This week’s contribution to ’52 Perspectives’ comes from Debbi Lindgren-Clendenen, APRN-BC, GNP and Vicki Carmack, both Principal Consultants at NaviGo Research, a full service contract research organization providing clinical trial guidance and resources to the Medical Device, Pharmaceutical and Biotech industries.
1. What are some steps your company takes to make the recruitment process go smoothly and successfully?
Recruitment starts with a good protocol inclusion/exclusion definition. This ensures that the inclusion and exclusion criteria of patient enrollment are very clear, precise, and applicable to your cohort for the desired data outcome. There are many different types of recruitment tools and novel approaches to this phase of a clinical trial. A common, successful approach is to request your investigator, during the qualification visit, to address an approximate number of patients he or she feel they may be able to approach at their site in screening for your trial and potential enrollment. This gives the Sponsor an educated guess for this site in relationship to its location and patient demographic,
Follow up and tracking of the site’s recruitment is critical. Ask these questions of each site: How well are they performing this task? Are they meeting their stated enrollment goals? Are they keeping up on patient recruitment or was it just an initial push at the kickoff of the trial? Do they revise strategies often if their initial plan is not working? Answering these questions for each site and tracking enrollment is key for the sponsor. Decide prior to the start of the trial, what different recruitment techniques may be implemented at sites that are struggling and ensure that they are allowed by IRB(Institutional Review Board)/EC(Ethics Committee) and individual site.
Printing small pocket sized cards of the inclusion/exclusion criteria is another common practice that sponsors will implement to help research coordinators in successful subject recruitment.
2. How do you ensure that the subjects in clinical trials have a good general understanding of the research being done to them?
The informed consent process is critical for any trial. Regulations for consent content and IRB/EC requests must be followed. Regulations at an international, national, regional and local level must be incorporated into the subject consent form. Proper consenting starts with the ability to understand the information within the consent form and the ability of the investigator to communicate to the subject the trial’s methodology, the instructions of how the investigatory product will be used, and the potential risks and benefits might be for inclusion into the study. The supportive information is typically contained in the IFU (Instructions for Use), Investigator’s Brochure and ROP information. The language used by the investigator and the supporting materials, including the informed consent document, must be at an educational level appropriate for the desired subject population. This level is typically targeted at a fifth/sixth grade reading level. A documented consent process of verbal information, which includes common subjects’ questions and the investigator center’s answers, must be obtained as well as the documented evidence that the consent form was reviewed and understood by the patient.
A witness or representative/guardian of course must be used as applicable in the situations needing this provision. Consenting prior to any trial activity is a must and must not be perceived as being obtained under any duress of decision. Researchers should give plenty of time for the subject to review prior to signing, ask questions, consult with family members or others in order to make proper determination of involvement and understanding of what they are about embark upon as part of the clinical trial.
3. Does the government in your country play a role in educating citizens who participate in clinical trials? How?
Yes. In the United States, there are many different websites and clinical trial information centers that are both sponsored by the government and/or from the private sector that can help answer research questions and educate subjects on the research process. FDA (Food and Drug Administration) regulations and EU (European) standards are specific to assuring subjects have pertinent information prior to trial participation. Subjects involved in global clinical research may now retrieve various technical support information as well as request mailed information on similar products and preliminary clinical trial information regarding safety and effectiveness.
4. Give me an example of a public-private partnership between your government and a contract research organization like yourself that really worked.
The FDA potentially publicly partners with all sponsors of medical device clinical trials in the sense of offering the opportunity to discuss the specifics of the company’s investigational product approach for marketing approval as well as reviewing the trials main objectives and statistical approaches prior to its submission to the FDA for formal review.
As a contract research organization, we have been involved in these partnerships on behalf of our customers (the sponsors) representing them in these discussions with the government. These partnerships are never private. Many of the customers that we have worked with in the past have placed high value on the FDA pre-trial discussions as it provides valuable insight into options that may provide a better or more efficient approach to marketing approval outcomes
5. What does your company do in clinical trial documentation and analysis that increases success for new drug approvals?
We work with both Device and Drug approvals using our proprietary data management software. Our data management services as well as trial management services have increased success in many trials for our clients by capitalizing on its built-in efficiencies. Our ability to have validated services with real time data entry, review, and reporting have helped many clients achieve their research data goals by reviewing the data at any given time during the trial. In addition, the valid and prompt reporting using real-time data analysis has been key. Compliant trial conduct using our clinical trial management software has been a highly requested service by our clients. We also offer management and set up of data review committees such as DSMB (Data Safety and Monitoring Board) and CEC (Clinical Events Committee) that real-time management of adverse event data during the trial as well as the ability to code it using MedDRA. This promotes speedy set-up times for these committee meetings, thus resulting in full adjudication, then assessment.
Using our services and systems for trial data management, trial development, management, and compliance maintenance can reduce common errors. We pride ourselves in achieving the most efficient process of trial set up and data collection, keeping in mind our clients resources and being efficacious with them. Ultimately, this should help in the process of reaching the desired trial endpoint(s). Our clients range from small start- up companies to large, well- established companies in need of extra help and services. Our combined years of experience and expertise help them to streamline trial goal paths in order to achieve their product marketing approval, whether it is providing the initial or further expanding the marketing indications. We use current technologies and industry knowledge to help our clients to achieve their desired outcome.
6. How is the current economy hurting or helping recruitment?
The clinical research subject-recruiting environment is stronger than ever, as many subjects are aware of clinical trials and what it might mean to be part of one. The current economy does not seem to affect the subject population in clinical trial recruitment except for a subjects’ savvy in requesting travel reimbursement and other compensations.
However, the current economic situation is noticeably impacting venture capital funding and private investing for small companies trying to get their product into clinical trials. Patients seem to be eager to involve themselves in trial related therapies or treatment, however companies are limited on their payments related to trial related expenses due to the lack of adequate funding or strict control of trial budgets. It appears to be a “Catch 22” due to the investor demands asking for clinical data prior to funding release or approval. Most small startup companies need the money to start their trials and usually do not have prior human data beyond preclinical testing to support further investigation. Investors are requiring more human data in order to secure funding (more human data to help determine if this investment will have positive outcomes). This cripples the small startup company that is depending on funding for any clinical expense, especially those that are introducing novel technologies of therapy and treatment. In addition, governmental agencies are astute in requesting more safety data then they had in the past, thus trials are taking longer or are not starting as quickly as they did in the past. Public opinion continues to support the role of the governmental agencies to be the strong “ enforcer” in order to protect the subjects. Right or wrong, companies, whether large or small, must be smarter, more efficient, and have a precise strategy to achieve the goal to market, and recruitment is a secondary issue.
NaviGo Research, Inc. is a full service contract research organization providing clinical trial guidance and resources to the Medical Device, Pharmaceutical and Biotech industries. Our comprehensive expertise, integrated approach and unique ability to find creative solutions provide our clients the peace of mind that their trial is in good hands.