With Molly Huggins
When most people think about clinical research, they imagine the development of new wonder-drugs or devices that ease pain and suffering and extend our lives. Those conducting clinical research, however, have to consider the myriad technicalities—both scientific and legal—that will determine whether their research endeavor will come to fruition.
Molly Huggins leads a team of medical research attorneys devoted to helping clients get clinical research projects up and running. In the following Q&A, she provides direct insight into the industry, and addresses some current and future challenges.
What types of companies or organizations touch clinical research?
Our clients include academic medical centers that perform clinical research as a part of their core mission, pharmaceutical companies that are engaged in drug development and sponsorship of clinical trials, community hospitals participating in multi-site clinical trials, biotech companies that provide research support services, and physicians who participate in clinical trials.
What are the most common legal challenges facing them today?
This is an extremely heavily regulated industry, so the challenges are many, but billing compliance is at the top of my list right now. Medicare requires specific budget and billing processes related to clinical trials, and these can be daunting. Billing for device trials can be particularly complex, due to certain approval processes under Medicare that must be followed. When we are working with a client who is performing a clinical trial, we want to look very closely at the budget and billing pieces with them, to be sure all the right steps have been taken and documented. When our client is sponsoring the research, we help educate them about the steps the sites must take in setting up the billing process for the trial, so that they can help provide the sites with sufficient information on a timely basis.
It’s also important to understand that there are an enormous number of players involved in a clinical trial (even before you bring in participants), and risks have to be fairly allocated among them. Contracts between clinical trial sponsors, sites, and investigators must be carefully drafted and negotiated. Confidential disclosure agreements, clinical trial agreements, material transfer agreements, data use agreements, and informed consent documents all have to be carefully considered. Consistency among the documents is another key matter – we serve as a final set of eyes for our clients to make sure the clinical trial agreement, budget, and informed consent documents all align. With different parts of an organization involved in preparing each one, it’s not surprising that the final documents often contain inconsistencies among them related to the same trial.
Intellectual property issues also arise with research, as well as day to day operational questions that arise from our clients’ internal institutional review boards, research finance departments, and federal grants offices.
What new legal issues have emerged in this field?
Without a doubt, patient privacy and the intersection of research and access to patient data is at the top of our minds. Over the years, we have seen sponsors of clinical research and entities performing clinical research generally come to a good understanding of how to properly protect subject confidentiality. Recently, however, we are seeing a rise in the involvement of contract research organizations and other third parties in clinical trials. When a third party is involved that is not the sponsor or the site, we need to think carefully about when that third party has access to protected health information, and who is responsible if that third party improperly uses or discloses the protected health information. These are issues that are not commonly addressed in the research agreements or informed consent documents, and we are encouraging clients to really engage on this issue.
What have sites and sponsors found surprising when negotiating a clinical trial agreement and budget?
We often see sponsors caught off guard by requirements that must be met by sites in order for the agreement and performance of the research to be consistent with the sites’ non-profit status. This generally comes up during the negotiation of publication and presentation rights for Phase I and II clinical trials, and we always encourage sponsors to think through these issues while in the drafting stages of their clinical trial agreement template.
We also find that sponsors are generally not as focused on health care compliance laws, such as the Anti-kickback statute and Stark laws, that hospitals and physicians must navigate when performing clinical trials that are paid for by an outside party. When sponsors work with counsel who is well versed in these requirements, we find the negotiation and finalization process for the agreements goes much more quickly.
What red flags are you asking your clients to be particularly attuned to?
Post-market studies and registries. We have seen a number of very quirky agreements in the past six months, all of which have been post-market studies or registries. These raise particular compliance concerns when there is the possibility that they could influence a health care provider in his or her referrals for a particular device or product. When our clients have a proposed agreement for the performance of a post-market study, we look very carefully at whether the study has genuine scientific merit, whether participation in the study could improperly influence referral patterns, and whether performance of the study is consistent with the client’s non-profit status, if applicable. Sometimes the arrangement turns out to be fine, but we’ve had a number of circumstances recently where we have advised the client to decline the study.
What legal issues are on the horizon going forward?
Billing compliance and patient privacy will continue to be critical issues. Financial disclosures and issues related to transparency in research are also getting a good bit of attention, and we have a number of clients who are real thought leaders on this issue. We consider ourselves fortunate to be a part of this industry.
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