There can be a lingering risk of a claim in clinical trials?

One of the growing areas in the healthcare field is the area of Clinical Trials.  Clinical trial liability insurance is taken by companies to protect themselves from the risks arising from bodily/physical injury caused to the individual during the process of clinical trials.  The policy protects the research, contract organization from legal liability in some cases.   There can be a lingering risk of a claim in clinical trials:

Post-trial risks of up to two months are also covered.    *…there are some exclusions to the coverage:  such as failure of drugs and nuclear chemical risks are usually excluded from coverage.

According to the Business Standard:

The clinical trial segment could see a period of stable and sustained growth, as the market is expected to become more professional for trials.  As the investment by Pharmaceuticals continues to grow, so will the need for Clinical Trial Liability Insurance.  Specialty and General insurers are developing their products and their underwriting guidelines to support this niche.

Pharmaceutical companies and contract research organizations (CROs) are consumers of the product.  Pharmaceutical Companies are investing in continued support for their new drug introductions, the process of obtaining FDA approval requires contract research organizations which know how to get the process done and the research completed.  Some of the Producers with whom we work, namely Eric Sawyer of World Wide Facilities is expecting to move toward more streamlined underwriting, more latitude in the minimum premiums and broad form coverage to support this niche.

Gisha George, head-liability insurance, Bajaj Allianz General Insurance said there could be a drop in the number of clinical trial policies after the new regulations covering the process.

New Insurance coverage will protect the organization and the investigators from claims naming them in the implementation of the trial.

Coverage Supports Participation in Clinical Trials

There were some thoughts expressed on The Doctors’ Company website about the importance of the clinical trial liability insurance policies by Bill Fleming, RPLU, Assistant Vice President, Underwriting.

Professional Liability for Clinical Trials

Virtually all professional liability insurance policies exclude coverage for claims arising out of the use of drugs, devices, or protocols not approved by the Food and Drug Administration (FDA). This type of risk is excluded in basic policies due to concerns regarding patient safety and the defensibility of claims alleging human experimentation.

The Doctors’ Company has recently made important changes to their policy, adding this coverage to their insured physicians.

Bill Fleming said in his article:  “As a company owned and led by physicians, The Doctors Company supports participation in clinical trials by its members. A powerful example of this commitment is the broadening of our policy to provide automatic coverage for member participation in clinical trials. It is no longer necessary to obtain preapproval from us for specific institutional review board (IRB) clinical trials.”

Endorsement MPL240 is added to new and renewal policies issued on or after January 1, 2009, subject to state regulatory approval.*

So, clinical trials approved by an Institutional Review Board are now covered by the policy.

    Typical requirements for clinical trials include the following:

·         There must be a written protocol for use approved by an appropriate human subjects committee or institutional review board.

·         Full disclosure (informed consent) with a clear explanation of all potential risks must be made to the patient, signed, and placed in the patient’s chart.

Coverage applies to clinical research trials conducted within either an institutional setting or in a physician’s office setting—provided the trial has been approved by an IRB.

Please note this change does not convert your professional liability policy into a clinical trial or clinical research organization errors and omissions policy. If you are a sponsor or operate an IRB, you should consult with your insurance adviser regarding your insurance needs.

The process of approval

When a clinical trial protocol for an investigational new drug (IND) or a new drug application (NDA) is submitted by a drug company to an institutional review board for approval, it also submits the protocol to the FDA. The FDA has some time to review and comment;  independent of the IRB review.   Once approved by the IRB, the clinical trial takes place, and, when completed, the results are then submitted to the FDA for its approval of the new drug or new application.

A physician who has been asked to perform work for a clinical trial may be asked to sign a contract shifting liability from the clinical research organization or pharmaceutical to the physician.  These ‘indemnification clauses shift the responsibility the physician and the physician’s insurance company.   These contracts are basically asking the physician to agree to be the liability insurer for the sponsor. Because of the almost unlimited liability potential, The Doctors Company cannot extend coverage to its physicians for liability that they assume in indemnification or hold harmless clauses in such situations. Any contracts, particularly those in the arena of clinical trials, should be reviewed with your health care business attorney.

However, we will cover you alone for your work with the clinical trials.  Our members can rest easy that, of all the administrative tasks required for clinical trial work, malpractice insurance paperwork is not one of them. Your coverage has been broadened and redesigned to fit the reality of 21st century medical practice by automatically covering you for clinical trials.

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