Organization and Monitoring of Clinical Trials

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Introduction

Psychotherapists have always preferred using placebos as a way of making their patients develop positive attitude towards a given medication. According to Harrington (1999), placebos are inert drugs given to patients in order to improve their psychological conditions while in the process of receiving physiological attention.

Given that the drug is inert, it does not have any physiological effect on the patient. However, the patient will believe that the drug is functional, and they will develop a feeling that their physical condition is improving.

This condition has always been described as placebo effect. Clinicians often use it as part of improving the psychological state of their patients. However, there has been need to find real solutions to patients who need physiological and psychological attention. For this reason, Perfect Sponsor has come up with a Wonder Drug that would be able to offer these patients real solution other than basing the treatment on false beliefs. This therapeutic agent will be able to help patients who have physiological problems that need therapeutic attention.

Super CRO has been contracted to conduct Phase III North American registration trial in order to determine the safety and efficiency of this wonder drug. It is important to develop a clear plan of the activities that would be carried out before the project can commence. The plan must specify individuals who will be participating in various activities, and the time each activity is estimated to take. The project will target adults aged from 18 to 75 years.

Site Selection

Site selection will be the first activity that would be undertaken by the project members. Perfect Sponsor has stated that it desires to have 20 sites in Canada and another 20 sites in the United States. This means that the project will cover 40 locations in total. The first activity would be to select 20 individuals who live in the United States and another 20 in Canada.

These forty individuals must be clinicians who have some administrative experience. They will be selected from the hospitals that have been sampled to participate in this project. In Canada, the participating hospitals will be Bassano Health Center, Oilfield General Hospital, Boyle Health Center, St. Mary’s Hospital, Our Lady of the Rosary Hospital, and Cochrane Community Health Center.

Others include Daysland Health Center, High River General Hospital, Hinton General Hospital, Sacred Heart Community Health Center, Medicine Hat Regional Hospital, Milk River Hospital, Big Country Health Center, Raymond Hospital, St. Paul Health Care Center, Taber Hospital, Three Hills Health Center, St. Joseph General Hospital, Viking Health Center, and West Lock Health Center. In the United States, the participating hospitals will include St. Mary’s Hospital, Ronald Reagan UCLA Medical Center, Duke University Hospital, Johns Hopkins Hospital, UCFS Medical Center, Cleveland Clinic, Massachusetts General Hospital, and Indiana University Health Center.

Others include University Hospital of Cleveland, University of Michigan Health System, Vanderbit University Hospital, Mount Sinai Hospital, Yale New Haven Hospital, University of Iowa Hospital, Ohsu Hospitals, UPMC Presbyterian Shadyside, Barnes Jewish Hospital, Shands Hospital, and University of Wi Hospital.

The administrators at these selected sites will be the project team leaders at these sites. They will be working directly with the project coordinators. There will be two project coordinators. One will be in charge of the operations in the United States while the other will monitor operations in Canada. The entire process is expected to take two months, from January 1 to February 28.

Investigator meeting

When the above forty team leaders have been confirmed, a meeting will be held at the head offices of Super CRO in the United States. The two regional project coordinators will also accompany these team leaders. The project coordinator will chair the meeting that will also be attended by selected officials from the Perfect Sponsor.

Given that the Perfect Sponsor is the owner of this project, it is important to ensure that its officials are present during the induction process. The fact that these team leaders will be responsible for all the activities taking place at their assigned sites, it is necessary to conduct the induction process with a lot of precision.

The induction will be conducted by doctors from the Perfect Sponsor in close coordination with clinicians of Super CRO. This process is estimated to take a period of one month, from first to thirty-first of March. The team leaders will be guided on what to do while at the site. It is believed that one month is enough to make them be able to participate in this project successfully.

Master File set-up and Regulatory Document Collection

When the induction process is completed, the next activity will be setting up of master file, and development of regulatory document collection (Tonnquist, 2009). As mentioned, this project will take place in two different countries at forty locations.

The geographical locations of these places are far apart, and it is necessary to ensure that data collection process is done properly to make this project successful. It means that the documentation must follow a given pattern that is clear and easy to follow-up. For this reason, the project manager will develop an online filing system. The two regional coordinators will be assigned twenty team leaders as per the country of participation.

The regional coordinator in the United States will be given a code name of US, while that in Canada will be given the code CD. Each of the forty-team leaders will be assigned code numbers based on the codes of their regional leaders. This means that those from the United States will have their codes starting from US1 to US20.

Those in Canada will have their codes starting from CD1 to CD20. This way, it will be easier to determine the regions where each participant is coming from, and the particular participant based on the code they have. All the team leaders, the regional coordinators, the officials from the Perfect Sponsor, and the project manager will be present in order to make it possible to understand the identity of the participants. An online database will then be developed, and each of the codes entered.

The team leaders will be expected to identify themselves using the codes. However, their names will be reflected on the codes to enhance clarity. However, the names will not be released to the public during the final release of the report. The report will only identify them using these codes. This process is expected to take two days.

Protocol Development

The next stage will be the development of protocol. In every project, it is always important to develop a clear protocol that would be used to guide all the activities that will be conducted. In the development of protocol, there will be need to have all the participants in this project. At this stage, the officials of the Perfect Sponsor may not be needed. This does not mean that they are restricted from attending these sessions.

However, their role may be of limited use at this stage. The reporting protocol must be made clear to all the participants. The information on what should be conducted and any necessary adjustments will be coming from the sponsor to the project manager. The project manager would then pass this information to the two coordinators. These coordinators will be expected to communicate directly to the team leaders. The team leaders can then direct the individual participants at their sites as may be necessary.

The order of seniority will follow this channel. This means that at no stage will any information be passed without following the correct path to the head office. The team leaders will collect information from the field and pass it to the regional coordinator. The regional coordinator will pass this information to the project manager who will then be able to inform the sponsor of the progress being made in the project.

However, the officials of the Perfect Sponsor are allowed to intercept this information at any point in this channel. When this happens, the officer responsible at that stage must inform the superior that the officials of the sponsor had intercepted some information. This information must reach the project manager so that he can determine how to inform the sponsor on the progress. This is expected to take one day. The team leaders, project coordinators, and project manager must be present at this stage.

Case Report Form Development

The next stage will involve case report form development. The forty-team leaders must have a clear common method of reporting their findings to their superiors. It is important to ensure that the manner in which the team leaders in different regions in the United States report is similar to the way team leaders in Canada report.

This means that it is necessary to develop a universal case report form that would be used by all the team leaders. This must be done when all the relevant officers are present. In fact they would be involved in coming up with the right format. The two regional coordinators will head the process of developing case report form in presence of the project manager. The regional coordinators will engage the team leaders in coming up with the most appropriate report form.

The process would involve comparing some of the previously used case report forms. The team will develop a form that meets the present needs in the best manner. When this is completed, the project manager will engage the two regional coordinators in developing another case report form that the two will use to compile reports from the team leaders and then report to the project manager.

The project manager will also involve the two officers in developing a form that he will use to compile the two reports into one document that shall be sent to the Perfect Sponsor. This process is expected to take one week. The officials of the Perfect Sponsor will be expected to attend the meeting so that they may understand the way the report will be made.

Study Drug Management

The next activity will be the study drug management. This very sensitive area will need total concentration of the members involved. This is because it involves development of a prototype that will be used in the field. The special doctors from the Super CRO who were involved in the development of the wonder drug will head the process.

They will be responsible for the induction process that will take place at this stage. The members needed at this stage include the project manager, the regional coordinators, the team leaders, officials from the Perfect Sponsor and the special doctors.

The doctors will head all the sessions at this stage. They will start by explaining the way placebo drugs have been used and their impact in enhancing the conditions of patients. They will explain how psychologists have used these drugs to improve conditions of their patients. They will then explain to the team members some of the special features of the new wonder drugs. They will inform the team members the history of this drug, some of the success stories it has, and any other special characteristics that makes it superior to the placebo drugs.

The specialists will try to compare the two drugs, identifying some of the benefits of the new wonder drug to the patients and medics. The project manager and the two regional coordinators will act as secretaries at this stage. They will take notes on all the proceedings at this stage. The team leaders are expected to be very active during this process. They are expected to pose any relevant questions to the specialist because they will be at the field.

They may face challenges in the field, and therefore, must attempt to ensure that they are fully equipped for the activities ahead. The specialists will make all the demonstrations needed in this research. They will respond to all the questions posed. In essence, they will be trying to ensure that the participants will be able to handle all the needed issues in the field. This process is expected to take a period of two weeks. It may be extended to one month or more based on the prevailing conditions.

Regulatory document checklist

It is important to understand that this is a new drug that is being introduced for the first time. It is necessary to have clear documents that will support the drug release.

As Böttcher (2003) notes, this is a legal requirements that must be observed during this project. The team leaders will need this document when they are in the field to validate their activities. They will need to present the document to various regulatory authorities in their respective regions. The most important document at this stage will be the Medical Release Form that will be used to grant consent to introduce this new drug.

All the scientists who were involved in the development of form must sign. In the form, they must state the entire process that led to the development of the drug, and all the elements in it. The document must state some of the side effect that comes with the use of the drug. The document must also state how the side effects can be managed. The project manager must sign the document as an indication that he has approved the project.

Site feasibility assessment

The feasibility assessment will be conducted in two regions in Canada and another two regions in the United States. The two regional coordinators and the financial officers in this project will conduct this activity. The choice of the two hospitals will be made randomly. These officers will determine if there is need for the project, and the costs it will take. They will then determine the benefits of the project. They will finally make a conclusion as to the advantages of using this new drug.

Agenda for Investigator Meeting

In a meeting, there must be a clear agenda explaining some of the activities that will be carried out (Nagarajan, 2005). It helps in guiding such meetings. The following is the agenda of the final meeting that will be carried before the team members are sent to the field.

Agenda 1: The project manager making official opening remarks and welcoming all members to the meeting

Agenda 2: Activities to be undertaken in the field by project members and the desired duration

Agenda 3: Some of the challenges that the project members will face in the field and how to mitigate them

Agenda 4: Meeting government officials in relevant offices to explain this project

Agenda 5: Any other business

Conclusion

This project is expected to bring a complete change in the medical field. Placebo drugs have been used for a long time to treat patients. However, recent reports have shown that the placebo drugs are not ethical because they give patients false impression that they have been treated. This wonder drug is expected to introduce an efficient and effective way of phasing out placebo drugs.

References

Böttcher, H. M. (2003). Wonder drugs: A history of antibiotics. Philadelphia: Lippincott.

Harrington, A. (1999). The placebo effect: An interdisciplinary exploration. Cambridge: Harvard University Press.

Nagarajan, K. (2005). Project management. New Delhi: New Age International.

Tonnquist, B. (2009). Project management: A complete guide. Aarhus: Academica.

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