To whom your patient registry/clinical registry system will help?

There are multiple users, from the medical, research, and allied fields who can take direct and indirect benefits of your web and mobile registry applications such as:

  • Researcher are at top
  • Sponsored companies, which are aiding the project financially
  • Doctors in Gov. organization and in big hospitals
  • Doctors in private clinics and small hospitals
  • Nursing staff
  • Laboratories Gov. & non-Gov. which are going to arrange clinical trials
  • Pharmacy companies which are want to know postproduction results
  • Medical equipment producing companies which want comparative trials
  • Marketing companies for drugs and other medical components interested in supportive data
  • Universities and medical institutions

How different stakeholders perceive the possible benefits from the patient registries or clinical trials in different ways?

There are different perspectives of different people from various industries for the data collected through patient registry or clinical trials such as:

  • At clinicians’ Point of View: with the help registries applications on web and mobile clinicians can collect enough data rapidly for disease presentation and outcomes on large numbers of patients, thereby they would have a real-world picture of disease, its prevailing current treatment practices, and their outcomes
  • At Point of View of physician organizations: with the help of a registry they will get adequate data that can be used to assess analyze the degree to which clinicians are managing a disease with the help of evidence-based guidelines, they can pay attention on specific aspects of a particular disease that might otherwise be overlooked, it also provides data for clinicians to compare results and their methods with others and their work for better clues for effective treatments
  • At customer/patient/payer’s Point of View: with the help of registries you can obtain detailed information from a huge mass of patients on how procedures, devices, or pharmaceuticals are working and used in practice and how they are effective among different kinds of populations. This way they can determine their coverage policies
  • At drug or device manufacturer Point of View: with the help of a registry-based study they can get broad picture of the performance of a product in the real world, can see how it meets a post marketing commitment or requirement and can develop hypotheses based on that. Moreover, they can identify patient populations that will be useful for various purposes like product development, clinical trials design, and patient recruitment

What are the general benefits of patient registry or clinical trials?

However, benefits of such registry software or application are varying from person to person and industry to industry, but we can sum up them as following ways:

  • It is directly contributing in Generation of knowledge and evidence for the scientific presentations and publications for the relevant professionals
  • It will demonstrate you the effectiveness or comparative effectiveness of drug or treatment or device among the different populations
  • You can gauge whether you are meeting post-marketing commitments or not
  • It will generate evidences for coverage
  • You can obviously monitor safety aspects
  • It will help you to manage risks and benefits
  • You can generate true data for new indications or label extensions if needed
  • It will help you to change behavior
  • You can use it as the tool to improve quality of care
  • With the help of it you can prove product value through economic or quality of life benefits in general sense
  • You can bring scientific information on the table of stakeholders rapidly and economic ways
  • It will assists you to enhance the practice of personalized medicine
  • You can use it to observe the course of disease
  • It will help you to understand variations in treatment and outcomes
  • You can examine factors that influence prognosis and quality of life with the help of registry
  • It will help you to describe care patterns, including appropriateness of care and disparities in the delivery of care through functionalities such as feedback of data

What are the main differences between patient registry development and clinical trial programming at different perspectives?

Of course, there are plenty of differences between patient registry development and clinical trials development at concept level as well as benefits level and some of them are:

Patient Registry

Clinical Trials

Patient registry studies are observational by nature Clinical studies are investigational by nature
As sponsors, we are passive observers in a patient registry study because we tell the physician to treat the condition as per their wishes As Sponsors, we are active researchers in a clinical trials study as we instruct the investigator to treat the condition in a certain manner
All the basic elements of design, planning, and project management are present in patient registry programming and designing, but there is a lack of consensus standards for registry studies therefore, it is difficult to find guidance on how to do them Here all standards are predefine and prevailing in industry therefore, consensus on them is easy process for clinical trials studies
However, patient registry is consider as a valuable post-approval tool, which is providing evidence of the real-world results of medical products, therapies, and relevant services In a nut shell, clinical trials are giving important data about treatment effects in controlled conditions, though trial data are often not applicable to the diverse population they need the further interventions in the post-approval setting
At one hand patient registry can close some evidence gaps by offering additional data, to judge whether products or procedures are safe and effective or not at all With clinical trials you can get some evidence gaps that may

  • impede the ability of patients and
  • influence providers to make informed treatment decisions and of
  • affect patients/payers to determine what sorts of coverage will be appropriate
With patient registry you can collect data on a broad population albeit, with a few exclusion criteria and can evaluate care as it is actually provided. Thus, registry data are consider as more representative of the real-world patient experience However, in some conditions clinical trial is not feasible to carry for

ethical or practical reasons and can’t get actual vision of product or treatment

With the help of patient registries

You can solve various objectives, such as:

  • You can describe the natural history of a disease
  • You can determine clinical and cost-effectiveness
  • You can monitor safety
  • You can measure quality of care
While in case of clinical trials these all are not possible at some extent

What is involved in the planning phase of patient registry?

In planning phase of patient registry or clinical trials we identify the all stakeholders involved and define the scope of data required.

  • We define what we need to know with this registry
  • We try to identify the patient outcomes
  • Define target audience by setting exclusion and inclusion criteria
  • Define the budget/funding others and we need to accomplish these tasks
  • We set up designing and programming team as well as formulate QA policies and its team to carry out tests and types, nature, and cost of tests
  • We setup team leaders and project managers as well as ask for the formulation of monitor boards or committees if needed
  • Define the final goal or exist strategy so we can know that when we have to stop this study believing that it is complete successfully

How do you design study for patient registry?

We have mainly three options for study design such as:

  • Cohort Design: we can notice an end point of outcome in a group of people after some span of time and based on we draw conclusions of clinical trials or patient registry
  • Case-Control Design: Here we have to segregate cases of patients who show our desired out comes and compare them with the group of patients who lack that (controls)
  • Case-Cohort Design: This is nothing but variant of case-control design and controls are sampled from a list where equal probabilities persist for being sampled in patients

What care do you take when you collect the data for clinical trials or patient registry?

We are already familiar with peculiar languages of Registry enthusiasts from RCTs and many of their concepts. Therefore, we collect data from:

  • The personal domain of patients such as demographics, health status, medical history, or patient identifiers like Social Security numbers (SSN), other personal identifiers to identify individuals in the National Death Index (NDI)
  • The exposure domain of patients like their experiences with the technology or device
  • The outcomes domain of patients like primary endpoints, secondary endpoints, technology deficiencies, and adverse events
  • From the potential confounders such as a drug being taken to treat the same condition as the study device

We develop a data management manual to define

  • How missing data will be handled
  • How invalid entries will be handled
  • How data will be cleaned, and what level of error will be accepted
  • How data will be tracked and coded
  • How query reports will be generated and resolved and how it will be stored and secured
  • Finally, we describe a quality assurance system for data entry and registry procedures

 

What considerations do you do prefer for sponsoring companies, which are taking part in clinical trials or patient registry?

We expect some ideal situations and standards for participating companies like labs, pharmaceutical companies, research firms, or universities such as

  • Their purposes should be clearly stated and articulated with the sponsoring organization
  • They should define an appropriate strategy to achieve the purposes and how the data from the registry will fit into the overall evidence program
  • They should first identify their stakeholders
  • They should define target population, on which the registry results should be applicable
  • They should define scope of the registry with the primary and secondary objectives
  • They should define the source of appropriate funding
  • They should have plan for using the data, from internal purposes to publications to regulatory reporting including creating an analysis plan
  • They should define adverse event reporting requirements and should be clear and understood by everyone involved in the program