The process of launching a clinical trial can be daunting for an inexperienced researcher and his or her team. From carefully reviewing a research protocol to navigating the IRB process, the researcher and team must ensure certain steps are followed to comply with federal and state regulations, as well as their own institutions’ policies and procedures.
One important element in launching the clinical trial is developing and negotiating a clinical trial agreement and budget with the sponsor. This critical step ensures that that the costs of carrying out the trial are covered.
Karen Roth, BRANY’s legal counsel, shares some of the common pitfalls that investigators encounter, which are common causes of delays.
Sponsor reporting of safety issues — Federal regulations require sponsors to submit safety reports to the FDA and participating investigators conducting studies with any investigational drug. For institutions using AAHRP-certified IRBs, such as BRANY IRB, there is a requirement to demonstrate how adverse events are reported.
“When BRANY is negotiating contracts with sponsors on behalf of institutions, we request language that goes beyond what is required under the law,” says Ms. Roth. The sponsor continues to receive data, even if the study has ended. “We require that our sponsors provide information regarding safety data that might impact the health of former subjects for at least two years after the termination of the study.”
Indemnification — An indemnification clause in a research contract is basically a promise by the sponsor to defend the investigator and the institution and to cover financial losses if there is patient harm or illness as a result of the trial.
“With the exception of institution’s potential negligence, we try to negotiate as broad an indemnification as possible,” says Ms. Roth. “Because the product belongs to the sponsor and the protocol is written by the sponsor, we want to ensure the institution is indemnified for claims arising from the study. It will be the responsibility of the researcher, however, to ensure that the protocol is followed to the letter.”
Subject injury — This is similar to indemnification, but it covers the cost of diagnosing and treating a patient who may have suffered harm or injury as a result of the trial. Since some injuries may be latent, it is important to have this provision survive the agreement indefinitely.
“It is our expectation that the sponsor will pay for diagnosis and treatment of a study injury without the institution having to seek reimbursement from insurance,” says Ms. Roth. “Our subjects are volunteers. We cannot expect them to rely on private insurance, which may be limited, to pay for research expenses. In addition, we make every effort to ensure that subjects will not need to incur the legal fees associated with a formal legal claim in order to have their medical expenses covered.”
Intellectual Property — Sponsors expect to own intellectual property developed as a result of the studies they fund. This expectation can conflict with the mission of the institution to conduct its own research and develop its own intellectual property. We work with sponsors and institutions to clearly define the ownership rights of each party. Investigators who conduct their own research should keep such projects completely separate from industry sponsored projects. It is inappropriate for an investigator to use study data or specimens from an industry sponsored study for investigator initiated research.
“In no case should an investigator use a sample taken from a patient during previous sponsored studies,” says Ms. Roth. This needs to be clarified and articulated in the contract.
Study contracts exist to protect the interests of sponsors, investigators and patients. But there are common pitfalls that often require careful legal review and experienced negotiation to ensure the important elements are in place — even if it means a slight delay on the start of the trial.