Clinical study – Where is the project management here?
Since the global pandemic caused by the Covid-19 virus, the topic of vaccine development, phases I - IV and the success and failure of the vaccine candidates has been on everyone's lips. The discussions about Vaccine A, which produced very good results in Phase I, or Vaccine B, which failed in Phase III, are indispensable. But what does all this mean and what is the purpose of the term "project management" here?
What is a clinical study?
A clinical study is a research study in which certain questions about a new vaccine, a new therapy or a new drug are systematically tested on test persons. Questions to be clarified in this study include how effective one drug is compared to another, what side effects are caused by the treatment and how economical the treatment is.
What happens during this study?
A clinical study runs according to a detailed and specified test plan, the study protocol. Here it is determined how long the study lasts, what requirements and criteria are placed on the test persons, what level of drug dosage is to take place, which tests are to be carried out and how medical care is ensured during and after the study. All endpoints and information must also be described and submitted to the approval authorities at the end of the study in order to obtain market approval and thus ensure that the cost bearer will assume the costs. These requirements are very specific, strict, and address broad ethnic principles and legal standards. A so-called approval dossier is the result of this protocol. A clinical study runs in four defined phases.
• Phase I: A small number of healthy participants (max. 10). In this phase, the aim is to find out what effect the investigational medicinal product has on the body. The focus here is on security.
• Phase II: A large number of sick patients (max. 300). The goal in this phase focuses on different dosages and their impact on the patient. The focus here is to achieve the greatest possible point of effect without inducing toxicity.
• Phase III: A very large number of sick patients (<3000). The goal in this phase is to confirm the efficacy and established point of effect within the dosage.
• Phase IV: After successful approval of the preparation. The goal is to find out to what extent the investigational drug can be combined with other drugs. An assessment of the long-term effects of the treatment will also be made. So-called AD (adverse events) are recorded and evaluated.
What does a clinical study have to do with project management?
The answer is simple: a clinical trial is a project. This is a research and development project. And as with any other project, project managers are also required here who keep an eye on the costs, the performance and also the time of the project. Project managers take on very special roles as the interface between medical practices, pharmacies, clinics, but also sick patients, healthy test persons or suppliers or logisticians. Here, too, there are defined timelines, work packages, goals and non-goals, and a critical path.
What is the difference between a clinical study and the other project types?
There is not much difference between a project in the field of clinical studies and any other project. The methods of project management, the project letter, the stakeholder analysis or the project structure plan always remain the same. However, there are some nuances in which the types of projects differ.
In contrast to information technology projects, it is very difficult to apply agile project management within a clinical study. If a piece of code for a piece of software is stuck, it is possible to work on another piece first. If phase I of the study is not completed, it is neither permitted nor possible to start phase II. Furthermore, stakeholder management is more time-consuming due to the diversity from logisticians to seriously ill patients. It is important not to lose sight of the people and the individual and to achieve a balance between the magic triangle, customer satisfaction and the health and resilience of the test subjects.
A clinical study is an extremely exciting project with many interesting challenges, which has rightly caught the public's attention in times of the corona virus. Are you planning a clinical study or do you still need support? Talk to us and we will guide your study through experience to success!