INTERNET RECRUITMENT

“Clinical trials now have the potential to conduct research study using World Wide Web… [the Internet] that have the ability to recruit people themselves, enter their data into our computers, and provide fast and convenient electronic recruitment process”

ABSTRACT

“Recruitment-the key for a successful clinical study”

Recruitment is a dialogue that takes place between an investigator and a potential participant prior to the initiation of the informed consent process. It begins with the identification and enlistment of volunteer subjects or controls for the clinical trial. The use of the Internet in randomized controlled trials has grown tremendously in recent years. In order to reach a large target population of study subjects, an effective mechanism for recruitment is needed. To generate results on time and complete trials, completion of recruitment on time is essential. A small delay in recruitment leads to delay in completion, and thus a financial loss for the sponsor.

INTERNET RECRUITMENT 

“To market the product immediately, sponsors must explore new subject recruitment techniques”

“Time to market” is one of the important quote in clinical trials. The faster the study gets the approval, the more financial value it will have for the company. Delays in study will be very costly to the CRO’s. It is therefore easy to understand why patient recruitment has been called “the most important and challenging aspect of clinical trials,” with pitfalls in recruitment process is one of the main reasons for the failure of clinical studies.

Less number of subject enrollment into study will have many negative implications, such as highly expensive with extra resources and longer duration of clinical trials. In addition, poor recruitment process not only impede the successful evaluation of new and existing interventions, but it will also prevent greater efficiency in clinical development. Thus it is very clear that subject recruitment is a key phase in the clinical trials. If the subject enrollment period in clinical trials could consistently be reduced, it would cause a major advancement in optimizing clinical study process and improving economic health of the company.

ONLINE RECRUITMENT OF PATIENTS

The internet is playing the major role in recruiting subjects. Prior to internet most subject were recruited for studies through their physicians or perhaps through mass media advertising. Although this form of recruitment has enjoyed a degree of success, it has limitations that can affect how quickly a site meets its recruitment targets. The US Food and Drug Modernization Act of 1997 required the Department of Health and Human Services to establish a registry of clinical trials for both the government and the private sector. As a result a new trial enrollment was launched and with the home page banner as “linking patients to medical research.” The site was launched in Feb 2000 and currently contains approximately 11300 clinical studies sponsored by the National Institutes of Health, other US government agencies, and the pharmaceutical industry in over 90 countries. The website provides basic information on clinical trials and information for people considering to participate in a trial.

SPEED, EFFICIENCY AND COST-EFFECTIVE

The advantages to using internet for recruitment are many. With the push of a button, a sponsor can potentially be in numerous homes or doctor's offices across the globe. There is nothing to print out and physically mail. In the world of clinical trials, time is of the essence. Every hour saved translates into the potential to complete the trial on time or ahead of schedule, thereby getting a product to market faster.

ACCESSIBLE, CONVENIENT TO COMMUNICATE 

       Website can be used as a powerful means of communication for trial personnel (investigators, monitors, sponsors and committee members). The clinical trial website can be used for the following tasks: providing information to study subjects, and investigators listing contact information; and globalization of data handling for patient registration, randomization and data collection.

INTERACTIVE CAPABILITIES

In this era of advanced communications technology, if people have questions they do not have to wait for a longer time for an answer. Clinical website enables to respond quickly to the subject queries. Thus this will speed up the process of recruitment. The faster the sponsor completes the recruitment process the sooner trial can move forward. In addition, faster recruitment process will save money in the long run and minimize the time to market.

CONFIDENTIALITY CONCERNS

Security is a central issue when considering the Internet for sensitive information exchange. Although internet provides many options and opportunities to sponsor are in recruitment process, there are also challenges to be aware. As more and more information is exchanged through the website, there is a risk of hacking the confidentiality of the subjects. However the risk of people hacking into the website can be reduced by applying 21 CFR part11 compliance, encryption is also available for email communications and a well-defined quality assurance process to maintain the integrity and confidentiality.

ETHICAL AND REGULATORY CONSIDERATIONS

Regardless of different strategies used in the subject recruitment process, ethical and legal issues must be considered. Each clinical study has its own unique inclusion and exclusion criteria. Ethical committees and regulatory bodies will ensure that safety is of the highest priority.

CONCLUSION

        As competition for clinical trial subjects continues to intensify, sponsors and investigators need to broaden their strategies for recruitment and retention. Internet can be used in each and every step of the clinical trial including protocol development, identification of funding opportunities, recruitment, registration, randomization, data collection, analysis, publication and communications. Internet can enhance the clinical studies in such a way that multi-centered trials are more manageable, less expensive, easier to administer, and less time-consuming. The major pitfall of online trials is the security and integrity of the documents that are collected and transmitted electronically. Hence in future we can look forward to internet technologies that enhance the security to the electronic data. 

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Written by
Vanitha Paloju
vanitha.archana@clinzen.com