Living in a Material World – What Is Needed to Run a Successful Clinical Trial
Making the decision to participate in a clinical trial is an important first step, but one investigator standing in an empty room cannot successfully accomplish anything. Careful consideration must be made regarding staffing needs, the facility, equipment, and data storage. The trial sponsor may mandate many of these specifications, and some of the related expenses may even be covered. This chapter will outline the basic requirements for managing a successful site, as well as some of the circumstances in which additional resources may be required.
Staffing Needs
Generally, the number of clinical trials and the scope of each of these trials will influence the number and type of staff needed. However, even for a very modest study, you, the principal investigator (PI), cannot manage all of the duties involved. It should not be dismissed that your primary and contracted role is to conduct the research. If you are distracted by having to handle clerical tasks, storage issues, and other concerns, the data and study outcome may be compromised. Furthermore, simple tasks can become monumental when they need to be completed by a certain deadline and are competing against regular practice business.
Each trial, regardless of size, should have a Study Coordinator. In light of the importance of this position, a separate chapter has been devoted to the role of the Study Coordinator, but a brief overview is provided here. Study Coordinators, although not required, are central to the clinical research enterprise, assisting with writing consent forms, recruiting subjects, coordinating with any outside hospitals or clinical units, managing audit requests, and collecting, generating source documents, and maintaining data. In addition, they usually serve as the main contact for subjects during the course of the trial. In summary, they manage the day-to-day operations related to the clinical trial.
Patient assessments often have to be made on a rigid schedule that necessitates the subjects returning to the clinic often. In addition, patient assessment visits may require special and limited equipment that allows for only a single subject to be seen at a time. A practice’s regular receptionists may not have time to meet the special needs of the clinical trial participants. Thus, having a dedicated receptionist, who knows the assessment schedule and any associated restrictions, is highly useful – especially if you have a large study population.
As the scope of research activities expands in your office, A dedicated person responsible for data entry may be required in addition to the Study Coordinator. Typically this “data manager” moves data from source documents into case report forms or electronic data capture software. Since this function offloads work from your coordinators, they are then able to devote full attention to the clinical aspects of the research study.
Other staff that may be necessary depending on the protocol include pharmacists, laboratory technicians, and additional support personnel. If hiring full-time and permanent employees is not an option, all of these positions can be filled on either a part-time or a temporary basis.
Facility
Some clinical trials require only minimal subject assessments (eg, physical examination, blood draw), while others necessitate involved procedures (eg, magnetic resonance imaging [MRI], stress testing). Evaluating a practice for suitability in a particular protocol is an important component of the decision to allow a research site to participate in a clinical trial.
Having a dedicated examination room for the clinical trial participants can save time for both the staff and the subjects. A room devoted to the clinical trial can be set up with all of the study-required equipment and supplies for optimal convenience. Having a dedicated examination room also ensures that subjects are not unnecessarily kept waiting while a room is occupied by a regular patient.
It may also be beneficial to have study subjects waiting in an area separate from the normal practice traffic, especially if the practice is busy or the study is evaluating a sensitive condition.
Additional staff and equipment necessitate additional space. Staff should have adequate room to carry out their responsibilities. For example, trying to integrate a fourth receptionist in a space that accommodates only 3 people creates an environment that is difficult for everyone involved. Similarly, additional equipment may take up considerable floor space or, at the least, require a repository when not in use. Innocuous supplies, such as syringes, will also need to be conveniently stored. Moreover, you may need additional telephone lines consigned to the clinical trial to accommodate scheduling and subject queries.
Be sure to take storage of the investigational compound into consideration when deciding to participate in a clinical trial. First, the compound may be sent to the practice as a bulk shipment for which substantial and secure space will need to be identified. Access to the compound should be limited to only those staff involved in the clinical trial. Second, the compound may have temperature and humidity requirements that, if not addressed, may invalidate the data from your site. Thus, a separate refrigerator or freezer may be needed. Lastly, additional precautions will be necessary if the compound is a controlled substance. See the Chapter on the proper handling of the investigational compound for more information.
The protocol may also require supplemental equipment that cannot be accommodated by your practice. Examples include laboratories, MRI assessments, mammography screening, and stress testing. In these cases, it will be necessary to procure the use of an outside facility to provide the additional services. These external laboratories or testing facilities must be certified and this certification must be documented. The study sponsor may or may not assist you with soliciting these supplemental services.
Equipment
In any given practice, even the most mundane tasks require the use of some form of equipment, whether it be a thermometer, blood pressure cuff, or a magnetic resonance imaging machine. A clinical trial may require similar equipment. In those cases where specialized tools are required, the sponsor will generally supply the device or cover the costs associated with acquiring it. However, it is important to understand whether you or the sponsor is responsible for maintenance of the equipment. Furthermore, the fate of the equipment following the conclusion of the clinical trial should be agreed upon prior to initiating the study. In many cases, the site becomes the owner of the less expensive equipment. Examples include dedicated fax machines, electrocardiogram equipment, scales, and temperature and humidity recording devices. This means that once the study is completed, the sponsor relinquishes responsibility for its upkeep.
The study site will need office supplies, such as paper for correspondence with subjects and the sponsor, folders for record keeping, and pens for taking patient histories. The costs (and storage needs) associated with these items should be considered when evaluating the appropriateness of your site.
Data Storage
A clinical trial sponsor may mandate a dedicated computer for the study or may allow any computer to be used. Usually, the sponsor will supply a software program for data entry. Data entry may initially be recorded on supplied forms at the time of the assessment; however, personal digital assistants (PDAs) are becoming more popular as a means of recording patient assessments because information can be easily downloaded into the main computer.
Regardless of how data are collected or where data are stored, the site may be required to maintain the records for up to 10 years or even 25 years for those in Canada. Through the adoption of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice, the US Food and Drug Administration (FDA), European Agency for the Evaluation of Medicinal Products (EMEA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) state that an investigator must retain records for a minimum of 2 years following the date a marketing application is approved/not approved for the indication under investigation, or development ceases. And sponsors and institutions may have additional requirements for record keeping. Thus, long-term storage may be required for large volumes of information, and the study sponsor may or may not share this responsibility with you.
Summary
Agreeing to participate in a clinical trial involves a multitude of details beyond just seeing patients. Staff requirements may need to be updated, and changes may need to be made to the facility to accommodate the influx of subjects, new staff, and additional equipment. Furthermore, the issue of long-term data storage will need to be addressed. However, if you review your current situation, you will most likely see that the adjustments considered necessary to participate in a clinical trial are not as substantial as you may think and will be well worth it.