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29
Feb

Integrating Patient-Reported Outcomes Trials By A Contract Research Organizaton

Posted by Posted on in health_care
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When integrating patient-reported outcomes, a Contract Research Organization needs to follow best practice guidelines to ensure safe and efficient conduct of the trial.

 

Here are some best practices to be followed by an Oncology CRO services company to ensure the patient gets the best outcome:

 

Patient-Related Outcomes (PRO) Data Quality

 

A key factor in Patient-Related Outcomes is the protocol or quality control of the PRO data. Programming and statistical effort are also important, as is central monitoring, specialized forms, and training for the people who will be involved in administering the PRO measures to patients.

 

Incorporating the PRO outcomes in an oncology clinical trial through the use of the protocol is required to assure good, quality PRO data by a Contract Research Organization.

 

The preparation phase before developing the protocol with the PRO measure is important and input needs to be sought from clinicians, oncology nurses and clinical research associates.

 

These could include specific symptom areas that might be missing, and also to get their agreement on the need for including general quality of life outcomes for that particular study.

 

Feasibility of the PRO Assessment Schedule 

 

It is very important to have input from the people involved in treating the patients.

Doing this assures the clinical relevance and schedule feasibility, which leads to better compliance with PRO data collection.

 

It is important to identify someone to be the PRO study coordinator in terms of being able to answer specific questions about the PRO measures.

 

The Statistical Centre review of forms and procedures needs to occur to ensure compatibility with the type of data collection and database system for that particular group conducting that study.

 

An example of this would be the National Cancer Institute Meta Data Rate system, which PRO majors now have to address.

 

PRO Assessment Protocol

 

It is necessary for a Contract Research Organization to have the PRO data, addressed throughout the protocol itself as this data is an important component of the trial.

 

Here is what needs to be included in the protocol:

 

Firstly, PRO questions should be specified as primary or secondary objectives. This should be made clear in the objective section of the Oncology CRO services protocol.

 

In the background section, it is very important to communicate the rationale for PRO outcomes. This indicates the scientific value of collecting PRO data in the trial.

 

The clinical trial treatment arm section of the protocol should have instructions for treatment delivery and required clinical outcome measures. Where and when the PRO forms are to be administered, should be indicated.

 

This is true for the study calendar also, so all PRO forms should be listed in the calendar showing all the assessment time points.

 

This allows the Oncology CRO services nurse or clinical research associate to see when these forms are due and what is required.

 

In the endpoint and analysis section, the PRO outcomes should be indicated again, specifying whether they are primary and secondary outcomes and how they are being measured.

 

The criteria for determining clinical significance should be clearly indicated.

The PRO objective statistical analysis plan needs to be described. If this is an Oncology CRO Services trial with advanced-stage disease patients, then the analysis plan for the PRO majors needs to address the potential for missing data.

 

Another section of most contract research organization protocols has to do with data submission instructions, which should clearly indicate when the PRO forms are due and how they are being collected.

 

 If there's a need for a special instructions section of the protocol, this can give more detailed information about administering the PRO forms, and indicate rules for such issues as an assessment is missed what should be done.

 

The time frame to capture data for phone interviews and mailed forms is also important as is the availability and requirements for any kind of training to administer PRO forms.

 

A reference is also needed in the PRO forms for clinically significant benchmarks and the analysis method for obtaining the PRO data.

 

Copies of the PRO forms should be easily available to the research staff if they are not in the protocol.

 

Programming and Statistical Efforts

 

Including PRO measures require a degree of effort on the part of programmers and statisticians.

 

PRO forms need to be prepared and be in compliance with the system of forms in the particular group conducting the trial. New data entry programs may need to be produced and some revisions for electronics submission of data could also be required.

 

A system data dictionary for the PRO majors needs to be prepared, and programs for monitoring submission of the PRO forms also have to be established.

 

Quality Assurance Through Central Monitoring

Central monitoring is a key factor in ensuring the quality of the PRO data and it is important to have the ability to monitor form submission regularly.

One of the aspects helpful to research staff is the ability to request missing forms or missing data at an earlier point in time. It is also necessary to identify institutions who are having problems turning in forms than allows for intervention, so those institutions can be helped.

 

It is important to see that the cover sheet for the form is submitted. There is important data on the cover sheet such as the contact information for the person who completed the form.

 

 It also gives reasons for data that were not administered and whether or not in this assistance was required.

 

Statisticians and programmers can produce email reminders that the nurse PRO coordinator can send out weekly to an institution about an upcoming patient assessment.

 

This email will include the nurse PRO coordinator’s role and the reasons why the institutions are receiving the email – such as overdue PRO forms or anticipated PRO forms.

 

Patients identified by cooperative groups will have a cooperative group ID number and initials along with with forms due and the date due.

 

Reminders also need to be given to institution staff about when the PRO assessments or all scheduled assessments are supposed to be collected, even if the patient is no longer receiving treatment.

 

Cover sheets are to be completed and submitted with every set of PRO forms and include the nurse coordinator contact information. The email contact can be revised to address new or different issues associated with a particular trial.

 

Even with all the quality control efforts, statisticians play an important role because the best quality control has no effect if data is missing due to death or deteriorating health.

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Tagged in: clinical research

 

 

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