Facing increased pressure to track long term outcomes in patients, companies are increasingly turning to Binto - who can proactively track patients who are on North American, European and Asian clinical trials - to ensure that sponsors and investigators have maximum access to their clinical trial subjects for as long as possible.
Privacy laws usually prevent clinical trial sponsors from knowing the identity of their patients.
This means that most sponsors must rely on the clinical investigators to maintain ongoing communication with their patients during the study and after it has finished.
Not surprisingly, it can be extremely difficult for investigators to have the time and resources to adequately keep up to date on the whereabouts of all their patients and as a result, many inevitably fall into the "lost to follow-up" category.
A survey performed by Binto showed that an average of 10 per cent of patients get lost to follow-up for every year of a study, and that two years after a study has closed out, sponsors can rarely reach 25 per cent of patients originally enrolled.
Melissa Easy, Binto's strategic relationship director, told Outsourcing-Pharma.com that this number can vary considerably, however, and can actually be much higher, depending on such factors as the phase of the trial, the type of product being investigated and the therapeutic area.
In a desperate attempt to track down lost patients that need to be found, many pharmaceutical sponsors have been resorting to hiring private investigators to work with the clinical sites - a method that is expensive, time consuming and often involves re-negotiating study contracts with sites to yield low results.
With this in mind, Easy said Binto is providing those in the industry - pharmaceutical companies, contract research organisations (CROs) and other affiliated service providers - an "independent, multinational service that actively maintains the contact details of clinical trial subjects during and after the study."
"To our knowledge, what we offer the industry is unique - there is no other service provider dedicated to doing what we are doing… In fact, even specialist patient recruitment and retention companies are including us in their pitches to pharmaceutical sponsors," said Easy.
"By providing email gateway, fulfillment and call-center services, Binto helps sponsors and researchers communicate quickly and consistently with subjects while maintaining the highest standards of privacy protection," she said.
Indeed, privacy is a major concern in relation to clinical trials.
Easy said that Binto follows data management and data protection procedures that "exceed standards" established by HIPAA in the US and the various European Privacy Directives in the European Union, and "regularly" audits compliance with other privacy legislation in "all countries where our services are available."
"Our patent pending patient tracking process not only ensures patient details are stored safely, but that these details are regularly confirmed and updated over time for each patient," she added.
According to Easy, Sponsors are increasingly using this service as part of their products' risk management plans, as well as to conduct very long term patient registries when it is unrealistic to expect patients to stay in one spot, or investigators to commit to long term involvement in a study.
In addition, regulators are increasingly asking questions about studies with large loss to follow-up rates, she said: "Regulators are questioning the sponsor as to why the patient dropped off the study and cannot be accounted for."
Reasons for patient drop out can include a simple loss of interest in participation, a relocation, adverse events or even death.
"The time taken to answer these questions can significantly delay approval times for products… in the worst case scenario regulators will count this missing person as dead for statistical analysis purposes, which is far from ideal," said Easy.
"By using Binto, sponsors can avoid this scenario because even if a patient is no longer on protocol we can at least document outcomes."
With the service Binto offers, Easy said that as soon as a patient is registered with them, which is optional at the time of signing up for the trial, the company can begin tracking the patient using the contact information they provided.
This registration process includes nominating two next of kin that the patient is happy for Binto to contact should the firm not be able to contact the patient themselves.
Easy added that by offering study subjects the chance to register and stay connected through Binto, it also becomes possible for sponsors to capture long term outcomes from patients (even those dropped off protocol), as the firm can contact them years down the track to obtain patient reported outcomes, such as whether they may have experienced any severe adverse events.
Having this option in place is also particularly useful for sponsors, as the regulatory bodies are increasingly asking for firms to conduct observational studies on drugs once they are on the market.
In addition, Easy said that many companies that have been using the service for a long time have built a database of patients from previous studies who may be eligible for further studies.
"This helps them shorten development times when they have multiple compounds in a particular therapeutic area."
Moreover, Easy said Binto can be used to promote patient retention through more effective patient communication between study visits.
"Sponsors spend millions of dollars on retention materials that pile up at sites and often don't actually get to the patients.
Using Binto, sponsors can make sure that these materials do reach their target."
"For example, we are currently working with a top ten pharmaceutical customer who is conducting a Phase III trial.
They came to us for help because they had already lost 50 per cent of their patients to follow-up and needed to improve patient tracking going forward," she explained.
Other important uses of the service are the ability to communicate important safety information to patients even after the study is finished.
"Most Phase III studies include exposure to experimental treatment protocols, yet patients rarely are informed about issues that may affect their health in a timely manner especially once a study has finished," said Easy.
"Binto is helping sponsors communicate with patients by helping patients stay more involved and informed about the study and their health, by acting as an intermediary between the sponsor, investigator and patient."
She added that having the service in place can also increase the attractiveness of a trial to a potential investigator.
"Investigators like it because we reduce the burden on them, so that they are no longer solely responsible for missing patients."
"One challenge in drug development is access to patients; another is recruiting good clinical investigators.
With sponsors investing so much time and money into their studies these days I don't understand why they would not include a direct to patient component as protection to the investment they have made," Easy said.