Clinical trials apply a scientific basis to the problems of human health and the proper management of such trials requires the use of human subjects, coordination with drug researchers and companies, and a vast amount of capital to conduct these trials over a period of time to prove the efficiency of a drug. Project management for trials has, therefore, become an almost separate branch of project management which requires the training of medical personnel or those associated with medicine to manage such trials.
Basic Objectives for Project Management for Clinical Trials
A project manager would have to be very aware of the clinical aspects of the project and understand the rigorous scientific basis of the trials, their methodologies, and the human aspects of the persons undergoing these trials.
The project manager needs to have and understand the correct measurement tools that will need to be applied for all aspects of the trials as well as the timeline in which they are to be accomplished.
Different project management methods would have to be examined and the ones most suited to the trials at hand would have to be adapted to managing the trials.
There must be definite standards established for recruitment of technical staff required to conduct such trials. Ethical standards from various countries would have to be kept in view and utilized. Financial constraints and budgets must constantly be within the knowledge of the project manager.
If subcontractors are involved or the processes or parts of the clinical trials are outsourced, the project manager would have to see that the agency so appointed conforms to all the technical requirements, methodology and budgets.
The project manager must arrange to provide all necessary documentation as required by the original researchers or clients so that these can be provided to the necessary scientific forums or government agencies when the trials are completed and the clinical trial drugs are ready for approval.
Using Risk Management in Project Management for Trials
At all times, all research teams, development teams, and the project manager need to be aware and involved in the risks of the clinical trial. These risks can be associated with the human element that is required for the trials and their well being and health. A good risk management plan should be written and utilized.
Risks may include unforeseen after effects of drugs in the subjects being tested and their consequent effect on cost for remedial measures. The molecule being tested could undergo changes not earlier foreseen in laboratory conditions and cause effects that are not easily remedied. Political factors can also cause a risk, especially where trials are being carried out in other countries that are sensitive to such issues.
Using project management for trials would ensure proper ways distribute or moderate these risks so they are manageable. Coordination with researchers and all concerned authorities plays a vital role and enables forecasting of likely problems. Finding out the root cause of all such problems plays a very important role and concerned management would have to continually analyze data while keeping in mind the overall objective of the trials and the time and budgets involved.
Using project management for trials, especially clinical trials, requires good risk management with clear objectives, coordination, and data tracking in order to be successful.