Clinical trials have so much on stake for a company, right from its time, resources to investments. Just to make things a lot worse, clinical trials are packed with uncertainties on several aspect. Wouldn’t it be awesome if there was a method to somehow predict the feasibility of a trial? In this blog, Swati Singh talks about the role of Clinical Development Feasibility Study Score in timely course correction so that the chances of a successful trial increases manifold.
What if you could predict the success/failure rate of your clinical trials? What the industry needs is some kind of a feasibility score that could help pharmas revisit their process and assure better scores and thereby a timely approval from the respective authorities and ultimately a successful trial balancing everyone’s blood pressures.
A Clinical trial has to have a protocol that acts like a guidance document for conducting the trial. This protocol describes the procedures that will be involved in the study, how and where it will be carried out and most importantly it also defines the type.
Why CDF?
Now, talking of Feasibility Study, it may be considered as a scorecard that may be used to predict the future of a Clinical Trial.
The feasibility check of a trial addresses various difficulties like finding sufficient numbers of eligible patients in a timely manner, identifying suitable study sites and qualified and experienced PIs to conduct the trials and evaluating the protocol to address aspects of the study design that may make it difficult to recruit and retain patients in the proposed study. Here, there is also the challenge of high cost of Clinical Trials and how any delays in the completion of a study can greatly impact the budget.
It helps Pharma companies gauge the likelihood of conducting a particular trial in may be a specific geographic region while keeping in mind the objective of concluding a trial with seamless alignment to cost and duration.
As a much known fact about Clinical Trials, they involve huge investments and challenging timelines.
Feasibility study helps Pharma stakeholders know the forthcoming challenges and prepare for the unseen circumstances, thereby shaping the future of a study in terms of its conduct.
How would the feasibility score help?
Often studies that need to be carried out in a specific geographic region but due to insufficient patient enrolment would need a shift to some other geography which may not be the apt choice in the first place. All this and more can be figured out from the Feasibility Study Score that could be based on the following parameters:
- Availability of sufficient eligible patient pool in the desired geographic region
- Practical timelines
- Availability of investigators with the desired expertise and past experience in the region and their readiness to enrol for the trial or their engagement with another competent trial
Investigator’s understanding of the target patient pool
- Availability of facilities with the basic requirements for the study
- Agreement of the enrolled patients and investigators agree to travel to these facilities for the trial bearing in mind the schedules of these investigators along with the associated expense
Feasibility Study Score helps in predicting the speed with which the investigators are likely to hit the Target Recruitment Rate on the enrolled sites.
At the end, a poor feasibility score also throws light on the possible reasons for insufficient patient enrolments, which could be due to one or more of the following:
- The inclusion/exclusion criteria may be too restrictive
- The ideal patient recruitment rate may not be convincing
- The required number of facilities for the study may not be available in the specified duration
- The protocol design may be too complex
Here is a snapshot of the trends observed in delays witnessed in Oncology Trials
Delays have been increasing every year and this is a fact. There are some factors against which the feasibility study is carried out and that would help in preventing or anticipating the delays.
What are the major factors to be considered while designing a Study?
Major factors considered and weighed in order to score a protocol, if taken care of well, may lead to a near-excellent Feasibility Score:
- Availability of a suitable patient populationThis is the first most important factor of a Protocol. It’s not just the availability of patient population for a trial that is important but the availability of evaluable patient population.A user defines certain inclusion/exclusion criteria in order to define the characteristics of the patients to be enrolled for a study.Factors affecting the enrolment are:
- Anticipated patient recruitment rate as compared to the recruitment duration
- Complexity of the Protocol
- Similar studies causing a conflict to the study in discussion that can lead to competition for the patient enrolment
- Location of facility
- Duration of the treatment
- Too restrictive inclusion/exclusion criteria thereby leading to reduced pool
- Availability of Investigators
An investigator having similar experience is the most preferred candidate but there are Physicians who may not have that experience but are close to the patients since they may have treated them. This set of physicians also form good candidate pool as since they are closer to the patients, there is higher probability of them succeeding at enrolling the patients for the trial.- The investigators must be experienced enough to carry out the trial smoothly
- There must not be conflicting studies for the investigator where he may have enrolled already or finds more convincing to win over the trial in subject
- Availability of Sites
Most preferred site for a trial are the ones that- Have all the recommended facilities required for the trial
- Are not too distant from the target patient pool as well as Principal Investigators
- Where similar trials have been carried out and were completed successfully
- Where there are no ongoing trials consuming the required site resources
- Study Design Complexity
For every trial there may be certain Lab Tests, Procedures, Examination that the target patient population would be expected to undergo. The degree of invasiveness of these procedures could cause major impact on enrolment of patients. Generally, higher degree of invasiveness may cause back-outs.For conditions that are absolutely incurable, in a hope of the molecule in subject curing it to an extent may push patients to even adopt invasive procedures. This will then be driven by the primary diagnosis.These four factors together may lead to a solid Feasibility score, looking at which the success of a Clinical Trial may be predicted and this gives rise to the need of a solution which could help Pharmas anticipate this success score, considering the increasing need and following of Clinical Trials.Each protocol undergoes a systematic evaluation of all the major aspects of proposed Clinical Trial, before commencement of a study. Such a pre-study evaluation will reduce likelihood of costly protocol amendments, timeline overrun due to slow enrolment, high screen failures and other preventable challenges that are commonly experienced in RCT (Randomized Clinical Trial).