiguous.
ā¢ Specific. They are specific enough to understand what constitutes an answer.
ā¢ Answerable. It is clear what data we need, to answer the questions, and how the data will be collected.
ā¢ Interconnected. All the questions are related in some meaningful way, forming a coherent whole.
ā¢ Substantively relevant. They are nontrivial questions that are fundamentally worthy of the research effort and cost.
Some approaches are:
ā¢ To evaluate interventions (drugs, medical devices, etc.) for treating a disease, syndrome, or condition.
ā¢ To evaluate interventions that will identify or diagnose a particular disease or condition.
ā¢ To find methods to prevent the onset or recurrence of a disease or condition (medicine, vaccines, lifestyle changes, etc.).
ā¢ To investigate and identify methods to improve quality of life and comfort for patients with chronic illnesses.
These approaches have to follow GCP guidelines as defined by the International Council for Harmonization (ICH) and subsequently adapted in many countries (Table 1.1).
Medicines Regulatory Authorities
In the case of trials involving an investigative medicinal product, regulatory requirements include approval by a medicines regulatory authority (MRA). The MRA is responsible for ensuring that all clinical trials of both nonregistered medicines, and new indications of registered medicines, comply with the necessary requirements for safety, quality, and efficacy. Applications for clinical trials and for registration of medicines and medical devices are reviewed by a MRA expert committee, which considers among other issues the scientific, medical, and ethical issues of the applications. Reports on the progress of the study are sent to the MRA on a regular basis. Proof of safety, quality, and efficacy must be submitted when applying to the Medicines Control Council (MCC) for approval and registration of a med...